Patient-Reported Outcomes for LEMborexant Treatment in Chinese Patients with Insomnia (PROEM): A Multicenter,...

Area of Science:

• Pharmacology
• Sleep Medicine
• Clinical Research

Background:

• Limited real-world data exists on Lemborexant (LEM) for insomnia treatment in China.
• Assessing LEM's efficacy and safety in a diverse Chinese patient population is crucial.

Purpose of the Study:

• To evaluate the efficacy and safety of Lemborexant (LEM) in adult patients with insomnia in a real-world Chinese setting.
• To determine the remission and responder rates of LEM treatment over 12 weeks.

Main Methods:

• A 12-week, multicenter, prospective, observational study.
• 205 adult patients with insomnia (Insomnia Severity Index [ISI] score ≥10) received LEM.
• Primary endpoint: remission rate (ISI < 8) at 4 weeks; safety assessed via treatment-emergent adverse events (TEAEs).

Main Results:

• After 4 weeks, the remission rate was 30.5% and the responder rate (≥6-point ISI reduction) was 55.0%.
• Significant ISI score reduction observed from week 1, with sustained improvement.
• LEM improved depression and anxiety symptoms; severe insomnia patients showed different response patterns. Most TEAEs were mild (somnolence, dizziness, nightmare).

Conclusions:

• Lemborexant (LEM) demonstrated significant efficacy and a favorable safety profile for treating insomnia in Chinese adults.
• The study provides valuable real-world evidence supporting LEM's use in this population.
• LEM offers a viable treatment option, improving sleep quality and associated symptoms.