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OCR for page R1
REPORT OF A STUDY
Sleeping Pills,
Insomnia, and
Meclical Practice
NATIONAL
ACADEMY of
SCI ENCES
Washington, D.C. 1979
OCR for page R2
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
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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
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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
-
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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.
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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
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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
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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
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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
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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
