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Report of the Institute of Medicine Committee on the Efficacy and Safety of Halcion
William E. Bunney, Jr, MD;
Daniel L. Azarnoff, MD;
Byron W. Brown, Jr, PhD;
Robert Cancro, MD;
Robert D. Gibbons, PhD;
John C. Gillin, MD;
Sandral Hullett, MD, PhD;
Keith F. Killam, PhD;
David J. Kupfer, MD;
John H. Krystal, MD;
Paul D. Stolley, MD, MPH;
Geoffrey S. French, MA;
Andrew M. Pope, PhD
Arch Gen Psychiatry. 1999;56:349-352.
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INTRODUCTION
Recent estimates indicate that there is a 10% prevalence of chronic insomnia in the adult population of the United States, with an associated annual cost of $90 to $107 billion.1 Since its approval in 1982 for use in the treatment of insomnia, an estimated 11 billion prescriptions for Halcion (triazolam) have been filled worldwide.2 Halcion refers to the actual product that is manufactured and marketed by the Upjohn Co (hereinafter, Upjohn), Kalamazoo, Mich. Triazolam is the generic name of the pure active ingredient in Halcion. The committee uses the term Halcion in the text when it . . . [Full Text of this Article]
ASSESSMENT OF EFFICACY DATA
DATA ADEQUACY
Recommendation 1.
CLINICAL TRIAL DESIGN
Recommendation 2. Recommendation 3.
TOLERANCE
Recommendation 4.
ASSESSMENT OF SAFETY DATA
CLINICAL TRIALS AND SURVEILLANCE
Recommendation 5.
BROADER IMPLICATIONS
Recommendation 6. Recommendation 7.
Drs Bunney (chair), Azarnoff, Brown, Cancro, Gibbons, Gillin, Hullett, Killam, Kupfer, Krystal, and Stolley are members of the Institute of Medicine Committee on the Efficacy and Safety of Halcion; Mr French and Dr Pope are staff members of the Institute of Medicine, Washington, DC. Dr Killam is deceased.
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