Lemborexant, a dual orexin receptor antagonist, significantly improves key sleep parameters in patients with insomnia disorder, including sleep onset latency, wake after sleep onset, and sleep efficiency, according to results presented at the 2025 American Academy of Neurology (AAN) annual meeting and published in Neurology. Insomnia disorder is known to impair daytime functioning and quality of life.
A systematic review and meta-analysis of four studies involving 1,976 patients compared lemborexant (5 mg and 10 mg doses) to placebo for treating insomnia symptoms. Lemborexant was associated with reductions in sleep onset latency (mean difference [MD], -9.23; P = 0.02) and wake after sleep onset (MD, -19.9; P < 0.001). The 10 mg dose showed further improvements in both parameters (MD, -12.56; P = 0.004 and MD, -22.24; P < 0.001, respectively).
However, the analysis also noted higher rates of treatment-emergent adverse events, particularly somnolence, with lemborexant compared to placebo (risk ratios [RRs], 1.94 and 4.95; P < 0.0001 for both). Despite these safety concerns, both doses of lemborexant were deemed effective and generally well-tolerated. The study concluded that while lemborexant fills a therapeutic gap, it should be used cautiously, especially at the 5 mg dose, to mitigate the risk of excessive daytime somnolence.
