Quazepam in the short-term treatment of insomnia in outpatients

The safety and hypnotic efficacy of quazepam 30 mg vs placebo in 57 insomniac outpatients were assessed in a randomized, controlled comparison. Patients received placebo during a 3-night, single-blind baseline period, and then quazepam 30 mg or placebo during a 5-night, double-blind treatment period. Quazepam-treated patients reported significantly better sleep quantity and quality on the first treatment night and for the overall treatment period than did placebo patients. No clinically significant change was seen in pre- and posttreatment physical examinations, electrocardiograms, or routine laboratory tests. Of the 57 subjects, 20 (16 quazepam, 4 placebo) reported adverse experiences. All 20 reported daytime somnolence (drowsiness, lethargy, or sleepiness), and one quazepam-treated patient also had hypokinesia. Overall, quazepam 30 mg was a safe and effective hypnotic, with significant hypnotic activity on the first night of administration.