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 an d efficacy of the benzodiazepine hypnotic quazepam within the context of a clinical practice setting of psychiatric outpatients who had inso mnia. Method: A total of 2813 adult, psychiatric outpatients were eval uated in an open-label study design. Each subject was instructed to ta ke one 15-mg quazepam tablet each night at bedtime for 7 consecutive n ights and was given a questionnaire to be completed at home upon arisi ng each morning. Results: Insomnia improved after 1 night of treatment with 15 mg of quazepam. Eighty-five percent of patients rated their q uality of sleep as fair-to-excellent after 1 week of treatment. Simila r efficacy outcomes also were observed on the second through sixth nig hts of treatment. Improvement occurred for patients who had an initial sleep latency complaint or unsatisfactory duration of sleep and for t hose who either had difficulty in staying asleep or complained of earl y morning awakening. The mean number of insomnia complaints was signif icantly (p < .001) reduced after the first and the seventh nights of t reatment both in the population of all evaluable patients and in a sub set of patients with more severe insomnia. Conclusion: This open-label study in 2813 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 tole rated, even when coadministered with psychotherapeutic medications, so me of which can cause insomnia.