Evaluation of zolpidem, triazolam, and placebo as hypnotic drugs the night before surgery.

Author(s): Morgan PJ, Chapados R, Chung FF, Gauthier M, Knox JW, Le Lorier J

Affiliation(s): Department of Anaesthesia, University of Toronto, Ontario, Canada.

Publication date & source: 1997-03, J Clin Anesth., 9(2):97-102.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

STUDY OBJECTIVE: To compare the hypnotic effects of a bedtime dose of zolpidem, triazolam, and placebo. DESIGN: "Double-blind, randomized, placebo- and active-controlled, parallel-group" trial. SETTING: Six Canadian hospitals. PATIENTS: 357 patients (aged 19 to 71 years) hospitalized the night before a surgical procedure. INTERVENTIONS: At bedtime, each patient received either zolpidem 10 mg, triazolam 0.25 mg, or placebo, and was allowed to sleep for a maximum of 8 hours. MEASUREMENTS: Outcome measures were subjective in nature and included a morning questionnaire, visual analog scales, and observation forms by study personnel. All continuous variables were analyzed by analysis of variance. All categorical data were compared using the Cochran-Mantel-Haenszel (CMH) test, and the percentage of patients asleep was compared using a CMH chi-square analysis. When significant overall treatment effects were observed, pairwise comparisons were undertaken. Compared with the placebo group, the following parameters were significantly (p < 0.001) different in the zolpidem and triazolam groups: sleep latency was shorter, total sleep time was longer, patients fell asleep more easily, and the number of patients awake 2 hours after drug administration was lower. There were no differences between any groups in next-morning somnolence or ability to concentrate. Both drugs were well tolerated, with adverse event incidence rates nearly identical to placebo. CONCLUSIONS: In patients suffering from transient insomnia, a single dose of zolpidem 10 mg was as effective as triazolam 0.25 mg, and both were more effective than placebo and were well tolerated.