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REPORT OF A STUDY Sleeping Pills, Insomnia, and Meclical Practice NATIONAL ACADEMY of SCI ENCES Washington, D.C. 1979
NOTICE that is of the The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the Councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee '~ponsibJe for the report were chosen for their special competence and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This study was supported by the Executive Office of the President and the Department of Health, Education, and Welfare, Alcohol, Drug Abuse and Mental Health Administration, National Institute on Drug Abuse. Executive Office of the President, Contract No. DA-7AC-001. Publication IOM-79-04 The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of medi- cal and other professions for the examination of policy matters per- taining to the health of the public. In this, the Institute acts under both the Academy's 1863 Congressional charter responsibility to be an advisor to the Federal Government, and its own initiative in identifying issues of medical care, research, and education. International Standard Book Number 0-309-02881-7 Library of Congress Catalog Card Number 79-87705 Available from Office of Publications National Academy of Sciences 2101 Constitution Avenue, N.W. Washington, D.C. 20418 Printed in the United States of America
TABLE OF CONTENTS Preface Steering Committee and Study Staff Acknowledgments INTRODUCTION AND SUMMARY Chapter 1. AN OVERVIEW OF SLEEP AND MEDICATION A. The Anatomy of Sleep B. Prescription Drugs Marketed as Hypnotics C. Prescription Drugs Not Marketed as Hypnotics D. Self-medication for Sleep Page y V1 1 17 Chapter 2. EPIDEMIOLOGY OF SLEEP COMPLAINTS AND PRESCRIBING 47 PRACTICES A. Prevalence of Sleep Complaints B. Trends in Prescribing Medication for Sleep C. The Physician's Diagnostic and Therapeutic Responses D. Hospital Use of Hypnotic Drugs E. The Population's Use of Hypnotics Chapter 3. PUBLIC HEALTH PROBLEMS ASSOCIATED WITH THE USE OF HYPNOTIC DRUGS A. Suicide and Accidental Overdose B. Traffic Safety C. Non-medical Use of Drugs Chapter 4. INSOMNIA: RESEARCH FINDINGS, DIAGNOSTIC APPROACHES, AND THERAPEUTIC OPTIONS A. The Meaning of Insomnia B. Types of Insomnia C. The "Sleep Disorder History" D. Hypnotic Drug Therapy: An Overview E. Non-pharmacological Therapies for Insomnia · · ~ 63 81
Page Chapter 5. SLEEP DISTURBANCE IN THE ELDERLY A. Prevalence of Sleep Disturbance in the Elderly B. Hypnotic Drug Use by the Elderly C. Pharmacologic Treatment of Insomnia in Elderly Patients D. Non-pharmacologic Treatment of Sleep Disturbance Chapter 6. CONCLUSIONS A. Clinical Practice, Patient Information, and Public Health B. Benzodiazepines vs. Barbiturates as Hypnotic Drugs C. Professional Education D. Advertising and Labeling E. Research Needs F. Initiation and Coordination of Federal Efforts APPENDIX: ASSESSING THE HAZARDS AND BENEFITS OF HYPNOTIC DRUGS Approaches to the Study of the Effects of Hypnotic Drugs B. Daytime Residual Effects of Hypnotic Drugs C. Special Vulnerabilities to Hazards of Hypnotics: Respiratory Difficulties, Kidney Disease, and Pregnancy Issues in the Long-Term Use of Hypnotic Drugs An Overview of Available Studies of Hypnotic Drug Efficacy 1V 119 137 155 -
PREFACE In August 1977, President Carter called for studies to review the safety and usefulness of hypnotic drugs, especially the barbiturates, and to examine physician prescribing practices with respect to these drugs. The Institute of Medicine, recognizing the importance and serious- ness of the issues associated with these drugs, agreed to undertake a study of use of hypnotic drugs in medical practice for the White House and the National Institute on Drug Abuse. The report that follows contains the results of that study.* As is customary for Institute of Medicine studies, this report has been prepared by a steering committee consisting of both Institute members and non-members, specialists in such areas as internal medicine, psychiatry, pharmacology, consumer affairs, sleep research and food and drug law. As chairman of the committee, I would like to express my gratitude to my fellow members, who have been generous of their time and stimulating in their guidance to the staff. It has been my privilege, also, to work with a dedicated and competent staff, under the direction of Dr. Fredric Solomon and Catherine C. White. Dr. David Hamburg, President of the Institute of Medicine, has provided much personal and timely advice and I would like to take this opportunity to thank him. The report reviews both clinical issues and public health problems associated with the prescribing of hypnotic drugs. Recognizing that issues like these are not unique to the clinical management of insomnia, we trust this report will further the future development of organized examinations of health care and therapeutics. William G. Anlyan, M.D. Chairman January, 1979 *A technical supplement to this report will be available later in 1979. It will contain a tabulation of sleep laboratory studies of the observed sleep of insomniacs; a comprehensive tabulation of studies of hypnotic drug efficacy; and a summary of several states' current approaches to monitoring physicians' prescribing practices.
INSTITUTE OF MEDICINE STEERING COMMITTEE Chairman William G. Anlyan, M.D. Members Mitchell B. Baiter, Ph.D. John P. Bunker, M.D. William C. Dement, M.D., Ph.D. Edwin C. Evans, M.D. Daniel X. Freedman, M.D., D.Sc. Christian Gillin, M.D. Frederick B. Glaser, M.D. Peter Goldman, M.D. Vice President for Health Affairs Duke University Medical Center Psychopharmacology Research Branch National Institute of Mental Health Professor of Anesthesia and of Family Community and Preventive Medicine Stanford University School of Medicine Professor of Psychiatry and Director Sleep Disorders Clinic and Research Center Stanford University Internist in Private Practice Atlanta, Georgia Professor and Chairman, Department of Psychiatry University of Chicago Acting Chief, Unit on Sleep Studies Intramural Program National Institute of Mental Health Professor of Psychiatry University of Toronto and Head of Psychiatry, Addiction Research Foundation Professor of Clinical Pharmacology Harvard Medical School vi
Hershel Jack, M e D. Eleanor C. Lambertsen, Ed.D., D.Sc. Jonathan Leff Richard Merrill, LL e B. Associate Professor of Medicine Boston University School of Medicine Boston Collaborative Drug Surveillance Program Dean, Cornell University - New York Hospital School of Nursing Consumers Union Mount Vernon, New York Professor of Law University of Virginia , . V11
INSTITUTE OF MEDICINE David A. Hamburg, M-D. President STAFF Fredric Solomon, M.D. Catherine C. White Guy Collier, J.D., M.P.H Kathryn G. King Delores Parron, Ph.D. CONSULTANTS . Wallace B. Mendelson, M.D. Markku Linnoila, M.D., PheD" Morris Rosenberg, Ph.D- Study Director and Director of the Division of Mental Health and Behavioral Medicine Associate Study Director Research Psychiatrist Unit on Sleep Studies National Institute of Mental Health Head, Clinical Pharmacology Laboratory Department of Psychiatry Duke University Medical Center Professor of Sociology University of Maryland viii
ACKNOWLEDGEMENTS Through their active assistance and collaboration, numerous individuals outside the Institute of Medicine greatly enriched this study. They provided helpful suggestions, timely observations and unpublished data bearing on the complex scientific, clinical and societal issues which were being explored by the committee and staff. We wish to especially express our gratitude for contributions made by: 0 Drs. Huda Akil, Mary Carskadon, Laughton Miles, Stanley Watson and Vincent Zarcone and Ms. Lynn Hassler, Stanford University Medical Center o Drs. B.M. Barraclough and A.D. Clift, Medical Research Council, Great Britain 0 Mr. Kenneth Durrin, U.S. Department of Justice, Drug Enforcement Administration o Drs. Bryan Finkle and Kevin McCloskey, University of Utah o Dr. John Fultz and Mr. Lawrence Slotnick, Illinois Department of Registration and Education o Mr. David Joranson, Wisconsin Controlled Substances Board o Drs. Anthony Kales and Martin Scharf, Milton Hershey Medical School of Pennsylvania State University o Dr. Ismet Karacan, Baylor University o Dr. Edward Khantzian, Cambridge Hospital o Mr. Thomas Kirkpatrick, Illinois Dangerous Drugs Commission o Dr. Daniel Kripke, San Diego Veterans Administration Hospital o Dr. Peretz Lavie, Haifa University, Israel o Drs. George Nakamura and Thomas Noguchi, Los Angeles County Depart- ment of Chief Medical Examiner-Coroner Dr. Edward Senay, Pritzker School of Medicine of the University of Chicago 0 Dr. Joseph Skom, Chicago Medical Society o Dr. Solomon Synder, John Hopkins Hospital and School of Medicine o Dr. Richard Wyatt, National Institute of Mental Health ix
In survey response s and in direc t discus s ion during the course of this study, more than fifty actively practicing physicians - including thirty-five members of the Institute of Medicine -- described their attitudes and approaches toward patients seemingly in need of sleeping med ication. These physicians were extraord inarily g enerous with their time and thoughtful in sharing their perspectives on the diverse problems under consideration. We also wish to acknowledge the support and assistance provided personally by the representatives of the contracting agencies -- Mr. Robert Angarola of the White House Drug Policy Office and Drs. James Cooper and James Ferguson of the National Institute on Drug Abuse. Finally, it should be noted that former Institute of Medicine staff members Michael Pollard, J. D ., M. P. H. and Melvena Sherard helped launch this study; that Juliana Goldberg, M.A. edited the manuscript; and that from its inception to its completion, Ms . Naomi Hudson skill- fully and patiently served as the proj ect' s secretary , . Fredric Solomon, M. D. Study Direc tor x