Assessment of the safety and efficacy data for the hypnotic Halcion (R): Results of an analysis by an Institute of Medicine Committee

Recent estimates indicate a 10% prevalence of chronic insomnia in the adult population of the United States, with an associated annual cost of more th an $90 billion. Since its approval in 1982 for use in the treatment of inso mnia, an estimated 11 billion prescriptions for Halcion(R) (triazolam) have been filled worldwide. Concerns about the safety of Halcion began to emerg e when a Dutch psychiatrist reported a possible link between the drug and a syndrome that included depression, amnesia, hallucinations, and anxiety. S ince that time, the United Kingdom, Brazil, Argentina, Norway, and Denmark removed Halcion from the market, and the manufacturer, Upjohn, withdrew Hal cion from the market in The Netherlands. Other countries, including the Uni ted States and Canada, modified the labeling to reduce the recommended dose and duration of treatment and to heighten awareness regarding possible sid e effects affecting behavior and cognition. The labeling changes raised que stions regarding the hypnotic effectiveness of these lower doses of Halcion . Based on a 1996 U.S. Food and Drug Administration (FDA) task force report , the Institute of Medicine (IOM) of the National Academy of Sciences asses sed the adequacy, quality, and overall confidence in the data on the effect iveness and safety of Halcion at different doses and durations, including t hose specified in the current product labeling. This article provides a sum mary of the IOM report titled "Halcion: An Independent Assessment of Safety and Efficacy Data" and a more detailed overview of the statistical analysi s that led to the committee's conclusions.