Evaluation of the Short-Term Treatment of Insomnia in Out-Patients with 15 Milligrams of Quazepam

The short-term safety and hypnotic efficacy of 15 mg of quazepam was compared with that of placebo in a double-blind study in sixty out-patients with insomnia. All patients received placebo for 3 consecutive nights to establish a baseline; for the next 5 nights thirty patients received quazepam and thirty received placebo. The results indicated that quazepam was significantly more effective than placebo in terms of quantity and quality of sleep and that quazepam was effective on the first night. Despite having a marked hypnotic effect, quazepam was not different from placebo in terms of hang-over effects (i.e., ease in awakening and alertness) the following morning. Treatment-related adverse experiences were reported by ten patients who received quazepam and by five who received only placebo. The most frequently reported adverse experience was daytime somnolence. This study demonstrates that quazepam, in a 15 mg dose, is an effective, rapidly acting, oral hypnotic agent with a low incidence of adverse effects.