Evaluation of zolpidem, triazolam, and placebo as hypnotic drugs the night before surgery.
OBJECTIVE
To compare the hypnotic effects of a bedtime dose of zolpidem, triazolam, and placebo.


METHODS
"Double-blind, randomized, placebo- and active-controlled, parallel-group" trial.


METHODS
Six Canadian hospitals.


METHODS
357 patients (aged 19 to 71 years) hospitalized the night before a surgical procedure.


METHODS
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.


METHODS
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.
Morgan
P J
PJ
Department of Anaesthesia, University of Toronto, Ontario, Canada.
Chapados
R
R
Chung
F F
FF
Gauthier
M
M
Knox
J W
JW
Le Lorier
J
J
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011229:Preanesthetic Medication; D011725:Pyridines / Q000009:adverse effects; D012890:Sleep / Q000187:drug effects; D014229:Triazolam / Q000009:adverse effects; D000077334:Zolpidem
D006993:Hypnotics and Sedatives; D011725:Pyridines; D014229:Triazolam; D000077334:Zolpidem