Long-term safety and efficacy of vornorexant in Japanese patients with insomnia: A 52-week open-label, randomized trial.
Naohisa Uchimura, Daiji Kambe, Sayaka Hasegawa et al.
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In 30 seconds
This multicenter, randomized, open-label trial evaluated the long-term safety and efficacy of vornorexant in 371 Japanese patients with insomnia over 52 weeks. The study found that vornorexant was well tolerated, with no clinically concerning withdrawal symptoms or rebound insomnia. Significant improvements in sleep onset and maintenance were observed, with mean changes in subjective sleep latency of -31.2 and -38.9 minutes for VOR5 and VOR10 at week 26, respectively.
Key findings
- Mean change from baseline in subjective sleep latency was -31.2 min for VOR5 and -38.9 min for VOR10 at week 26.
- Mean change in subjective sleep efficiency was 14.07% for VOR5 and 17.63% for VOR10 at week 26.
- No clinically concerning withdrawal symptoms or rebound insomnia were detected during the study.
Why it matters
Understanding the long-term safety and efficacy of insomnia treatments is crucial for clinicians to make informed decisions about managing patients with sleep disorders, particularly in specific populations such as Japanese patients.