Zuranolone shows promise for insomnia

The investigational drug zuranolone (SAGE-217) appears to improve multiple aspects of sleep when administered to transient insomnia-induced individuals, according to the results of a phase I study.

Researchers used a 5-h phase advance model of transient insomnia and evaluated the efficacy of the drug in 45 healthy adults (mean age 37.1 years, 60 percent male). These participants were randomized in a three-way crossover design to receive zuranolone 30 mg, zuranolone 45 mg, or placebo; 36 (80 percent) completed all periods of the study. They underwent polysomnography and completed a postsleep questionnaire.

Compared with placebo, zuranolone 30 and 45 mg produced marked improvements in median sleep efficiency (84.6 percent and 87.6 percent vs 72.9 percent; p<0.001 for both doses), wake after sleep onset (55.0 and 42.5 min vs 113.0 min; p<0.001 for both doses), duration of awakenings (4.2 and 3.7 min vs 7.4 min; p<0.001 and p=0.001), and total sleep time (406.3 and 420.3 min vs 350.0 min; p<0.001 for both doses).

Zuranolone also showed superiority over placebo in terms of subjective endpoints, including sleep latency and sleep quality.

The investigational drug was generally safe and well tolerated. Headache and fatigue were the most common adverse events.

The findings support the further examination of zuranolone in patients with insomnia alone or with comorbid major depressive disorder.