Estazolam, a triazolobenzodiazepine with an intermediate elimination half-life, has been shown previously to be an effective and safe
hypnotic in insomniacs without concomitant
psychiatric illness. Our study of the efficacy of
estazolam in patients with
insomnia associated with generalized
anxiety disorder began when 108 patients meeting criteria for generalized
anxiety disorder (mean total score of Hamilton Rating Scale for Anxiety [HAM-A] = 22.0 +/- 3.1 [SD]) and
insomnia were given single-blind placebo for 7 nights. Nine patients whose anxiety and/or
insomnia improved were dropped as placebo responders. The remaining 99 patients were randomly allocated (1:1) to double-blind treatment with either
estazolam 2.0 mg or matching placebo for 7 nights.
Hypnotic efficacy, as determined by patient-completed sleep questionnaires, was statistically significant for
estazolam 2.0 mg versus placebo for all sleep indices (p less than 0.01). Patients treated with
estazolam 2.0 mg showed significantly greater improvement in anxiety than those receiving placebo on the mean total score of HAM-A ([placebo, -3.4;
estazolam, -7.1; p less than 0.001] and without the
insomnia item [placebo, -2.7;
estazolam, -5.5; p less than 0.001]). Anxiety scores on the State-Trait Anxiety Inventory showed greater improvement in the
estazolam group, but without statistical significance (p = 0.237).
Estazolam 2.0 mg is an effective
hypnotic in patients with generalized
anxiety disorder and appears to have a favorable
anxiolytic action.