What is the therapeutic effect of Lebolaysen

Efficacy and safety results were reported in Study E2006-G000-303 (Study 303; SUNRISE-2) in subjects with insomnia who received continuous lemborexant treatment for up to 12 months.

Study 303 (NCT02952820) is a 12-month global, multicenter, randomized, double-blind, parallel-group Phase 3 study divided into two treatment periods. During treatment period 1 (first six months), subjects (n = 949, full analysis set) were randomized to daily placebo, 5 mg leboresen (LEM5), or 10 mg leboresen (LEM10). During the second treatment period (second six months), placebo subjects were rerandomized to LEM5 or LEM10, and subjects randomized to leborexan continued their assigned treatment (LEM5, n=251; LEM10, n=226). Sleep onset and sleep maintenance endpoints were analyzed based on daily electronic sleep diary data. Monitor for treatment-emergent adverse events (TEAEs).

Results: For all sleep parameters, the significant benefits observed at 6 months for LEM5 and LEM10 compared with placebo were maintained at 12 months in subjects who received continuous treatment for 12 months. No patients in either group were found to have rebound insomnia or signs of drug withdrawal after drug withdrawal. Over 12 months of treatment, most TEAEs were mild/moderate; the most common TEAEs were nasopharyngitis, somnolence, and headache.

Conclusions: LEM5 and LEM10 had significant benefits on sleep initiation and sleep maintenance compared with placebo, and importantly, the effectiveness of leborexan persisted after 12 months, suggesting that leborexan may provide long-term benefits for patients with insomnia.

Leborexan is used to treat adult patients characterized by difficulty falling asleep and/or maintaining sleep. It is a dual orexin receptor antagonist that inhibits the wake-promoting effect of orexin by blocking the binding of orexin to orexin 1 and 2 receptors, thereby inducing physiological sleep. Studies have shown that Leborexen is more effective than Suvorexan and Dalidorexen in improving acute and chronic insomnia.

Leborexan is approved in the United States, Canada and other countries for the treatment of adult insomnia. Common adverse reactions are drowsiness and fatigue. The recommended dose of leborexan is 5 mg, taken no more than once each night before bedtime, with at least 7 hours remaining before scheduled awakening time. It is recommended that patients take medication under the guidance of a doctor and receive symptomatic treatment.

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References

Yardley J, Kärppä M, Inoue Y, Pinner K, Perdomo C, Ishikawa K, Filippov G, Kubota N, Moline M. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial. Sleep Med. 2021 Apr;80:333-342. doi: 10.1016/j.sleep.2021.01.048. Epub 2021 Feb 1. PMID: 33636648.