Zolpidem in the treatment of short-term insomnia: a randomized, double-blind, placebo-controlled clinical trial

Zolpidem was evaluated in this double-blind, randomized, placebo-controlled study for efficacy and safety in patients with short-term insomnia related to problems with work, marriage, family, or financial matters. One hundred and thirty-eight patients ranging in age from 20 to 55 years were evaluated for safety. Of these, 136 patients were included in the analysis of efficacy. Patients received zolpidem 10 mg or placebo nightly for 7-10 nights. Patients completed a morning questionnaire daily, reported their global impressions of therapy, and completed a Profile of Mood States (POMS) at the start and end of the study. Nine patients (three zolpidem and six placebo) discontinued before completing the study; three (one zolpidem and two placebo) due to adverse events. Compared to placebo, zolpidem significantly reduced subjective latency to sleep on all nights of treatment and patients rated that falling asleep was easier with zolpidem than with placebo (p < 0.01) throughout the study. Compared to placebo, the zolpidem-treated patients reported longer total sleep time, fewer awakenings after sleep onset, shorter time spent awake after sleep onset and better quality of sleep. All of these differences were significant during at least part of the study. No morning sleepiness or impairment in the ability to concentrate were recorded among patients taking zolpidem. Each item on the patient's global impression of zolpidem therapy was rated significantly better than that of placebo. No changes in mood (including anxiety) were detected using the POMS scale. Side effects occurred with a similar frequency in the zolpidem and placebo groups. Zolpidem was found to be more effective than placebo and was well tolerated in the management of stress-induced short-term insomnia.