Date: Nov. 12, 1997
Contacts: Dan Quinn, Media Relations Officer
Sean McLaughlin, Media Relations Assistant
(202) 334-2138; Internet <>

Halcion Called Safe and Effective When Used as Recommended;
Use Beyond Labeling Recommendations Warrants FDA Action

WASHINGTON -- The sleeping pill Halcion is safe and effective when used as recommended on the label approved by the Food and Drug Administration, according to a new report from a committee of the Institute of Medicine (IOM). However, more research is needed to determine the long-term effects of the drug, which often is prescribed for longer periods and at higher doses than recommended on the label. The committee urged the Food and Drug Administration (FDA) to establish an independent task force to address the prescribing patterns and use of all hypnotic drugs, including Halcion, which has been prescribed at levels inconsistent with the label to tens of thousands of people in the United States alone.

"The data do not support the contention that Halcion presents a greater health risk than other drugs of its type, as long as it is used according to the FDA-approved instructions on the label," said committee chair William Bunney, professor, University of California, Irvine. "However, Halcion has not been thoroughly tested for the way it often is being used, which is at much higher doses and longer durations than recommended." In addition to looking more carefully at Halcion's long-term effects, the FDA should aggressively confront the serious health problems that may result from the use of prescription drugs beyond labeling recommendations, the committee said.

Halcion quickly became popular after it was approved by the FDA in 1982, largely because it was considered safer and was associated with less daytime residual grogginess than the alternatives. By the early 1990s, however, concerns about Halcion's possible link to anxiety, depression, amnesia, and paranoid delusions convinced several countries -- including the United Kingdom, Brazil, Argentina, Norway, and Denmark -- to ban its sale. An FDA task force concluded in 1996 that the drug was safe and effective when used as labeled; however, the task force recommended that an independent organization examine the data on Halcion as well, which led to the IOM study. As many as 10 percent of adults in the United States are chronic insomniacs. Sleep problems and efforts to ameliorate them cost an estimated $100 billion each year in the United States. Hypnotic drugs also are used to help people cope with stress, jet lag, or other interruptions in their normal sleep patterns.

In evaluating the safety and efficacy of Halcion, the committee examined much of the data gathered from clinical trials as well as the published literature. It independently assessed the quality of the clinical trials performed prior to the manufacturer's submission of Halcion for FDA approval, and performed its own analysis of the data generated from the trials. The report notes a discrepancy between the incidence of adverse events in initial clinical trials and the far greater incidence of adverse events reported after the drug was put on the market.

This discrepancy may have occurred because once Halcion was marketed to the general public and became popular, adverse events were more likely to be detected. Clinical trials, which operate under tightly controlled circumstances, limit the number and types of people who take the drug. Additionally, external influences such as media attention and litigation may have contributed to the rise in complaints, the report says.

Long-Term Follow-up Needed

Clinical trials that spanned about six weeks showed Halcion to be effective at inducing sleep without producing tolerance to the drug, the committee said. But because tens of thousands of prescriptions are being written for much longer periods, the FDA should revise and update its clinical evaluation guidelines to examine whether a drug is safe and effective over extended periods of time, the report says.

After any drug is approved, insufficient amounts of data are collected concerning actual use, and inadequate effort is directed toward trying to link information on usage to adverse events, the report says. The FDA should take steps to increase surveillance of health problems arising from all drugs after they are approved and put on the market. Specifically, the FDA should:

>create an independent task force to review and develop mechanisms for improving prescribing practices and patient use of hypnotic drugs. Such an effort could lead to educational materials to alert physicians about the possible effects from prescribing drugs differently than recommended.

>improve its ability to assess the findings of clinical trials and post-marketing surveillance, and to resolve any discrepancies in the information coming from patients, health care providers, and controlled clinical trials.

>conduct research aimed at identifying the most valid and reliable ways to measure the effectiveness of hypnotic drugs, including studies designed to integrate both descriptive and measurable responses to the drugs.

A committee roster follows. The study was funded by the Food and Drug Administration. The Institute of Medicine is a private, non-profit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences.

Copies of Halcion: An Independent Assessment of Safety and Efficacy Data  are available at or by calling 202-334-3313  or 1-800-624-6242. Reporters may obtain a pre-publication copy from the Office of News and Public Information at the letterhead address (contacts listed above).


Division of Health Sciences Policy
Division of Neuroscience and Behavioral Health

Committee on Halcion: An Assessment of Data
Adequacy and Confidence

William Bunney* (chair)
Distinguished Professor and Della Martin Chair of Psychiatry
Department of Psychiatry and Human Behavior
University of California

Daniel Azarnoff*
D.L. Azarnoff Associates
Burlingame, Calif.

Byron Wm. Brown Jr.*
Professor and Head
Division of Biostatistics
Department of Health Research and Policy
Stanford University
Stanford, Calif.

Robert Cancro
Professor and Chairman
Department of Psychiatry
New York University Medical Center
New York City

Robert Gibbons
Professor of Biostatistics
Department of Psychiatry
University of Illinois

John Christian Gillin
Professor of Psychiatry
University of California
San Diego, and
Veterans Affairs Medical Center

Sandral Hullett*
Executive Director
West Alabama Health Services Inc.

Keith Killam
Professor and Chair Emeritus
Department of Pharmacology and Toxicology
University of California

John Krystal
Associate Professor of Psychiatry, and
Director, Division of Cognitive and Clinical Neuroscience
Yale University
New Haven, Conn.

David Kupfer*
Professor and Chairman of Psychiatry
University of Pittsburgh School of Medicine, and
Director of Research
Western Psychiatric Institute and Clinic

Paul Stolley*
Professor and Chairman
Department of Epidemiology and Preventive Medicine
School of Medicine
University of Maryland


Andrew Pope
Study Director

Valerie Petit Setlow
Division of Health Sciences Policy

Connie Pechura
Division of Neuroscience and Behavioral Health

(*) Member, Institute of Medicine