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

Purpose: Studies of Lemborexant (LEM) treatment for patients with insomnia in China in real-world setting have been limited. This study assessed efficacy and safety of LEM in treating Chinese patients with insomnia. Patients and Methods: In this 12-week, multicenter, prospective, observational study, 205 adult patients diagnosed with insomnia with an Insomnia Severity Index (ISI) score of ≥10 were enrolled and treated with LEM in China. The primary endpoint was remission rate (the proportion of patients with an ISI<8) after 4 weeks of LEM treatment. Treatment-emergent adverse events (TEAEs) were recorded. Results: The full analysis set included 200 patients with a mean baseline ISI of 17.44±4.45. Remission rate and responder (≥6-point reduction in ISI) rate after 4 weeks of LEM treatment was 30.5% (61/200) and 55.0% (110/200), respectively. ISI scores decreased significantly from baseline after 1 weeks of treatment and kept decreasing. LEM treatment also improved symptoms of depression and anxiety. Compared with patients with mild insomnia, patients with severe baseline insomnia were less likely to be insomnia remitters and more likely to be LEM responders and to have greater ISI decrease after 4 weeks of treatment. Additionally, patients who switched to LEM from other hypnotics were less likely to be LEM responders than patient receiving initial LEM monotherapy. 21.0% (43/205) of the patients reported at least one mild or moderate TEAE, and none reported serious TEAEs. Ten (4.9%) patients withdrew from the study due to TEAEs. The most common TEAEs were somnolence, dizziness and nightmare. Conclusion: Lemborexant was effective and safe in treating Chinese adult patients with insomnia. Clinicaltrialsgov Registration Number: NCT06225947 (Date of registration: January 17, 2024).