COMPARISON OF THE EFFICACY AND TOLERABILITY OF ZOLPIDEM 20 MG AND TRIAZOLAM 0.5 MG IN ANXIOUS OR DEPRESSED INSOMNIAC PATIENTS

The effects of zolpidem 20 mg and triazolam 0.5 mg during 3 months' administration to psychiatric patients with sleep disorders were compared in a double-blind study in two parallel groups of patients. After completing a 3-day placebo run-in period, patients entered an active treatment phase, with clinical evaluations made from days 8 to 90, followed by a 1-month withdrawal period and a postdrug assessment on day 120. Ninety-five patients were included, 47 in the zolpidem group and 48 in the triazolam group. Sixty-two patients completed the trial. Efficacy of treatment was evaluated by overall clinical assessment, sleep onset latency, duration and quality of sleep, number of nocturnal awakenings, and the total nocturnal awake time. All sleep variables evaluated showed an improvement during the active treatment phase, irrespective of the treatment group; there was no statistically significant difference between zolpidem or triazolam in terms of efficacy. The anxiety state of the patients also improved in both treatment groups with no difference between the zolpidem- and triazolam-treated patients. Overall clinical and cardiovascular safety were good in both treatment groups, and there were no significant changes in any of the laboratory parameters. Thus zolpidem has been shown to be as safe and effective as triazolam in the treatment of psychiatric patients with sleep disorders.