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Sleeping Pills, Insomnia, and Medical Practice: Report of a Study (1979)

Chapter: Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options

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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 88
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 89
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 90
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 91
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 92
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 93
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 96
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 97
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 98
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 99
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 100
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 103
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 104
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 105
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 106
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 107
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 108
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 109
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 110
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 111
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 112
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 113
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 114
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
×
Page 115
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
×
Page 116
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
×
Page 117
Suggested Citation:"Chapter 4: Insomnia: Research Findings, Diagnostic Approaches, and Therapeutic Options." Institute of Medicine. 1979. Sleeping Pills, Insomnia, and Medical Practice: Report of a Study. Washington, DC: The National Academies Press. doi: 10.17226/9934.
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Page 118

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Chapter 4 INSOMNIA: RE SEARCH FINDINGS, DIAGNOSTIC APPROACHES, AND THERAPEUTIC OPTIONS A. The Meaning of Insomnia Insomnia is a subjective complaint that is related to or caused by a variety of disorders. As with many other types of subjective distress (dyspepsia, or back pain), much ignorance surrounds the nature of the problem and the value of the relief commonly provided in modern health care. Most health care professionals have assumed that patients who complain of insomnia accurately describe their night-time sleep. When this assumption has been examined in the clinical sleep laboratory, however, surprising findings emerged: in many cases the actual sleep of patients complaining of insomnia is hardly disturbed; there is an enormous overlap in the objective laboratory measures of sleep between insomniac patients and age-matched, normal controls.* In some cases, the complaint of insomnia is completely unrelated to sleep or to daytime alertness. Although many sleep laboratory studies have shown, that, as a group, insomniacs take longer to fall asleep, sleep less, have less delta sleep, and have lower sleep efficiency than do normals, there also are well-documented cases of insomniac patients who fall asleep within 10-15 minutes and who sleep 7-8 hours per night. 1/-4/ Some insomniacs show greater variability in sleep measures from night to night than normal controls; it has been hypo- thesized that some of their suffering results from their inability to predict when they will have a good or bad night. 3/,5/ Among persons who do not complain of insomnia, some sleep very little and do not consider themselves to be insomniacs. One report describes two normal, healthy men who averaged about three hours of sleep per night when monitored nightly for seven days. 6/ Another describes the case of a 70-year-old woman whose typical 52 minutes of sleep per 24 hours was confirmed in the laboratory. 7/ She re- ported that she had been sleeping this way since her teens with no ill effects. *A comprehensive tabulation of the data upon which these conclusions are based is included in the Technical Supplement to this report. -81

extent study, sleep, On the other hand, insomnia patients tend to of their difficulties. In virtually every sleep laboratory insomniacs have had great difficulty in correctly assessing their although their subjective estimates usually vary in the same In a major sleep labor- latencv was overestimate the - direction as objective findings. 1/-3/, 8/-12/ atory study of 122 patients, for example, sleep latency was estimated by the patients to be 62 minutes, but was only 26 minutes by EEG crite- ~ - than two-fold. 1/ Actual total sleep time was 342 minutes, but estimated sleep time was 273 minutes, a difference of over an hour. In a classic case reported by Zung, a middle-aged woman with a 25 year history of insomnia slept for four nights in the sleep laboratory. 2/ She fell asleep quickly, slept over eight hours per night, and had normal architecture of sleep stages. Each morning, however, she reported that she "didn't sleep a wink." rota, an exaggeration ot more than two-fold. 1/ Figure 1 is a conceptualization of the overlap in objective ~ ~ ~ and patients with insomnia - to be significantly sleep measures in non-complaining controls complaints, in which the means have been found different between the two groups. Insomnia Mean Normal Mean - A// Normals it\\\>,: I nsomniacs Overlap LONGER AND MORE EFFICIENT SLEEP -82-

Studies suggest that many non-complaining middle-aged adults have sleep measures that have in the past been deemed impressive in insomniacs. Given the obvious heterogeneity of the insomnia population group, means and standard deviations of sleep measures can be very misleading. One must look at individual patients, rather than group data. For example, in one study referred to above, 58 (nearly half) of the 122 chronic insomniacs consistently fell asleep in less than 15 minutes, and many literally fell asleep instantaneously in spite of claiming they were unable to fall asleep the next morning. 1/, 12/ It is likely that the means conceal crucial diagnostic and etiological differences between patients who actually fall asleep promptly and patients who require several hours to fall asleep. Objective sleep measures alone have proven inadequate in understanding the causes of insomnia and providing confir- mation of ''effectiveness" for its relief. What accounts for insomnia complaints by patients whose objective measures of sleep seem to be adequate? -- Controls and insomniacs may differ in their thresholds for complaining of poor sleep. Given this framework, normal subjects are able to endure a certain amount of sleep fragmentation, sleep reduction, and so forth with no significant consequences. When some other dysphoria, such as anxiety or depression, is added to the picture, the threshold for sleep complaint may decrease. -- The discrepancies in many patients' data could be explained on the basis of fundamental differences in daily need for sleep. Thus, a 50 year old patient who sleeps 7.5 hours a night and complains of insomnia night be a person who requires 9.5 hours nightly to experience restora- tion and to maintain optimal alertness throughout the day. Such a question could probably be resolved by attempting to extend the total amount of sleep. But because very few individuals after the age of 50 are able to sleep for long periods of time without significant periods of wakefulness, the amount of time that such an individual might have to spend in bed in order to accumulate 9.5 hours of sleep could be be prohibitive. -- The classical sleep measures may not be the best way to assess adequacy of sleep. This is a controversial issue, because certain investigators feel that total sleep time is the only pertinent variable. It could be, however, that recently discovered factors such as EEG spindle or delta activity or measures of body movements will yield better clues to the restorative adequacy of sleep. -- Certain individuals may sleep at a higher level of physiological activation than other persons. 4/ Thus, some insomniacs who fall asleep in lo minutes and assume it is one hour may have such heightened activa- tion that they perceive themselves to be awake, however dimly, although they are really asleep. -83-

- Insomnia and the adequacy of nocturnal sleep may depend more on circadian rhythm properties than on the sleep measures themselves. It has been shown that there is a rhythm in sleepiness and fatigue, particularly in jet lag or in shift work, that can be fairly independent of amount of sleep and when sleep is taken. -- There could be an abnormally heightened response to partial sleep loss. If it is assumed that daytime sleepiness is a consequence of the reduction of sleep below some optimum, it is possible that this response in some people is manifested by exaggerated sleepiness from relatively minor sleep disturbance. -- The complaint of insomnia or disturbed sleep may not refer directly to sleep at all, but to an aspect of anxiety or depression. In these cases, the inability to sleep may become a relatively respectable, acceptable complaint. This formulation is supported by the work of Kales and associates 13/ who have reported Minnesota Multiphasic Personality Inventory (MMPI) studies in groups of patients complaining of insomnia and consistently find approximately 85 percent showing pathological elevation of one or more of the subscales. There is widespread feeling among researchers and clinicians that most complaints of insomnia are associated with depression and emotional problems. 14/ Issues of cause-and-effect and precise prevalence remain controversial and unresolved. The above observations illustrate some of the problems faced by the clinician. In treating a patient who complains, for example, that he requires an hour to fall sleep, the physician must remember (a) that it is likely that the patient falls asleep considerably more quickly, (b) that under the best of circumstances, a hypnotic will probably shorten the objective sleep latency by only 10 to 20 minutes; and (c) that although the patient's estimate of the difficulty may be exagger- ated, his subjective distress is real. At the present time, little is known about the relationship between the objective characteristics of sleep and subjective satisfaction. It is unclear why some people complain about their sleep when they sleep eight hours, while others do not when they sleep one hour. Nor is it known if hypnotics are more effective in insomniac patients with objective sleep disturbance than in those without. The functions of sleep are basically unknown. In terms of patient education, the physician should remember that some of the anxiety experienced by insomniac patients results from prior erroneous teach- ing about the functions of sleep. Everyone has heard that it is neces- sary to get "plenty of sleep" in order to maintain good health or to recover from illness. These common attitudes were reinforced to an -84-

unfortunate degree by early sleep laboratory experiments which prematurely suggested that deprivation of total sleep, REM sleep, or Stage 4 sleep might cause serious psychopathology. It now appears that the overall effects of REM sleep deprivation or Stage 4 deprivation are, at most, slight and subtle. There is little evidence that short term sleep deprivation increases the risk of mental or physical illness. However, epidemiological studies suggest that self-reported short 15/-16/ (and long) 16/ sleep may be related in the long run to increased mor- tality rates. It can be helpful for patients to be told that there are wide individual differences in the amount of sleep people seem to need. In a similar vein, current evidence suggests that the effect of a hypnotic drug on a specific sleep stage is not of major importance, and that choosing between hypnotics should not be based primarily on their relative effects on sleep stages. It seems reasonable to choose the drug with the least disruptive effect on sleep stages. All of the currently marketed prescription drugs appear, however, to alter sleep stages in one way or another. While flurazepam, for example, has a relatively small effect on REM sleep, it is a highly potent suppressor of Stage 3 and 4. On the other hand, the barbiturates, glutethimide, ethchlorvynol, the antihistamines, and the over-the-counter medications all tend to suppress REM sleep. The less potent hypnotics, such as L-tryptophan and chloral hydrate have the least effects on sleep stages-. One possible complication of REM suppressing drugs, however, should be considered. When these drugs are discontinued, total amounts of REM sleep on subsequent nights may increase dramatically for several days or weeks. This so-called "REM rebound" may be associated with vivid dreams or nightmares. Potentially, the REM rebound could be a period of special vulnerability in patients with nocturnal gastric hyperacidity, nocturnal angina, or other medical disorders which are intensified during REM sleep. "Drug withdrawal insomnia" or "rebound insomnia" has been identified following discontinuation of most REM- suppressing hypnotics and, recently, following discontinuation of some benzodiazepines, which mainly suppress Stages 3 and 4. The physician should keep in mind that sleep tends to become shorter, shallower, and more fragmented, with more awakenings each night, as part of the normal aging process. These tendencies are probably exaggerated in patients with insomnia, depression, or many other disturbing medical or environmental conditions. Because of the confusion engendered by the complaint (and concept) of insomnia, a closer look from the point of view of sleep research may be helpful. -85-

The Complaint of Being Unable to Fall Asleep (Sleep Latency Problem) Falling asleep quickly is an essential component of subjectively "good" sleep and is taken for granted by most people. A long delay in falling asleep is experienced as dysphoric. It is now known that sleep and wakefulness are part of a 24-hour rhythmic process, and there is a certain time of the day when the organism begins to experience a readi- ness for sleep. If the bedtime is not coordinated with this time, there could be a sleep latency problem. Because this fact is not generally understood, the sleep disorders specialist often finds that patients tend to be somewhat casual about the regularity of their bedtime - occasionally complaining of "insomnia" when they go to bed very early in the evening. Furthermore, there is very little data on what constitutes the threshold for complaining about this problem. Many complex factors can enter into a decision to seek medical advice: the actual number of nights the inability to fall asleep is experienced; the presumed etiology -- if the patient perceives an obvious cause he is less likely to complain than if the problem appears to have no cause; convenience -- thus, if one has a routine appointment with one's physician, one is likely to mention the perceived inability to fall asleep, whereas one may delay bringing the problem to the attention of the physician if a special effort is required to make an appointment; the effect on daytime activities -- a problem may be endured on vacation when there is a possi- bility of sleeping late in the morning, whereas if the same problem is felt to interfere with one's working situation, a physician might be consulted; finally, a patient's tendency to use medication pro- phylactically could be a factor. The Complaint of Being Unable to Stay Asleep (Sleep Maintenance Problem) Some people complain that they have no trouble falling asleep, but inevitably wake up during the night, either many times, or for a long period of time, or both. Once again, this type of complaint can be very complicated. Is there too much wine at dinner? A noisy environment? A strange bed? A bed-partner who snores loudly, moves frequently, etc.? Emotional upset -- especially depression? An inappropriate sleeping time? Here again the duration and intensity of the problem are issues. The Complaint of Daytime Consequences Although it is remotely possible in some patients that the total dysphoria of a sleep disturbance is the anxiety or boredom of lying awake at night, there is general agreement among sleep disorders specialists that a complaint of insomnia cannot be viewed as a sign of a pathological sleep disturbance unless there is some daytime conse- quence. However' when dealing with patients who complain of disturbed -86-

sleep, physicians may neglect to inquire about the effect of the pre- sumed sleep loss upon daytime function. Assessment of daytime problems consequent to nocturnal sleep dis- turbance is complex. It is well known that muscular activity can counteract sleepiness. _ / General pleasantness or unpleasantness of the life situation interacts, as do soporific situations like a hot room, a boring lecture, a heavy meal, use of alcohol, and so forth. Often a most difficult medical decision involves differentiating fatigue and tiredness due to sleep disturbance from alterations in mood and activity changes due to depression. B. Types of Insomnia Only in the past few years have a number of interdisciplinary cen- ters been established specifically to offer their services in the inten- sive evaluation of individual patients with sleep complaints. The aim with each patient is to make a specific etiologic diagnosis, and to recommend or initiate the most appropriate treatment. By compiling the results of individual cases, sleep disorders centers have thus begun the first comprehensive empirical case series analysis of the complaint of insomnia. In 1978, after nearly two years of deliberations and comparisons of case series, the Association of Sleep Disorders Centers (ASDC) proposed a standard diagnostic classification of "Disorders of Initiating and Maintaining Sleep" (DIMS). This is shown in Table 1, which also includes relevant parts of their classification of "Biological Rhythms Distur- bances" which may also give rise to the complaint of insomnia. This nosology undoubtedly will change as further progress is made in under- standing sleep disorders. In a few categories, data and experience were deficient and anecdotal information was utilized for the sake of com- prehensiveness. Several sleep disorders centers are now using this classification. Some diagnoses do not include a specific etiology, and in most instances no good data are available on treatment. However, the formulation of a standard classification is an essential prelude to further progress in cooperative case series studies and to more specific evaluation of the efficacy of hypnotic drugs and other therapeutic measures. The following is a description of most of the specific diagnoses, modified from the ASDC nosology to make the material useful to practicing physicians. Transient and Situational Insomnia Acute insomnia may arise from a number of sudden changes in life, such as medical, surgical, or traumatic conditions; admission to a -87-

Table 1 DIAGNOSTIC CLASSIFICATION OF INSOMNIA* I. Disorders of Initiating and Maintaining Sleep: DIMS (The Insomnias) 1. Psvehonhv~iolo~i c~1 a. Transient Situational b. Persistent 2. Psychiatric Disturbances associated with a. Personality and Neurotic Character Disorders b. Affective Disorders c. Acute Schizophrenia and Other Psychoses 3. Use of Drugs and Alcohol . associated with a. Tolerance to or Withdrawal from CNS Depressants b. Sustained Use of CNS Stimulants Sustained Use or Withdrawal of Other Drugs d-. Habitual Use or Withdrawal of Alcohol Sleep Induced Ventilatory Impairment . a. Sleep Apnea b. Hypoventilation Syndromes Nocturnal lIyoclonus and "Restless Legs" Syndromes - associated with a. Nocturnal Myoclonus b. "Restless Legs" Restless Legs with Nocturnal Myoclonus 6. associated with Other Medical, Toxic, and Environmental Conditions 7. Childhood Onset Centers *Adapted from the Nosology Committee, Association of Sleep Disorder -88-

Table 1 (continued) Other DIMS Conditions associated with a. Parasomnias (specify conditions) b. Repeated REDS Interruptions Atypical Polysomnographic Features Not Otherwise Specified 9. No DIMS Abnormality a. Short Sleeper ("Healthy Insomniac") b. Subjective DIMS Complaints without Objective Findings c. Not Otherwise Specified II. Dyssomnias Associated with Disruptions of 24-Hour Sleep-Wake Cycle 1. Phase Shift associated with a. Rapid Time Zone Change ("Jet Lag" Syndrome) b. Unconventional or Changing Sleep-Work Schedule (Shift Work) Delayed Sleep Phase 2. Non-24 Hour Sleep-Wake ~y~-~drome - 3. Irregular Sleep-Wake Pattern -89-

hospital or sleeping in any new environment; personal stress and anxiety, as in bereavement; or disturbances of biological rhythms, such as "jet lag" or shift work. Other commonly stressful conditions include occupa- tional changes, moving to a new location, severe illness in a close rela- tive or friend, termination of a romantic relationship, and test anxiety. Acute forms of insomnia usually respond to the passage of time, patient education, or the judicious use of hypnotics. However, firmly established treatments are lacking in some situations. In the case of jet lag, for example, administration of a hypnotic may increase total sleep time without improving subjective well being. 18/ In this condition, the actual loss of sleep is probably less disruptive than the deviation from the schedule imposed by one's internal biological clock. Insomnia Associated with Mental Disorders Psychological symptoms -- varying degrees of depression, anxiety, concern about physical well-being, and "nervousness" are common in insomniac patients. In a standard psychological screening test, such as the Minnesota Multi-Personality Inventory (MMPI), most insomniac patients show evidence of psychopathology, particularly on the depres- sion and hypochondriasis scales. 1/,13/,19/,20/ Before treating the patient, therefore, the physician must gauge the severity of the psychological disturbances, if any, and decide whether these distur- bances are sufficient to make a psychiatric diagnosis, such as depres- sion, mania, organic brain syndrome, alcoholism, drug addiction, schizophrenia, hypochondriasis, anxiety, neurosis, or personality disorder. This involves a careful history and mental status examina- tion, as well as additional history from relatives, friends and co-workers when appropriate. Not only do psychiatric illnesses fail to respond to hypnotics, but also hypnotics may be used by disturbed individuals for suicide. In one study, more than half of those who committed suicide by overdose had received a medical prescription for lethal amounts of a hypnotic within one week of death. 21/ A British study found that many patients who committed suicide by hypnotic ingestion had been taking sleeping pills for years, often renewing their prescriptions by telephone calls to the doctor's receptionist without any regular physician contact. 22/ Depressive illness may be classified as primary or secondary. Primary depression occurs in patients with primary affective illness, that is, in the absence of another primary psychiatric or medical illness. Primary affective illness includes unipolar (one or more depressive episodes) and bipolar depressive illness (a history of both depressive and manic episodes). Secondary depression may occur in patients with alcoholism, drug addiction, schizophrenia, obsessive- compulsive disorders, hysteria, passive dependent and pas sive-agressive disorders, and other psychiatric illnesses. It may also occur in patients with primary medical illnesses, such as Addison's Disease, hyperparathyroidism, or pancreatic carcinoma. —90—

In recognizing depression, the physician should be alert to the mental, physiological, and social symptoms seen in depressed patients (Table 2~. The duration of symptoms is important in establishing the diagnosis of a depressive illness since many of these same symptoms may occur briefly in acute situational reactions, such as mourning or severe disappointment. The physician's recognition of suicidal risk is of particular importance not only in patients with symptoms of depression, but also those who display signs of anxiety, irritability, hysteria, sociopathy, impulsiveness, alcoholism, or schizophrenia. As Murphy 23/ points out, the first and most important step is for the physician to ask himself "Can this patient commit suicide?" Once this is a consideration in the physician's mind, he should ask the patient several broad but tactful questions, such as "How has your mood been lately?" or "How badly have you been feeling?" He must ask specific questions about suicidal ideas, such as "Have you felt badly enough to wish you were dead?" "Have you ever thought of doing anything to yourself?" The patient with a specific suicide plan, and the means to carry it out, is at grave risk, and prompt hospitalization should be considered. Factors that increase risk of successful suicide include male sex, age greater than 40, social isola- tion, history of prior suicide attempts, delusions of somatic illness, troublesome physical illness, and uncontrolled drinking. 23/ Although men are more likely to successfully commit sucide than women, women are more likely to use drugs when they attempt or suceed in suicide. The prescription of sedatives or hypnotics in fatal doses to a suicidal patient may be a serious lapse of medical judgment. It implies, first, that the physician has failed to recognize the true diagnosis of depression and suicidal risk, and, secondly, that he has provided the patient with the means to kill himself. Since most hypnotics can be fatal when 10 to 30 dosage units are ingested, the amount prescribed in the modal prescription for hypnotics in this country -- 30 pills -- is sufficient to cause death or prolonged coma if taken in overdose. Even the benzodiazepines, which are rarely lethal when ingested alone, can be fatal when combined with alcohol or other drugs. Little justification exists for the general proposition that the suicidal patient will kill himself by some other means if denied the use of pills. This proposition may be true for a few patients; however, many are clearly ambivalent about dying and the suicidal attempt is often a "cry for help," impulsive or manipulative. Since generally effective treatments exist for depression, every effort should be made to recognize depression and suicidal risk and to treat it appropriately. Suffice it to say, treatment of depression is aimed at the reduction of depression and prevention of further episodes of affective illness. Among the important factors in treatment are -91- a

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good doctor-patient relationship and the appropriate combination of counseling, individual and family psychotherapy, anti-depressant medi- cation, and in severe cases, hospitalization. The tricyclic anti- depressants are often effective in relieving symptoms of unipolar depression, including the sleep disturbance. Anti-depressant medica- tions may also be helpful to patients with secondary depressions, but they seem to be less useful in patients whose depression appears to result from a clear precipitating event than those without such a history. Incidentally, the combination of barbiturates or other non- benzodiazepine hypnotics with tricyclic antidepressants is of dubious value in treating depressed patients, as these hypnotics will stimulate the microsomal enzymes of the liver, thus lowering blood levels of the tricyclic anti-depressants. Lithium salts have been found to be of particular benefit in the treatment and prevention of recurrent manic and depressive episodes in bipolar patients. It has recently been shown by Klerman and colleagues that although pharmacotherapy is useful in providing symptomatic relief for unipolar depressed patients (including fairly prompt relief of insomnia), psycho- therapy is more important in improving the patients' human relationships and social effectiveness. _ /,25/ Whether or not the primary care physician (or his or her paramedical associates) actually undertakes "psychotherapy" with a depressed patient, frequent telephone and personal contacts are essential. Without such follow-up, the patient may unwisely discontinue the antidepressant medication because of unimportant side effects, or the condition may worsen with the risk of suicide growing rapidly. As noted in Chapter 1, antidepressant drugs can be lethal in suicidal overdose with relatively few dosage units. Insomnia is occasionally a complaint in patients with schizophre- nia, toxic psychosis and delirium, and in chronic anxiety states manifested by recurrent nightmares (for example, traumatic war neurosis and the "concentration camp syndromes. In addition to psychosocial intervention, schizophrenic patients are usually treated with pheno- thiazines, butyrophenones, and other neuroleptics; the dose at bed- time may be increased if sleeplessness is a prominent problem. Patients with chronic anxiety states often require a combination of psychotherapy and judicious use of medications. Insomnia Associated with Drugs and Alcohol Pharmacologic factors must always be evaluated in the patient with insomnia. Dependence on, tolerance to, and withdrawal from hypnotic agents themselves may be major factors in the complaints of some insomniac patients. Some chronic insomniac patients receiving prolonged treatment with hypnotics appear to sleep worse than similar patients without hypnotic treatment. 26/ Some of these patients -93-

appear to improve once they have ended their dependence upon hypnotics. Because of psychological habituation and physical dependence on hypnotic agents, insomniac patients may experience worse insomnia when first discontinuing their sleeping pills even at conventional doses. When multiple doses have been taken, these drugs should be withdrawn slowly under medical supervision in view of the dangers of major withdrawal symptoms, including convulsions. Alcohol is a particular issue in insomnia, not only because alcoholics are at risk for suicide, but because it is probably the most commonly used self-medication for insomnia. In general, alcohol may produce prompt sleep, but it also often disrupts and fragments sleep. Though these drugs are often sought by alcoholics, sedatives, hypnotics and anxiolytics are thought by most authorities now to be both ineffective and hazardous in the long-term management of this condition. 27/ As mentioned previously, alcohol, taken in combination with various hypnotic agents, can readily produce toxic or even lethal effects. Furthermore, alcoholics often have markedly disturbed sleep patterns, persisting as long as two years after "drying out." 28/ Physicians should inquire about the use of other pharmacological agents, such as stimulants and caffeine. In addition, certain drugs such as reserpine or steroids may produce psychological depression which would interfere with sleep. - Sleep-Induced Ventilatory Impairment In evaluating the patient with insomnia, a number of disorders specifically related to sleep should be considered. Of particular importance is sleep apnea. 29/-32/ The administration of hypnotic drugs to patients with sleep apnea may be fatal. In this condition the individual is unable to breathe normally while asleep. After falling asleep, these patients develop episodes of apnea which last from a few seconds to~over 60 seconds and which are terminated with partial arousal and a few gasps for air. This sequence may be repeated hundreds of times each night without the patient's awareness that he has awakened so frequently. Three types of sleep apnea have been described. In central sleep apnea, the sleeping individual simply ceases any respiratory efforts at all, presumably because of some disturbance in the central regulation of respiration. In obstructive sleep apnea ? the patient continues to make the appropriate respiratory efforts (diaphragmatic and chest excursions) but is unable to inspire because of upper airway obstruc- tion and collapsed throat muscles. In the mixed form, both central and obstructive apneic episodes occur. Central sleep apnea is more -94-

likely than obstructive sleep apnea to be associated with the complaint of insomnia. Upper airway sleep apnea most commonly presents as a com- plaint of excessive daytime sleepiness, not insomnia. Patients who are found to have anneas that are predominantly central or mixed will fall asleep easily, but awaken many times during the night and feel tired and sleepy during the day. In fact, complaints of daytime sleepiness may overshadow the problems with sleep maintenance, leading to erroneous diagnoses like narcolepsy or depression. A careful history may elicit a report of notable snoring or even a description of snoring with intermittent pauses. Polysomnographic recording will show hundreds of repetitive apneas, initiated by the onset of sleep and terminated in each case by an arousal. The patient appears to breathe normally until sleep onset, at which time respiratory drive and effort stop, the diaphragm does not contract, there is no airflow, and oxygen desaturation occurs. The durations of the apneas are usually 30 seconds to several minutes. Cardiac asystoles may occur in association with respiratory pauses and pulmonary hypertension is frequently observed. The physician may obtain some clues to the diagnosis of sleep apnea by questioning the patient's bed partner, by asking the patient to obtain a tape recording of his respiratory sounds while asleep, and by personally observing the patient's sleep. Patients suspected of having this syndrome should be referred to a sleep disorders center for specialized evaluation, including polysomnography, which involves all-night recordings of the BEG, eye movements, electromyogram, electrocardiogram, heart rate, respiration, chest movements, blood gases, and other measures. Following the discovery of this syndrome in 1973, 31/ all patients with chronic insomnia referred to the Stanford University Sleep Disorders Center were routinely evaluated for sleep-related respiratory problems. This procedure gave rise to the first case series analysis of insomnia, which was completed in 1974 and showed 12 cases of insomnia with central sleep apnea in 100 chronic insomniacs.* . *Patients who reach sleep laboratories for specialized evaluations usually have had their problems for a long time and have unsuccessfully tried a number of remedies. It is not known how different they are from the overall population of insomniacs in general medical care settings. -95-

The case series was challenged by Bixler and associates who observed no cases of sleep apnea in 72 patients with insomnia. 33/ Nonetheless, several centers continued to evaluate respiratory functions in their patients and continued to find cases with central sleep apnea as the cause of insomnia. Hauri reported nine patients (6.4 percent) with sleep apnea in 141 consecutive insomniacs evaluated by polysomnography 34/ The Stanford case series continued to progress, and with approximately 300 insomniacs, showed that 27 patients (9 per- cent) had the etiology of a sleep apnea syndrome. Of special concern has been the apparently high prevalence in the elderly in both non- complaining controls and in those with unsatisfactory sleep. 35/ Most sleep disorders specialists now recognize the existence of sleep apnea syndromes as possible causes of unsatisfactory sleep in patients who have been referred to them for specialized evalua- tion. Yet to be established is the prevalence of these syndromes -- especially in insomnia patients in general medical practices, in the general population, and in the elderly. Treatment approaches to central sleep apnea are not well established. Obstructive elements in sleep apnea syndromes often can be remedied by naso-pharyngeal surgery or tracheostomy. Insomnia Associated with Nocturnal Myoclonus or Restless Legs Syndrome Nocturnal myoclonus is characterized by bilateral, fleeting muscular jerks usually of the anterior tibial muscles, occuring during sleep at intervals of about 20 to 40 seconds. 36/ These are often associated with secondary brief arousals. Hundreds of these events may occur over the night without the patient's awareness. The physi- cian can often get clues to the diagnosis by talking with the patientts bed partner. The diagnosis is confined by a polysomnogram with a simultaneous anterior tibial electromyog rem (EMG). Nocturnal myoclonus may occur in a variety of sleep disorders, including narcolepsy, sleep apnea, depression, drug dependence, and in normal subjects. Restless legs syndrome 37/ is closely associated with nocturnal myoclonus, but is characterized by an uncomfortable feeling in the thighs when the patient is resting. These feelings are relieved by ambulation (similar to akisthesia, a side effect associated with phenothiazines). The causes of these two disorders are not known, although restless legs syndrome can be associated with folate deficiency in pregnancy and with a variety of neuromuscular disorders. No well established treatment exists yet for either condition, although clorazepam has been reported to be useful in some patients. -96-

Insomnia Associated with Disruptions of the 24-hour Sleep-Wake Cycle Disturbances of basic biological rhythms may also produce insomnia. The phase-lag syndrome appears to be a true disorder which has recently been described. In this condition the patient is unable to fall asleep at the desired time, but can sleep readily and well at a later time. The major problem is that the patient sleeps through alarm clocks and is unable to get up or maintain normal vigilance during the morning hours at work or school. This syndrome is often associated with an altered circadian body temperature curve, suggesting that the patient is "out of phase" with the normal environment. Treatment consists of Desynchronizing the patient to the normal environment. If the patient is out of phase by four hours or more, this is usually best accomplished by advancing his bed time by two hours per day until he is gradually brought back into phase. The patient should be instructed to maintain a rigid schedule of bedtime and arising, thereafter. The "jet lag" syndrome is a transient disturbance that is the result of rapid time zone change. Although hypnotic drugs can induce sleep at the newly appropriate time, a return of sleepiness at the formerly customary time of day will still occur until the individual's biological clock has had time to re-adjust. 18/ Insomnia Associated with Medical Disorders Since insomnia may be associated with practically any medical or surgical condition, evaluation of the chronic insomniac patient must include a thorough medical history, physical examination, and appro- priate laboratory examinations. Insomnia is rarely the presenting chief complaint of a medical disorder, but it can be in such conditions as orthopnea, paroxysmal nocturnal dyspnea, dementia ("sun-downer syndrome"), and the like. Coexisting medical conditions and treatments must be considered while planning treatment for other types of insomnia. Hepatic or renal insufficiency, for example, may predispose certain patients to toxic reactions when taking hypnotics. When medical disorders appear to cause insomnia, treatment should be directed towards the medical condition rather than treating the sleep problem symptomatically. For example, a double blind, crossover study showed that indomethacin, an anti-inflammatory drug, was superior to amylobarbitone in promoting sleep in patients with rheumatoid arthritis; furthermore, the combination of indomethacin and amylo- barbitone was not superior to indomethacin alone. 38/ -97-

Other Conditions Associated with Insomnia Some patients have been described who appear to have suffered from insomnia since childhood, even infancy, independent of good and bad psychological periods. Small numbers of patients have been reported who have other disorders specifically associated with sleep: hyperactive gag reflex, REM sleep interruption insomnia, 39/ asystole during REM sleep in otherwise healthy adults (presenting as chest pain during sleep), 34/ gastro-esophageal reflux, or atypical or abnormal EEG wave forms. Examples of the latter include intrusions of alpha (waking) waves into non-REM sleep, excessive numbers of short arousals (15 seconds or less) during sleep, spindling activity during REM sleep, and so forth. These conditions have been described in patients studied by polysomnography, but further research is required to determine the clinical signifi- cance and prevalence of these conditions. Persistent Insomnia of Unknown Origin Finally, there is a group of patients who often have been called "primary insomniacs." The concept is controversial and is likely to change with future research. In most respects, this term coincides with the diagnosis of "persistent, psychophysiological disorder of initiating and maintaining sleep" in the nosology of the Association of Sleep Disorder Centers (Table l). For the present purpose, it refers to insomnia for which no major cause can be found at this time. Although these patients are often psychologically distressed, they do not meet the diagnostic criteria of a primary psychiatric illness. These patients often insist that insomnia is their main problem and that their subjective psychological distress is secondary to it. Some investigators, however, believe that psychosocial problems are still the main factor despite the patients' claims to the contrary. 13/ These chronic patients may constitute a sizeable proportion of those with insomnia. In a case series of 141 consecutive insomniacs studied in the sleep laboratory at Dartmouth Medical School, 51 (31 percent) were classified as "idiopathic" insomniacs. 40/ However, in a preliminary Stanford study using the new nosology, only four patients (10%) of 42 insomniacs were diagnosed as "DIMS (disorder of initiating and maintaining sleep), psychophysiological, persistent." Many persistent insomnias seem to be essentially learned habits of poor sleep. Two factors seem to play important roles: conditioning and internal arousal. In conditioned insomnia, the stimuli and rituals surrounding sleep -- bedroom, darkness, brushing teeth -- have preceded -98-

poor sleep so many times that they, themselves, can now trigger frustration and insomnia. In internal arousal insomnia, the mere act of desperately trying to relax and sleep causes increased arousal or tension, and leads to insomnia. Anxiety, either generalized throughout the day, or associated with the time of going to sleep, is almost always associated with persistent psychophysiological insomnia. However, for the insomnia to be classified here, this anxiety is neither severe enough to be classified as anxiety neurosis, nor is it associated with severe phobias, panic, or severe obsessive-compulsive symptoms during normal waking hours. In terms of recommendations that may be offered in office counseling, it is often useful for some patients to establish: (a) rigid times of going to bed and arising, (b) no naps, (c) the notion that the bed is a place for sleep (and sexual activity) but not for wakefulness, reading, eating, watching TV, worrying, letter writing, or any other activity, (d) the expectation that if the patient cannot go to sleep or cannot return to sleep upon awakening, he will get out of bed and occupy himself until he is ready to return to sleep; (e) a program of daytime exercise, which tends to promote nocturnal sleep; (f) evening activities conducive to relaxation, including hobbies, rest, hot baths, warm milk and so forth. As described in Section E of this chapter, some authorities recommend psychotherapy as a major part of the treatment approach to primary insomnia -- especially a directed, active form of therapy aimed at exploring underlying psychological and social factors which contribute to insomnia. Other behavioral measures such as self-manage- ment, biofeedback, and various relaxation approaches have also been advocated for these patients. Some physicians report that non-medical personnel for the physician's office (psychologists, social workers) can also be of great help in resolving acute and chronic psychosocial factors which contribute to the insomnia. 41/ No case series or con- trolled studies have as yet been reported, however, which establish the specific utility of these treatment approaches. Most sleep-disorder specialists do not recommend hypnotic drugs as the primary form of therapy in the treatment of most patients with persistent insomnia. At best, hypnotic therapy should probably be adjunctive and used only with careful physician monitoring over relatively short time periods. C. The "Sleep Disorder History" Although the classification and management of insomnia are still at early stages of development, much has been learned in recent years which is of direct importance to the practicing physician. Perhaps the most _99_

important principles are (1) to consider the differential diagnosis and- (2) to treat the specific underlying disorder whenever possible. In taking a sleep disorder history, the physician (or paramedical personnel on the health care team) should attempt to gather information in ten specific areas: 1. Falling asleep Does the patient have trouble falling sleep? It is desirable to know the usual bedtime and its regularity, how long does it usually take to fall asleep, and what are the usual events prior to turning out the lights. Where does the patient sleep and what are the conditions? Does he eat or exercise before bed? Does he drink? 2. Sleep maintenance The second question area has to do with sleep maintenance once asleep. The patient may describe sleeping for a time before waking up and being unable to return to sleep, multiple awakenings, or good undisturbed sleep. If possible, ascertain whether waking up is associated with bladder tension, dreams, feelings of anxiety or depression and so on. Ask about the usual times of the final awakening, of getting out of bed, their regularity. Does the patient awaken spontaneously or with assistance? Patients with primary depression are more likely than those with primary insomnia to suffer from early morning awakening. 42/ 3. Evolution How long has the problem been going on and what has its course been? Has the problem become worse, remained the same, or improved? What makes it better or worse? 4. Drug history It is extremely important to know if the patient is taking tranquilizers, hypnotics, marijuana, caffeine, stimulants, etc. -- acutely, chronically, and/or heavily. The physician should know the total medication history of the patient, particularly concurrent medications, including antidepressants, reserpine, steroids, cardio- vascular agents, and diuretics. 5. Daytime sleepiness/alertness Is the patient sleepy during the day? In normal subjects, moderate amounts of sleep loss will produce measurable daytime sleepiness. Patients may take naps. Chronic insomniacs tend to deny napping, though they often do take naps. Questioning should also be directed at a tendency for sleepiness to occur after meals, while driving, and at specific times during the day. Finally, how does the patient feel in the morning -- rested, groggy, disoriented, wide awake, depressed? 6. Emotional status Here the physician must make some decision about whether and to what extent the patient is anxious, depressed, sexually frustrated, suicidal, psychotic, manic, alcoholic or drug dependent. -100-

7. Snoring Many intercurrent conditions can affect breathing during sleep, such as bronchitis or allergies. If obstructive sleep apnea is suspected, it would be highly desirable to verify the snoring history by questioning a bed partner or by requesting a tape recording of respiratory sounds when the patient is asleep at home. 8. Body movements Is there a history of leg twitches during sleep, or restless legs? Restlessness at night can also be a sign of sleep apnea. Again, a bed partner may provide useful clues suggesting nocturnal myoclonus. 9. Gagging and choking through the night This can be related to gastroesophageal reflux or hyperactive gag reflex. 10. General health and demographics The patient's age, sex, general physical and mental health, and current treatments are all important considerations. D. Hypnotic Drug Therapy: An Overview This is an overview of choices for the physician who is consider- ing prescribing hypnotic drugs, and is followed by a section on non- pharmacological treatment approaches. More detailed information is provided in the Appendix. Neither the efficacy nor the safety of long term hypnotic drug therapy is established. Most sleep disorders specialists are dubious about its value and concerned about its risks. Leading authorities disagree or are uncertain about the indications for treatment with hypnotics, even in the short run. They also disagree about the classification of different subtypes of insomnia, and the relative prevalence of psychological causation, sleep apnea, nocturnal myoclonus, and so forth. Since insomnia has only recently been rigorously studied, and few case series have yet been accumulated, these problems are not unexpected. Hypnotics can probably be used safely and effectively in the short-term symptomatic management of transient insomnia in patients well known to the physician, who follows them during and after treatment. When faced with the clinical management of an insomniac patient, the physician must think diagnostically and treat underlying disorders whenever possible. If a hypnotic is chosen, one can be selected from four major types of medications: 1. Barbiturates -- the so-called short-to-intermediate acting agents such as pentobarbital, amobarbital, and secobarbital -- are often used as hypnotics. One of the advantages of these drugs is -101-

that they have long been used in medical practice and are well known. In general, they are effective in inducing and maintaining sleep on the first night of use and for several nights thereafter. Although hangover effects may occur, long-acting metabolites do not accumulate with repeated use. Among the disadvantages are that tolerance may develop quickly with regular nightly use (i.e., they lose their sleep-promoting properties), and in suicidal overdose, coma and death can occur at relatively low doses (10-20 dosage units). Interference with concurrent medications is also a problem. Withdrawal insomnia or nightmares may occur once the drug is stopped. z. Benzodiazepines of which flurazepam is the most widely used hypnotic in America, while nitrazepam is widely used in Europe. Diazepam and chlordiazepoxide, while not marketed as hypnotics, are also sometimes used. Unlike the barbiturates, the benzodiazepines (except for oxazepam and lorazepam) are converted to psychoactive metabolites with long half-lives. This has three important con- sequences: full clinical benefits are not seen on the first night of use, side effects increase in frequency and severity with nightly use, and clinical benefits and side effects may persist for several days once the drug is stopped. Withdrawal insomnia is not a mayor problem for flurazepam. Side effects are more likely in the elderly or in patients with renal insufficiency The most common adverse effects include daytime hangover, drowsiness, incoordination, and mental sluggishness. Skills related to driving may be impaired the next day. These agents have not been used in clinical practice long enough for a determination to be made as to whether severe conse- quences will develop when widely used in different populations or when used on a regular basis for long periods. Successful suicide is rare when these drugs are taken ad one, but does occur more com- monly when they are taken in combination with other CMS depressants such as alcohol or other hypnotics. 3. Nonbarbiturate, nonbenzodiazepine prescription hypnotics include choral hydrate, the oldest hypnotic in current use, which is notable for its lack of effects on respiration and blood pressure. Its therapeutic ratio in suicidal overdose is as poor as that of the barbiturates. Glutethimide does not appear to be a particularly effec- tive hypnotic in various comparative efficacy studies. It is, however, extremely toxic in the overdose situation, producing prolonged coma and more difficulties in resuscitation than other sleeping aids. Metha- qualone may be useful, although not strongly demonstrated yet in com- parison with other hypnotics. Its abuse potential is high, especially "on the street," because of its reputation as a euphoriant and aphrodisiac. Ethchlorvynol has only weak and short-lived effects on sleep in laboratory studies. Recently, it was reported to cause confusion and emotional distress the next day. Methyprylon appears to be a hypnotic which may be particularly useful because of its short half~life; it has not been studied adequately in sleep labora- tories. -102-

4. Other drugs used as sleeping aids include diphenhydramine, an antihistamine, which sometimes is used as a hypnotic. Other agents include neuroleptics (e.g., chlorpromazine, thioridazine) and anti- depressants (e.g., amitriptyline, doxepin) which may be administered either at night or during the day. The risk of tardive dyskinesia with persistent use of neuroleptics is a major concern; once it occurs, it is often irreversible. The anticholinergic properties of the so- called sedating antidepressants are significant and pose special problems for the elderly. Antidepressant drugs may also be used quite readily for suicide. L-tryptophan, an essential amino acid, appears to shorten sleep latency and promote total sleep, although its long term safety and efficacy is not yet established. Before prescribing hypnotics, the physician should be fully aware of some of the possible hazards (Table 3~. With the possible exceptions of flurazepam and nitrazepam, tolerance develops rapidly (within 1-2 weeks of nightly use) to all marketed hypnotics, that is, the hypnotics lose much of their pharmacological ability to induce and maintain sleep. In the case of flurazepam, only two studies have been published, each involving five insomniac patients who were studied for four weeks in the sleep laboratory while receiving the drug nightly; the drug appeared to retain many of its effects on sleep during these studies, but these data are obviously too limited to provide firm guidelines. Many of the other hypnotic hazards have been previously mentioned. Additionally, many hypnotics increase the arousal threshhold, which may make it difficult for the patient to awaken for a phone call or a fire alarm. 43/ The patient who has never taken hypnotics or who has used them only infrequently offers the physician the opportunity to conduct a thorough evaluation and to inform the patient about the potential risks of hypnotic medication before starting hypnotic therapy. Given the current lack of knowledge, it would appear medically prudent to use hypnotics sparingly and carefully, prescribing only a small of number pills at a time. The physician should be aware of long acting metabo- lites, which result from drugs such as flurazepam. If the full clinical potential of the drug is desired immediately, then it would seem wise to choose drugs such as diphenhydramine, methyprylon, diazepam, oxazepam, chloral hydrate or a barbiturate. In any case, strong encouragement should be given the patient to avoid the risk of depend- ing on drugs for sleep. Frequent patient follow up is important. As Clift has shown, such measures diminish the frequency of the development of nightly reliance on drugs for sleep. 44/ The patient who already has been taking hypnotics regularly for a long period of time poses a special problem. The first issue is whether this practice is effective and safe for this particular patient. -103-

TABLE 3 POSSIBLE HAZARDS AND LIMITATIONS OF USE OF HYPNOTICS 1. Overdose toxicity 2. Additive toxicity with alcohol and other CNS depressants Adverse interactions with other prescribed drugs (oral anticoagulants, tricyclic antidepressants, anticholinergics) "Hangover" skills effects on daytime coordination, cognition, mood, driving 5. Confusion, ataxia and other adverse effects in the elderly 6. Adverse reactions in medical patients with hepatic, renal or respiratory insufficiency 7. Potentially lethal effects in sleep apnea 8. Possible teratogenic and carcinogenic effects on offspring when taken in pregnancy S. Difficulty awakening from sleep to respond to fire alarms, crying baby, and the like 10. Development of nightly reliance on drugs for sleep 11. Possible exacerbation of insomnia 12. Development of tolerance 13. Disruption of normal sleep stages 14. Liability for use in drug abuse (intoxication, addiction) —104—

If the patient still complains of insomnia, the physician should carefully reevaluate, particularly for the possibility of misdiagnosis, drug-related insomnia, and toxicity. Complete drug withdrawal may be helpful but should be pursued cautiously with due concern for depend- ence, tolerance, habituation, and "drug-withrawal" or "rebound" insomnia. Particularly severe cases may be referred to a sleep disorders clinic. Long time users of hypnotics who are satisfied pose different problems. They may be dependent and unable to discontinue because of psychic and physical dependence. They may be placebo responders. Many physicians in this situation apparently decide to let "sleeping dogs lie." It should be clear, however, that the scientific basis for long term administration of hypnotics is not established. The physician should monitor such patients closely and should not renew prescriptions without proper re-evaluations. E. Non-Pharmacological Therapies for Insomnia Office Counseling In their response to a questionnaire, 26 practicing primary care physicians (internists, family practitioners) who are members of the Institute of Medicine, indicated confidence in office counseling as part of an effective treatment approach toward many problems of insomnia. The content of such counseling efforts, naturally, would vary with the diagnostic evaluation of any associated difficulties (depression, situational stress, alcohol abuse, physical discomfort). In a discussion with staff and steering committee members for this study, the Institute members said that a good doctor-patient relation- ship often made it possible to refuse patients' requests for sleeping medication when these seemed inappropriate or excessive without alienating the patients. Many patients could indeed be "educated" along the lines described in previous sections of this chapter. Primary care physicians do not receive payment for much of the time spent in office counseling. Explorations should be made of greater utilization of paramedical personnel for this purpose (nurses, social workers, physician's assistants) and possibili- ties of third party payment for time physicians spend talking with patients. Psychotherapy The primary care physicians varied in their general willingness to refer patients to mental health specialists for formal psycho- therapy and/or specialized pharmacotherapy. The patients most likely -105-

to be referred were either those who expressed suicide]. intent, or those whose own psychological sophistication was already quite high. Even for patients without an obvious mental disorder, Kales and colleagues have advocated dynamic psychotherapy as part of a multi-modal treatment approach to chronic insomnia. 45/,46/ Although the patients may be preoccupied with the "bodily symptom" of insomnia, Kales has found that their hidden emotional distress wi].1 often respond to psychotherapy that focuses on personal issues unrelated to sleep. A a limited period of hypnotic medication and some behavioral. techniques directed at sleep habits also may be emp].oyed. Neither a substantial case series nor a comparative study have yet been published, so the specific utility of this approach cannot be evaluated. The psychotherapeutic and psychoana].ytic approaches advocated by Hartmann for certain kinds of patients have also not been evaluated for their impact on insomnia symptoms, but his description of "the psychodynamics of the sleeping pill" is an interesting review of the personal meanings that may be attached to drug-taking behavior at bedtime. _ / Behavioral Therapy Behavioral therapies are a heterogeneous group of treatment modalities whose common theme is the modification of objective and measurable behaviors in contrast to dynamically oriented psycho- therapies, which focus primarily on the patient's relationships and inner feelings. Behaviora]. therapies are ].argely derived from learning theories developed in the experimental psychology laboratory. They have been employed in the treatment of anxiety, phobias, overeating, and smoking. As applied to insomnia, several different approaches have been employed, with varying degrees of success. Probably the most widely studied behavioral methods for treating insomnia employ techniques to enhance re].axation at bedtime. Among the most popular methods have been electromyographic (EMG) biofeedback, progressive relaxation and autogenic training. EMG biofeedback is performed by electronically measuring the tension in a muscle group (usually on the forehead) and transducing this to a tone of varying pitch. The subject learns to maximize the production of the pitch that indicates decreased muscle tension. Progressive relaxation, derived from the work of Jacobson, 48/ entails a series of exercises in which the subject tenses and then relaxes individual. muscle groups. In autogenic training the subject concentrates on standard phrases that emphasize a feeling of heaviness and relaxation in different parts of the body. 49/ -106-

Studies using these methods to treat insomnia have had mixed results. Earlier papers, often case reports or uncontrolled patient series, suggested that the methods might be promising. 50/-53/ Among studies that controlled for subject expectation and similar factors are those of Borkovec and Fowles, 54/ who found that progressive relaxation was of some benefit in questionnaire-selected college students, but that improvement was no greater than in a self-relaxation group, and that of Nicassio and Bootzin, 55/ which was more hopeful about the benefits of progressive relaxation and autogenic training in volunteers who reported long sleep latencies. More recent studies have added EEG measures of sleep onset latency to the experimental protocols. Borkovec and Weerts 56/ studied college students reporting sleep problems under three treatment conditions: 1) Jacobsonian relaxation therapy, 2) placebo (quasi-desensitization), and 3) no-treatment controls. The sleep recording findings showed a significant reduction of measured sleep latency in the group who received relaxation training. All three groups showed an improvement in self-reported sleep latency. Freedman, et. al, 57/ combined the results from three labora- tories _ /-60/ of studies that employed subjects with clinical insomnia (not just "poor sleepers" derived from college classroom questionnaires, which have often been used in studies in this area), had control groups, and reported sleep EEG data as endpoints. Data were combined into three treatment modalities: 1) biofeedback (two types); 2) other relaxation procedures (progressive relaxation and autogenic training); and 3) control groups (mild exercise and electro-sleep). Statistical analysis showed no significant pre- or post-treatment differences between groups. At this time, there is little basis to suggest that these methods are beneficial in the treatment of insomnia. Another behavioral approach to the treatment of insomnia is the use of systematic desensitization. In this technique the patient is taught relaxation exercises, and is then requested to visualize scenes related to going to bed while in a relaxed state. The goal of such an approach is to associate bedtime with a sense of relaxation, which is incompatible with the anxiety that otherwise might be interfering with sleep. Case reports 61/ and uncontrolled studies 62/ have been enthu- siastic. Steinmark and Borkovec 63/ compared an applied relaxation treatment and desensitization-plus-relaxation with two control groups (a quasi-desensitization procedure and untreated patients). Subjects were college students who stated on a questionnaire that it took them longer than 30 minutes to fall asleep. The two treatments were equally effective and better than the two control procedures in reducing subjective sleep latency, even in the face of a counterdemand suggestion -107-

that the treatment would probably be of no benefit for about four weeks. However, the group receiving relaxation training alone also improved, so the specificity of the desensitization aspects of the treatment is in question. Classical conditioning procedures have been described as useful in the Russian 64/ and German 65/ literature. One example 66/ of this approach was the administration of methohexital to induce sleep in a patient with anxiety, phobias, and hyposomnia while he listened to a metronome. The patient would then turn on the metronome at bedtime. Although this procedure was clinically beneficial in this and another case, 67/ there are no data from controlled studies. Stimulus control studies of insomnia are based on the proposition that the insomniac has difficulty because the bedroom environment has become associated with activities incompatible with sleep (worrying, eating, watching television). The patient is instructed to get into bed only when sleepy, and to immediately leave the bedroom if he finds himself engaged in any activity except sleep or sex. A com- parison of stimulus control, progressive relaxation, self-relaxation and no treatment in 78 subjects disclosed the greatest reduction in subjective sleep latencies in the stimulus control group, followed by the progressive relaxation group; and these were both signifi- cantly better than the other two groups. _ / This approach has fared well in subsequent studies, _ /-70/ and might profitably be examined further in controlled studies of insomniacs. Attributional therapy is based on the concept that manipulation of a subject's understanding of the source of his difficulty might be therapeutic. In an effort to externalize the perceived source of arousal, 71/ when patients were told that a pill they were receiving would further stimulate them, they went to sleep more quickly. Other subjects who were told that a pill was a sedative stayed awake longer, presumably because they became distressed that they were having difficulty falling asleep even when taking a "sedative," and the resultant anxiety compounded the sleep disturbance. This notion has suffered in replication studies, however, and is unproved. 72/-73/ In another variation on attribution therapy, it was suggested that an insomniac's sleep may improve if he can learn to attribute to himself the ability to go to sleep easily. 74/ Insomniacs received a combination treatment that included a high dose of chloral hydrate (1000 mg), relaxation training, and practical suggestions such as regularizing their sleep habits. Those who improved were divided into two groups. One group was told that the dosage they received was maximally effective and hence the implication was that their -108-

improvement was due to the medication. The other group was told that their dosage was only minimally effective, and hence that their improve- ment was due to their own efforts. The chloral hydrate was then discontinued, and it was found that the latter group continued to do well, while the former group became worse. One case report suggests the possibility that self-monitoring, in lieu of any behavioral training techniques, may be an effective treatment in certain patients complaining of insomnia. 75/ The case report showed dramatic improvement in one patient who was simply asked to keep daily records of his sleep latency, the time he awoke, and the amount of time he spent napping. Again, however, specific replica- tion studies have not been reported. insomnia . Behavioral self-management emphasizes a combination of specific techniques, such as progressive relaxation and a cognitive learning theory approach. 76/ 77/ With the latter the patient is asked to keep diaries and to explore and decrease the stimuli which raise the anxiety-tension level in the daytime. Modification of work and domestic schedules is used to decrease anxiety producing stimuli in the evening. Specific internal arousal conditioning factors such as internal dialogues after lights out, are discovered and dealt with. All the techniques emphasize mastery and aid the patient to overcome a sense of impotence in dealing with his sleep problem. ~ ~ ~ incorporated in the treatment regimen for in- These techniques somniacs seen at are the Stress Reduction Clinic at the Stanford Medical Center. Successful results have been described in individual cases (including some who had been drug dependent) using this multi-faceted treatment, though a case series and controlled studies are needed to establish the usefulness of this approach. -109-

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11 12 13 14 15 16 17 18 19 20 Carskadon, M., Mitler, M., Billiard, M., Phillips, R. and Dement, W A comparison of insomniacs and normals: Total sleep time and sleep latency. Sleep Research 4:212, 1975. Scherer, M. and Dement, W.C., Personal communication. ., Kales, A., Caldwell, A.B., Preston, T.A., Healey, J. and Kales, J.D., Personality patterns in insomnia. Archives of General Psychiatry 33: 1128-1134, 1976. Hartmann, E., The Sleeping Pill (New Haven: Yale University Press), 1978. Belloc, N.B., Relationship of health practices and mortality. Preventive Medicine 2:67-81, 1973. Kripke, DeFe ~ Simons, R.M., Garfinkel, L. and Hammond, E.C., Sleep duration, insomnia and sleeping pill use e Archives of General Psychiatry 36:103-116, 1979. Kleitman, N., Sleep and Wakefulness (Chicago: University of Chicago Press), 1963. Pollack, C.P., McGregor, P., Weitzman, E.D., The effect of flurazepam on daytime sleep after acute-wake cycle reversal. Sleep Research 4: 112, 1975. Coursey, R.D., Buschsdaum, M. and Frankel, B.L., Personality measures and evoked responses in chronic insomniacs. Journal of Abnormal Psychology 84:239-249, 1975. Roth, T. and Kramer, M., The nature of insomnia: a descriptive sum~ary of sleep clinic population (abstract) in Sleep Research 4: 234, 1975. —111—

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62 63 64 65 66 67 68 69 70 71 Hinkle, J.E. and Lutker, E.R., Insomnia: A new approach. Psycho- therapy: Theory, Research and Practice 9:236-237, 1972. Steinmark, S.W. and Borkovec, T.D., Active and placebo treatment effects of moderate insomnia under counterdemand and positive demand instructions. Journal of Abnormal Psychology 83:157-163, 1974. Beilin, P.E., an attempt at organize medical treatment by condi- tioned reflex sleep in the Markarov Hospital. Klin. Med. Wein. 9 50-58, 1952. Marchand, H., Ueber die Herbeifuehrung des bedingt - reflektoritschen schlafes ohne medikamente. Dte. Gesundhives. 9: 1255-1266, 1954. Scotton, L., The classical condition of sleep and wakefulness Behavioral Research and Therapy 3:259-264, 1965. Evans, D. and Bond, I., Reciprocal inhibition therapy and classical conditioning in the treatment of insomnia. Behavioral Research and Therapy 7:315-316, 1969. Bootzin, R.R., Stimulus Control of Insomnia. Paper presented at the Meeting of the American Psychological Association. Montreal, 1973. Tokarz, P. and Lawrence, P.S., An Analysis of Temporal and Stimulus Factors in the Treatment of Insomnia. Paper presented at the 8th Annual Meeting of the Association for the Advancement of Behavioral Therapy, Chicago, 1974. Haynes, S.N., Price, M.G., and Simons, T.B., Stimulus control treatment of insomnia. Journal of Behavior Therapy and Experimental Psychiatry 6:279-282, 1975. Storms, M.D. and Nisbett, R.E., Insomnia and the attribution process. Journal of Personality and Social Psychology 16: 319-328, 1970. -116-

72 73 74 75 76 77 Kellogg, R. and Baron, R.S., Attribution theory, insomnia and the reverse placebo effect: A reversal of Storms and Nisbett's findings. Journal of Personality and Social Psychology 32:231-236, 1975. Bootzin, R.R., Herman, C.P., and Nicassio, P., The power of suggestion: another examination of misattribution and insomnia, Journal of Personality and Social Psychology 34:673-679, 1976. Davison, G.C., Tusjimoto, R.N., and Glaros, A., Attribution and the maintenance of behavior change in falling asleep, Journal of Abnormal Psychology 82:124-133, 1973. Jason, L., Rapid improvement in insomnia following self-monitoring. Journal of Behavior Therapy and Experimental Psychiatry 6:349-350, 1975. Coates, T.J. and Thoresen, _ Program for Overcoming Insomnia. (Englewood Cliffs, N.J.: Prentice Hall), pp. 1-324, 1977. .E., How to Sleep Better: A Drug Free Thoresen, C.E., Coates, T.J., Kermil-Gray, K. and Rosekind, M.R., Treating Insomnia: A Self-Management Approach. Sleep Research Vol. 7 (in press) -117-

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