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Executive Summary
Pages 1-9

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From page 1...
... Since that time and for various reasons, the United Kingdom, Brazil, Argentina, Norway, and Denmark have removed Halcion from the market; Upjohn withdrew Halcion from the market in The Netherlands. Other countries, including the United States and Canada, modified the labeling to reduce the recommended dose and duration of treatment and to heighten awareness regarding possible side effects affecting behavior and cognition.
From page 2...
... To that end FDA requested that the institute of Medicine (IOM) assess the following: · the adequacy of the study designs and quantitative endpoints used in the major clinical trials of Halcion; · the quality and quantity of postmarketing data with respect to adverse drug reactions; · the overall confidence in the data on the effectiveness, adverse events, and side effects of Halcion at different doses and for different durations, including those specified in the current product labeling; and · the need for additional studies to clarify and characterize the risk and efficacy profiles of Halcion.
From page 3...
... Conclusions and Recommendations The following conclusions and recommendations are based on the committee's review and analysis of various types of data, including randomized, controlled (dose and duration) clinical trials, spontaneous reports of adverse events, and survey data.3 The postmarketing trials met current standards for a well-controlled clinical trial; the premarketing trials were adequate for the time and were sufficient to provide data of adequate quality to judge the effects of the drug.
From page 4...
... Definitive short-, interme~liate-, and long-term polysomnographic studies are needed in a geriatric population to determine the sleep architecture of elderly insomniacs using the 0.125-mg dose. Clinical Trial Design The study designs and quantitative endpoints (i.e., steep latency, duration, awakenings, and global assessment)
From page 5...
... produces adverse effects that are qualitatively similar to but quantitatively more frequent or severe than the adverse effects associated with drugs in the benzodiazepine class of drugs or drugs with benzodiazepine-like activity. Conclusions and Recommendations The data from premarketing clinical trials, postmarketing studies, and the published literature do not support clearly the existence of a unique profile or syndrome of adverse events associated with HaTcion relative to those associated with other drugs of its type.
From page 6...
... Many factors contribute to this apparent conflict, including the nature and design of clinical trials and external events that can affect the reporting of adverse events. it is important to note that the statistical power to detect rare events is necessarily limited in controlled clinical trials because such trials include a small number of subjects compared with the number of patients using the drug in the postmarketing period, and subjects admitted to the trials must conform to carefully defined inclusion and exclusion criteria, narrowing the likely range of adverse events; rare events are unlikely to be detected in sample populations of a few hundred subjects.
From page 7...
... The committee recommends that additional effort be dedicated to the postmarketing surveillance and monitoring of hypnotic agents and other drug products and that this effort include objective and critical evaluations of integrated sets of (lata on adverse events, on actual patient use, and from clinical trials. Special emphasis should be placed on developing improved methods for (~)
From page 8...
... Recommendation 7: Educate Health Care Providers. The committee recommends that FDA establish an independent task force with the charge of reviewing and developing mechanisms for improving prescribing practices and patient use of hypnotic medications.
From page 9...
... The overall confidence in the data on the effectiveness of, adverse events from, and side effects of Halcion at different doses and for different durations, including those specified in the current product labeling. The need for additional studies to clarify and characterize the risk and efficacy profiles of Halcion.


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