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Chapter 2 EPIDEMIOLOGY OF SLEEP COMPLAINTS AND PRESCRIBING PRACTICES A. Prevalence of Sleep Complaints Insomnia -- unsatisfactory sleep — is the major symptom for which the drugs discussed in this report are prescribed. Surveys of the general public show that interpretations of the word "insomnia" vary. A telephone survey conducted by the Stanford University Sleep Disorders Center showed that 38 percent of 6, 352 respondents claimed to have a sleep problem.* Of the 2, 400 people with complaints, 467 or 20 percent had sought assistance from a doctor. Despite these responses, however, only four percent felt they had insomnia. Surveys intended to measure the prevalence of sleep complaints are difficult to compare because of the ambiguity of the word insomnia, and the variation in survey formats, population types studied, sample designs, and the methods of administration. Nevertheless, the surveys show some consistent patterns that allow tentative conclusions to be drawn about the prevalence of sleep disturbance and the use of medication to alleviate this complaint. In a non-random survey of more than a million people, 13 percent of men and 26 percent of women over age 30 complained of insomnia. The incidence of the complaint in men remained stable until age 80 when it increased to more than 16 percent. In women, the incidence increased to about 31 percent at age 55 and remained stable there- af ter . _/ A survey in Great Britain of more than 2, 400 subj ec ts aged 15 to 75 and over, found that eight percent reported sleeping less than five hours each night. Difficulty in falling asleep was found in 5 to 10 percent of male subj ects and in 5 to 30 percent of females, with a clear relationship to age. Thirty-five percent of the group reported frequent nocturnal arousals, and morning tiredness was noted by 25 percent. 2/ *Subj ects were asked: ''Do you have a hard time falling asleep? Do you awaken during the night and have trouble getting back to sleep? Do you awaken too early in the morning and have trouble getting back to sleep? Do you feel tired because you can't sleep?" —47—

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In a 1970-1971 national probability sample survey of the United States population, 11 percent of the men and 17 percent of the women interviewed (14 percent of the total sample) reported a "lot of trouble" getting to sleep or staying asleep, and were judged to have a major problem in this regard. An additional 19 percent of the total sample was judged to have a minor problem with sleep. 3/ The Los Angeles Metropolitan Area Survey of 1,000 adults found that 32 percent of the sample currently complained of difficulty falling asleep, staying asleep or awakening too early, and the incidence of such complaints increased with age. 4/ Recently, the same investigators reported findings from a survey of 4,451 physicians who estimated that 17 percent of their patients complained of insomnia, and that 55 percent of these were given hypnotics. 5/ In a 1969-1970 study of 1,645 adults, 22 percent "sometimes" had trouble getting to sleep or staying asleep during the night, and 13 percent "often" had such problems. Positive responses were found to be higher for females, and increased with age. Seven percent of the study sample reported using sleeping pills "sometimes" and another 3 percent said they used pills "often" or "all the time." Pill taking was twice as high for whites as for blacks, "higher" for females, and increased "markedly" with age. The kind of pills used were not speci- fied. 6/ If asked, then, about one-third of the adult population in the United States, or about 50 million people, would report some sleep disturbance in any given year. Most would not consider their complaint to constitute insomnia. Only 15 to 20 percent of those reporting any sleep problem, or six percent of the adult population, would bring it to the attention of a physician, who would prescribe a sleeping pill for about half of them. B. Trends in Prescribing Medication for Sleep In 1977, about four and one-half million prescriptions were written for barbiturate hypnotics, compared to 21 million for non- barbiturate hypnotics; this does not include medication given in hospitals. Although the prescribing of all hypnotics has decreased 39 percent since 1971, barbiturate hypnotic prescriptions declined 77 percent during the period 1971 to 1977 (Table 1~. Undoubtedly, the introduction of flurazepam to the market in 1970 was a major influence on these trends. The rapid acceptance of fluraze- pam as an alternative to barbiturates and to the leading non-barbiturate hypnotic at that time glutethimide was striking. In just seven years, prescriptions for flurazepam have increased to account for 53 -48-

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percent of all hypnotic prescribing in 1977, while the barbiturates declined from 47 percent in 1971 to 17 percent in 1977. The reschedul- ing of the hypnotic barbiturates to Schedule II of the Controlled Substances Act in 1973* was followed in 1974 by a 54 percent drop in the number of prescriptions written for these drugs, and there has been a continuing decline since. Figure 1 traces prescribing trends since 1964. It has been suggested that increasing use of anti-anxiety drugs and anti-depressants for sleep may account for part of the overall decline in use of hypnotics. Trend data on "desired action" by physi- cians who prescribe these drugs are not readily available to test this assertion. Prescriptions for anti-depressants increased from 23 million in 1971 to almost 30 million in 1977; in 1977, about five percent were written "to promote sleep.'" Among the anti-anxiety drugs, prescriptions increased by one percent from 1971 to 1977, from 89 million in 1971 to 90 million in 1977, after peaking; in 1975 at 103 mills on prescriptions. Prescrip- tions for the leading tranquilizer, diazepam, increased from 41 million in 1971 to 62 million in 1975 but declined by 8 million to 54 million in 1977. During this period, prescriptions for chlordiazepoxide and meprobamate declined steadily from 25 million to 13 million and from 16 million to 8 million prescriptions, respectively, and prescriptions for the barbiturate (daytime) sedatives decreased by 42 percent from about 20 million to 12 million. There does not appear to be any compensating increase in the overall prescribing of anti-anxiety drugs that could account for the decline in hypnotic prescriptions, but rather a substitution of the benzodiazepine, diazepam, for the older daytime sedatives and tran- quilizers. It may be that physicians are prescribing hypnotics less frequently and more selectively than a few years ago. Two other possi- ble explanations are that people receiving prescriptions for hypnotics could be using them intermittently thus making a single prescription last longer; or that the sleep-inducing properties of diazepam are more potent than those of the older drugs and that physicians make use of this fact by instructing patients to take one dose close to bedtime. Anecdotally, a group of Institute of Medicine members who are primary care physicians estimated that no less than 20 percent of patients using diazepam do so in this way, on their own initiative. - *Thereafter, prescriptions for secobarbital, pentobarbital, and amobarbital could not be refilled without a new written prescription. The same restriction was applied also to methaqualone. -50-

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40 35 o . _ ._ Cat ._ - cn 30 J - IL UJ Or ~ 25 En a: an of OF 20 LL LL o CC lL m 10 He _' .~ - O - - ~ _ All Hypnotics Barbiturate Hypnotics - \ ~ . — \ at, All Non-Barbiturate Hypnotics Flurazepam Non-Barbiturate Hypnotics (excluding flurazepam) 1 1 1 1 1 _. - .. I I I I I J I\. - - - - - - - - - 1 965 1967 1 969 1 971 1 973a 1 975 1 977 YEAR Source: National Prescription Audit, INS America, Ambler, Pa. a1973 Amendments to the Food, Drug, and Cosmetics Act—Barbiturate Hypnotics and Methaqualone moved to Schedule 11. —51—

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Drugs other than hypnotics are, however, prescribed specifically to aid sleep. Anti-anxiety drugs such as diazepam and chlordiazepoxide are prescribed for sleep about three percent of the time. 7/* About two percent of the presciptions written for the anti-histamine, diphen- hydramine are for sleep, and two percent of barbiturate sedatives are for this purpose. This results in an additional five million prescriptions of non-hypnotic drugs prescribed specifically to aid sleep. C. The Physician's Diagnostic and Therapeutic Responses In 1978, there were almost one and one-half million visits to physicians in which the patient's primary complaint related to a sleep problem, including too much sleep (hypersomnia) and too little sleep (insomnia). These visits represented less than 0.3 percent of all office visits. 8/ However, in 78 percent of outpatient instances where a hypnotic is prescribed as new therapy, the primary diagnosis is other than a sleep problem, although disturbed sleep may be one of the symptoms of or a result of this condition. In 19 percent of instances, the primary diagnosis is likely to be a mental disorder, particularly neurotic depressive reaction or anxiety reaction. Circulatory disorders, arthritic conditions, and respiratory ailments, which may be expected to produce physical discomfort or pain sufficient to disrupt sleep account for a further 25 percent of cases (Table 2~. To expand the data base of this study, 49 Institute of Medicine members who identified themselves as medical practitioners were asked to complete a questionnaire designed to elicit patterns of prescribing *Data from the National Disease and Therapeutic Index (NDTI), (c) copyright ITS America Ltd., 1977. The data are collected monthly from a panel of 525 doctors selected to provide a representative sample of practicing physicians. Each physician is asked to report four times a year on a 48-hour period of practice. Reporting is scheduled so that every day of the year is covered by the sample. For each 48-hour period, the physician completes a patient record form for each private patient attended to, whether in the office, in the hospital, by telephone or in the patient's home. In addition to patient's age and sex, data recorded include the physician's diagnosis, the therapy provided, whether or not this therapy is new or continuing for the particular diagnosis, and whether or not this is the first or a subsequent visit for the diagnosis. If a drug is prescribed, the name of the drug is reported. The data presented here represent only physician office practice since hospitals, outpatient clinics, community health centers and other clinics are not included in the sample. For purposes of this report, the NDTI data include only reports for patients seen in the physician's private office, in the patient's home or contacted by the telephone. -52-

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barbiturates and other hypnotics, and to determine factors that contribute to the decision to prescribe a particular drug; 34 members responded including 26 internists and family practitioners. These physicians averaged 24 years in practice. The typical respondent felt that 70 to 75 percent of sleep complaints were attributable to some psychological cause, with the remainder due to some diagnosable medical illness. They estimated that about 12 percent of patients coming to see them over a two week period would complain of sleep disturbance, either as a primary complaint or secondary to some other problem. In a 1968 British study of patients taking hypnotics, it was found that the original indication in 49 percent of cases had been a medical condition; in 31 percent, a psychiatric illness; and in 20 percent, the problem was sleep onset insomnia, due largely to situa- tional anxieties. The authors point out, however, that half the patients with a medical disorder manifested anxious personality traits and that hypnotics are often prescribed to alleviate the anxiety that accompanies the pain or physical discomfort of a medical disorder. 9/ Few data are available about the relationship between a specific sleep complaint and the therapy prescribed. Even when a hypnotic is prescribed, sleep is not always the goal. In 1977, for example, although 73 percent of new therapy with barbiturate hypnotics was primarily for sleep, 14 percent of the prescriptions were for daytime sedation. The non-barbiturate hypnotics were more likely to be prescribed solely for sleep (Table 3~. In 1977, about one-third of all office visits were made to family and general practitioners who, as one might expect, wrote the largest proportion -- 34 percent -- of prescriptions for hypnotics. They were followed by psychiatrists with 23 percent, and internists with 15 percent (Table 4~. The class of hypnotic and the pattern of prescribing varied among the specialties. The barbiturates were more likely to be prescribed by the family physician and the internist than by the psychiatrist. For new therapy, office-based psychiatrists appear to have abandoned barbiturates. Psychiatrists were responsible for the largest propor- tion of continuing hypnotic therapy, most of which was with fluraze- pam. Thirty-nine percent of all prescriptions written for hypnotics in 1977 were for people over 60, who comprise 15 percent of the population and account for approximately 11 percent of office visits (Table 5~. More than half the barbiturate prescribing in office-based practice was for this group, most of it a continuation of therapy. -54-

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Table 3. Ambulatory Prescribing of Hypnotics by Desired action, Drug Class and Therapy a/ Drug Class and Therapy Desired Action Total New Continuing % ~ % b/ Barbiturate Hypnotics 100 100 100 Sleep 70 73 68 Daytime sedation 13 14 14 Pain relief 1 1 Antihypertension 2 7 1 No reason given 14 6 15 Non-Barbiturates 100 100 100 Sleep 75 74 80 Daytime sedation 2 3 2 Pain relief 1 1 1 Antihypertension * * * No reason given 22 23 17 All Hypnotics 100 100 100 Sleep 73 73 76 Daytime sedation 5 5 6 Pain relief 1 1 1 Antihypertension 1 1 * No reason given 20 20 16 Source: National Disease and Therapeutic Index, INS America Ltd., Ambler Pennsylvania *Less than 0.05 percent , ~ . . . . a/ therapy Indicates whether this is the initial prescription of a given drug or continuing therapy for a particular diagnosis for a particular patient. b/ Drugs containing secobarbital, pentobarbital and amobarbital; not phenobarbital or butabarbital. -55-

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D. Hospital Use of Hypnotic Drugs Each year in the United States there are about 33 million admissions to short-term general hospitals, with an average stay of about eight days. 10/ Although national statistics are not available, indications are that about half of all patients hospitalized in the United States receive a hypnotic drug at some point during their hospital stay. For example, one study reports that 58 percent of 4,177 patients at three Boston hospitals received one of the four most commonly used hypnotic drugs in these hospitals. 11/ Data from Veterans Administration hospi- tals show similar trends. At the Durham, North Carolina, Veterans Admin- istration Hospital, 66-92 percent of the patients had prescriptions for hypnotic drugs while 41 to 54 percent of medical and surgical patients actually received hypnotic drugs. 12/ Similarly, in a 1973 study of the San Diego Veterans Administration Hospital, 57 percent of patients had orders for hypnotic drugs and 30 percent of patients actually received a hypnotic on a single night. The Veterans Administration purchases approximately one hypnotic dosage per occupied inpatient bed per day, not counting sedatives like diazepam, chlordiazepoxide, or phenobarbital. 13/ Data are not available about the indications considered in physician prescribing of hypnotics for hospital patients, or the types of patients and illnesses that stimulate such prescribing. Often, this widespread use of hypnotics in the hospital is dismissed as being of small concern since the patients use the medication directly under the supervision of health care personnel. Moreover, the total volume of hypnotic drugs dispensed in hospitals is only one-ninth that pre- scribed for ambulatory patients. 14/ However, it is in the hospital that physicians receive their clinical training, and the casual prescribing of hypnotics in this environment may be expected to influence their future use of these drugs. E. The Population's Use of Hypnotics A national survey in 1971 estimated that about three percent of the population between 18 and 74 had used a hypnotic drug in the preceding year. Since about 20 percent of hypnotic drugs are prescribed for people over 74, adjustment would raise this rate for the total population over 18 to about four percent. 3/ A survey conducted in 1972 estimated that 11 percent of the populaton over 18 had used a sedative (defined to include both hypnotics and the barbiturate sedatives phenobarbital and butabarbital) for medical purposes during the year. 15/ A repeat survey conducted in 1977 estimated that almost nine percent of the population had used these hypnotics and sedatives for medical purposes. It has been estimated that the prevalence of use of the barbiturate sedatives, -58-

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phenobarbital and butabarbital, is about three percent. Adjusting for this, it would appear that about six percent of the population over 18 (about 8.5 million people) had used a prescription hypnotic during the preceding year. However, only about 45 percent of them, or almost four million, had used such a drug within the preceding month. Both surveys found that the proportion of people who had used a hypnotic increased with age. The 1971 national survey estimated that about 23 percent of those who had used a hypnotic within the past year had reached a "high" level of use - that is they reported using the drug every night or almost every night for two months or more at some time in their lives. About one-third had used hypnotics for more than two weeks in this manner. These data suggest that between six and nine million adults may be expected to use hypnotic medication at some time during a given year About one-third of these will use it regularly on consecutive nights for two weeks. -59- .

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REFERENCE S 1 2 3 4 5 6 7 8 9 10 Hammond, E.C., Some prel iminary findings on physical complaints from a prospective study of 1,064,004 men and women. Am. J. of Public Health 54:11-23,1964. McGhie, A. and Russel, S.M., The subjective assessment of normal sleep patterns. J. Ment. Sci. 108:642-654, 1962. - Balter, M.B. and Bauer, M.L., Patterns of prescribing and use of hypnotic drugs in the United States. In Sleep Disturbance and Hypnotic Drug Dependence, ed. by Clift, A.D., (Excerpta Medica: NY), 1975. Kales, A., Kales, J.D., and Bixler, E.O., Insomnia: an approach to management and treatment. Psychiat. Ann. 4~7~:28-44, 1974. Bixler, E.D., Kales, A., Soldatus, C.R. and Scharf, M.B., Use of hypnotic medication: physician and general public surveys. Sleep Research 7 (in press) Karacan, I., Thornby, J.I., Anch., M., Holzer, C.B., Warheit, G.J., Schwab, J.J., William, R.L., Prevalence of sleep disturbance in the general urban Florida county. Soc. Sci. Med. 10~5~:239-244, 1976. National Disease and Therapeutic Index (1977), IMS America Ltd., - Ambler, Pennsylvania. National Center for Health Statistics, DHEW, National Ambulatory Care survey, 1976. Johnson, J. and Clift, A.D., Dependence on hypnotic drugs in general practice, Brit. Med. Journal, 4:613, 1968. American Hospital Association, Hospital Statistics 1976 Edition, Chicago, 1976. —60—

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11 12 13 14 15 Shapiro, S., Slone, D., Lewis, G.P., and Jick, H., Clinical effects of hypnotics. II. An epidemiologic study. JAMA, 209: 2016-20, 1969. Morrison, D. and Mayfield, D.G., Sleep Insurance: A valid use of hypnotics? N.C. Med. J. 33: 862-865, 1972. Derived from data provided to D. Kripke, M.D. by the V.A. Marketing Center, Hines, Illinois, 1971. U.S. Department of Health, Education, and Welfare, National Institute of Drug Abuse, Sedative-Hypnotic Drugs: Risks and Benefits, edited by Cooper, J.R., Alcohol, Drug Abuse, and Mental Health Administration (August 1977). National Institute on Drug Abuse; National Survey on Drug Abuse: 1977, Volume l, Main Findings (DHEW Publication No. (ADM) 78-618) -61- .

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