Lemborexant Effective in Improving Sleep Symptoms in Insomnia Disorder

Treatment with lemborexant vs placebo improves sleep onset latency, wake after sleep onset, and sleep efficiency in patients with insomnia disorder, according study results presented at the 2025 American Academy of Neurology (AAN) annual meeting, held from April 5 to 9, 2025, in San Diego, California, and published in the journal Neurology.                 

Insomnia disorder has shown to result in poor daytime functioning and a decreased quality of life. 

Researchers of a systematic review and meta-analysis aimed to determine the safety and efficacy of lemborexant in the treatment of insomnia symptoms, such as sleep onset and maintenance of sleep.

The researchers collected data on the safety and efficacy of lemborexant vs placebo for the treatment of insomnia from multiple databases until September 2024. Using RevMan, the researchers pooled dichotomous and continuous data. The ROB2 methodology was used to determine quality of the evidence.

A total of 4 studies with 1976 patients were included in the analysis.

Lemborexant vs placebo was found to decrease sleep onset latency and wake after sleep onset (MD, -9.23; P =.02 and MD, -19.9; P <.001), with both 5 mg and 10 mg lemborexant (MD, -12.56; P =.004 and MD, -22.24; P <.001, respectively).

With regard to safety, lemborexant vs placebo showed significantly higher treatment-emergent adverse events (TEAEs) and somnolence (risk ratios [RRs], 1.94 and 4.95; P <.0001 for both).

Overall, both doses of lemborexant vs placebo were effective and well-tolerated to treat sleep symptoms in patients with insomnia.

“Lemborexant appears to fill a therapeutic gap in the treatment of insomnia but should be used with care and smaller dose (5 mg) in those who are at risk of developing an excessive day time somnolence state,” the researchers concluded.