Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysis.

BACKGROUND: Insomnia is a prevalent sleep disorder that significantly impacts quality of life and overall health. Lemborexant, a dual orexin receptor antagonist, has emerged as a promising treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Lemborexant in adults with insomnia. METHODS: We systematically searched PubMed, Embase, Cochrane, and clinicaltrials.gov through March 5, 2025, for randomized controlled trials (RCTs) comparing lemborexant with placebo. Primary outcomes included changes in wake after sleep onset (WASO), sleep efficiency, and sleep onset latency. Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and headache. Data were synthesized using a random-effects model and assessed for heterogeneity. Meta-analyses used a random-effects model and heterogeneity was assessed using the I2 statistic. RESULTS: Six RCTs involving 2257 patients were included. Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to -12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced sleep onset latency (MD: 10.85 min; 95 % CI: 18.47 to -3.23). Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference in overall TEAEs or headache compared to placebo. CONCLUSION: Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety.