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Chronic Hypnotic-Drug Use: Title and subTitle BreakIneffectiveness, Drug-Withdrawal Insomnia, and Dependence FREE

Anthony Kales, MD; Edward O. Bixler, PhD; Tjiauw-Ling Tan, MD; Martin B. Scharf; Joyce D. Kales, MD
[+] Author Affiliations

Reprint requests to Sleep Research and Treatment Facility, Milton S. Hershey Medical Center, 500 University Dr, Hershey, PA 17033 (Dr. Kales).


JAMA. 1974;227(5):513-517. doi:10.1001/jama.1974.03230180011004
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Ten patients, each of whom had been using hypnotic drugs for periods ranging from months to years, were monitored in the sleep laboratory while continuing to receive medication. Comparison with insomniac controls who were not receiving medication demonstrated a significant decrease of rapid eye movement (REM) sleep in the chronic drug users. A striking finding was the fact that all of these patients had as great or greater difficulty in falling asleep or staying asleep, or both, than the insomniac controls who were not using medication. Abrupt withdrawal of ineffective drugs is not recommended due to psychological and physiological changes that contribute to drug-withdrawal insomnia and hypnotic-drug dependence. The ineffectiveness of hypnotic drugs demonstrated in this study and in our earlier sleep laboratory drug evaluation studies indicates the need for changes in the guidelines used for evaluating and advertising hypnotic drugs.

REFERENCES

Kales A, Kales JD:  Evaluation, diagnosis and treatment of clinical conditions related to sleep . JAMA 213:2229-2235, 1970;.
Kales A, et al:  Hypnotic drugs and their effectiveness: All night EEG studies of insomniac subjects . Arch Gen Psychiatry 23:226-232, 1970;.
Kales A, Cary G:  Insomnia, evaluation, and treatment , in Robins E (ed): Psychiatry (suppl to Medical World News) , pp 55-56, 1971;.
Kales A, et al:  Psychological evaluation and treatment studies of insomniac subjects . Psychophysiology 9:137, 1972;.
Rechtschaffen A, Kales A (eds): A Manual of Standardized Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects, publication 204. Public Health Service Publications, US Government Printing Office, 1968.
Kales A, et al:  All night sleep studies in hypothyroid patients, before and after treatment . J Clin Endocrinol Metab 27:1593-1599, 1967;.
Kales A, et al:  Hypnotics and altered sleep-dream patterns: II. All night EEG studies of chloral hydrate, flurazepam, and methaqualone . Arch Gen Psychiatry 23:219-225, 1970;.
Kales A, et al:  Hypnotics and altered sleep-dream patterns: I. All night EEG studies of glutethimide, methyprylon, and pentobarbital . Arch Gen Psychiatry 23:211-218, 1970;.
Wyatt R, et al:  Longitudinal studies of the effects of monoamine oxidase inhibitors on sleep in man . Psychopharmacologia 15:236-244, 1969;.
Oswald I, Priest RG:  Five weeks to escape the sleeping pill habit . Br Med J 2:1093-1099, 1965;.
Oswald I, Thacore VR:  Amphetamine and phenmetrazine addiction: Physiological abnormalities in the abstinence syndrome . Br Med J 2:427, 1963;.
Kales A, et al:  Psychophysiological and biochemical changes following use and withdrawal of hypnotics , in Kales A (ed): Sleep: Physiology and Pathology . Philadelphia, JP Lippincott Co, pp 331-343, 1969;.
Kales A, et al:  Sleep laboratory effectiveness studies of secobarbital and methaqualone . Read before the 74th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, New Orleans, 1973 .
Food and Drug Administration Guidelines for the Evaluation of New Hypnotic Drugs . Prepared by a joint committee of the Pharmaceutical Manufacturers Association and the Food and Drug Administration, 1971;.

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Kales A, Kales JD:  Evaluation, diagnosis and treatment of clinical conditions related to sleep . JAMA 213:2229-2235, 1970;.
Kales A, et al:  Hypnotic drugs and their effectiveness: All night EEG studies of insomniac subjects . Arch Gen Psychiatry 23:226-232, 1970;.
Kales A, Cary G:  Insomnia, evaluation, and treatment , in Robins E (ed): Psychiatry (suppl to Medical World News) , pp 55-56, 1971;.
Kales A, et al:  Psychological evaluation and treatment studies of insomniac subjects . Psychophysiology 9:137, 1972;.
Rechtschaffen A, Kales A (eds): A Manual of Standardized Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects, publication 204. Public Health Service Publications, US Government Printing Office, 1968.
Kales A, et al:  All night sleep studies in hypothyroid patients, before and after treatment . J Clin Endocrinol Metab 27:1593-1599, 1967;.
Kales A, et al:  Hypnotics and altered sleep-dream patterns: II. All night EEG studies of chloral hydrate, flurazepam, and methaqualone . Arch Gen Psychiatry 23:219-225, 1970;.
Kales A, et al:  Hypnotics and altered sleep-dream patterns: I. All night EEG studies of glutethimide, methyprylon, and pentobarbital . Arch Gen Psychiatry 23:211-218, 1970;.
Wyatt R, et al:  Longitudinal studies of the effects of monoamine oxidase inhibitors on sleep in man . Psychopharmacologia 15:236-244, 1969;.
Oswald I, Priest RG:  Five weeks to escape the sleeping pill habit . Br Med J 2:1093-1099, 1965;.
Oswald I, Thacore VR:  Amphetamine and phenmetrazine addiction: Physiological abnormalities in the abstinence syndrome . Br Med J 2:427, 1963;.
Kales A, et al:  Psychophysiological and biochemical changes following use and withdrawal of hypnotics , in Kales A (ed): Sleep: Physiology and Pathology . Philadelphia, JP Lippincott Co, pp 331-343, 1969;.
Kales A, et al:  Sleep laboratory effectiveness studies of secobarbital and methaqualone . Read before the 74th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, New Orleans, 1973 .
Food and Drug Administration Guidelines for the Evaluation of New Hypnotic Drugs . Prepared by a joint committee of the Pharmaceutical Manufacturers Association and the Food and Drug Administration, 1971;.
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