Evaluation of the safety and efficacy of quazepam for the treatment of insomnia in psychiatric outpatients.

BACKGROUND: This study was conducted to further evaluate the safety and efficacy of the benzodiazepine hypnotic quazepam within the context of a clinical practice setting of psychiatric outpatients who had insomnia. METHOD: A total of 2,813 adult, psychiatric outpatients were evaluated in an open-label study design. Each subject was instructed to take one 15-mg quazepam tablet each night at bedtime for 7 consecutive nights and was given a questionnaire to be completed at home upon arising each morning. RESULTS: Insomnia improved after 1 night of treatment with 15 mg of quazepam. Eighty-five percent of patients rated their quality of sleep as fair-to-excellent after 1 week of treatment. Similar efficacy outcomes also were observed on the second through sixth nights of treatment. Improvement occurred for patients who had an initial sleep latency complaint or unsatisfactory duration of sleep and for those who either had difficulty in staying asleep or complained of early morning awakening. The mean number of insomnia complaints was significantly (p < .001) reduced after the first and the seventh nights of treatment both in the population of all evaluable patients and in a subset of patients with more severe insomnia. CONCLUSION: This open-label study in 2,813 outpatients provided evidence that quazepam reduces the complaints of insomnia in a difficult-to-treat psychiatric population after 1 night and after 7 nights of treatment. Quazepam was well tolerated, even when coadministered with psychotherapeutic medications, some of which can cause insomnia.