Sleeping Pills, Insomnia, and Medical Practice Report of a Study (1979) / Chapter Skim
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Chapter 6: Conclusions
Chapter 6: Conclusions
Pages 137-154
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From page 137... ...
Diagnostic Appraisal A thorough medical and psychosocial appraisal of the insomniac patient should precede any decision to prescribe drugs for relief of the sleep complaint. Recent developments in sleep disorders research permit a more detailed diagnostic classification of insomnia complaints than was previously possible.
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From page 138... ...
Data are lacking with which to judge the efficacy and safety of long-term nightly use of hypnotics; currently, the consensus of sleep disorders specialists seems to be that hypnotic drugs should not be the primary form of treatment for most patients with persistent insomnia. The committee urges physicians to closely monitor patients receiving these medications, and generally refrain from providing automatic or "as needed" refills.
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From page 139... ...
-- Women of childbearing age who receive prescriptions for either benzodiazepine or barbiturate hypnotics should be told they may use them in future episodes of insomnia only if they are certain that they are not pregnant at that time, or if instructed to do so by a physician . -- With any hypnotic, patients should be advised of the potential for the development of habituation in the form of nightly reliance on sleeping pills.
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From page 140... ...
Nationally, there is a need for adequate toxicological analyses to provide more reliable data with which to assess the role played by psychotropic drugs in suicide and various kinds of accidental death or injury. Epidemiology Current national mortality and morbidity statistics are inadequate for determining the extent and source of drug problems in the United States.
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From page 141... ...
This represents a significant change from the state of affairs a decade ago, when barbiturate hypnotics and glutethimide were overwhelmingly predominant; this in part reflects the medical profession's response to some well-known advantages of the benzodiazepines -- especially their relative safety when taken alone in attempted suicidal overdose and the absence of interference with actions of certain other drugs, especially anticoagulants. From anecdotal and clinical reports, the committee noted that physicians have found patient satisfaction with benzodiazepines generally to be about equal to that obtained from barbiturate hypnotics; and physicians have preferred to continue prescribing benzodiazepines because of their reputation for safety.
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From page 142... ...
They pose hazards that have been insufficiently appreciated, while the narrow margin of overdose safety of barbiturate hypnotics appears to be well-known to the medical profession. As for efficacy, the committee concludes that both types of drugs are probably equally effective in short-term use.
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From page 143... ...
C Professional Education The findings of current and future research into sleep disorders and medication for their treatment must be translated for possible clinical use by practicing physicians.
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From page 144... ...
Programs on insomnia should become part of the continuing medical education that has become mandatory in many jurisdictions and in several specialty societies. The incentive to become proficient in this area would be increased if licensing and specialty board examinations would give sleep disorders a prominence commensurate with their occurrence in clinical practice and if research in this area were encouraged by appropriate federal support.
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From page 145... ...
Instead of stating that blood levels on the eighth morning after a week of consecutive nightly use are likely to be four to six times that found on the first morning, with concomitant potential for adverse daytime effects, the new prescribing information places the clinical implications of the drug's "pharmacokinetic profile" in a wholly favorable light.*
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From page 146... ...
Only three hypnotic drugs -- none of them a barbiturate -- are currently advertised to the medical profession in the United States. Examination of current advertisements raises doubts about whether they present balanced, clinically relevant information to aid the conscientious physician in prescribing.
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From page 147... ...
Their daytime functioning as well as nighttime sleep measurements need to be studied; (5) of the actual mechanisms whereby hypnotic drugs promote sleep.
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From page 148... ...
Prior to selection for study, the patients need to be carefully evaluated from a multidisciplinary point of view, with special attention to objective and subjective sleep characteristics, including appropriate tests to diagnose specific sleep disorders such as sleep apnea and nocturnal myoclonus; the patients also need to be evaluated from the point of view of daytime functioning, mood, and psychopathology.
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From page 149... ...
Above all these goals must be related to the actual problems. Many sleep laboratory studies have omitted significant descriptions of the subjective complaints of the individuals whose responses to hypnotic drugs were being measured.
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From page 150... ...
have supported studies of sleep physiology and sleep disturbance associated with such specific mental disorders as depression or schizophrenia, the amount of clinical investigation directed toward treatment methods for insomnia has been negligible. A few studies of the efficacy of L-tryptophan, a dietary supplement not marketed as a drug, have been supported by the National Institute on Drug Abuse.
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From page 151... ...
Some studies have been funded by the National Institutes of Health specifically on sleep apnea and nocturnal myoclonus, and the NIH has provided support for the multifaceted studies of the Boston Collaborative Drug Surveillance Program, including several clinical studies of hypnotic drugs in hospital patients. There has been a modest amount of intramural clinical study within the Veterans Administration hospital system.
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From page 152... ...
It could-coordinate the consensus development and professional and public education efforts in the field of sleep disorders, as well as identify promising research for grant funding or intramural programs of the Public Health Service. The committee recognizes that many of the problems associated with treatment of insomnia and the medical use of hypnotic drugs resemble those encountered in the clinical management of other health care problems -- which also require evaluation and professional education by those without a commercial stake in the results.
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From page 153... ...
and Kales, J.D., Sleep laboratory studies of flurazepam: A model for evaluating hypnotic drugs. Clinical Pharmacology and Therapeutics 19:576-583, 1976.
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