significant in terms of the health and well-being of the patient—the need for objective, critical assessments, better methods for detecting behavioral or psychological adverse events, and integrated evaluations of the entire body of information is critical.
Recommendation 6: Improve Postmarketing Data Collection and Analysis. The committee recommends that additional effort be dedicated to the postmarketing surveillance and monitoring of hypnotic agents and other drug products, and that this include objective and critical evaluations of integrated data sets of adverse events, actual patient use, and clinical trials. This effort should include special emphasis on developing improved methods for (1) collecting and integrating evaluation of patient use data and clinically significant adverse events, including behavioral or psychological events, and (2) responding effectively when signals appear in the spontaneous reports that correlate with data indicating patient use at higher doses and for longer durations than those that are recommended.
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. This task force should pay special attention to issues raised by the actual use of these agents and to the issues of appropriate differential diagnosis when addressing the problem of insomnia in patients. It would be useful to provide physicians with efficacy and adverse effects dose-response curves for durations comparable to those being used in practice, even if they are greater than those recommended in the labeling.
In addition, the committee recommends that professional societies of primary care and other health care providers increase their members' attention to the need for caution in prescribing hypnotic drugs at higher doses and for longer durations than those that are recommended. Efforts in this area should include increased attention to this issue in medical education and in residency programs, including the addition of questions about the use of hypnotic drugs on medical specialty examinations.
FDA should identify ways to disseminate information on the diagnosis and management of insomnia more effectively to medical students and in training programs for primary care physicians.