Summary

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• This summary is based on the review of 12 systematic review(s)/meta-analysis(es). ^[1-12]
• Latency to Persistent Sleep (LPS): Lemborexant (5 mg and 10 mg) demonstrated moderate to high certainty in reducing LPS, with significant reductions observed compared to placebo. This effectiveness is comparable to other drugs like suvorexant and daridorexant.
• Wake Time After Sleep Onset (WASO) and Total Sleep Time (TST): Lemborexant (5 mg and 10 mg) significantly reduced WASO, with the 10 mg dose providing the largest reduction at month 1. It was also effective in increasing TST, with the 10 mg dose showing higher effectiveness, comparable to suvorexant and daridorexant.
• Insomnia Severity Index (ISI) and Morning Alertness: Lemborexant showed improvement in ISI scores, indicating a reduction in insomnia severity, along with enhancements in morning alertness compared to placebo.
• Comparison to Other Drugs: Lemborexant outperformed other hypnotics like zopiclone in terms of sleep efficiency and showed superior efficacy in subjective sleep outcomes compared to suvorexant. It also had a lower incidence of dropouts due to adverse events, further supporting its favorable safety and effectiveness profile.
• Somnolence and Dizziness: Lemborexant (5 mg and 10 mg) commonly caused somnolence, which was more frequent compared to placebo. Dizziness and headaches were also prevalent side effects. These adverse events are similar to those observed with other drugs, including suvorexant.
• Infections: Upper respiratory tract infections and urinary tract infections were noted as side effects of lemborexant. However, there were no statistically significant or clinically relevant adverse effects on driving performance, unlike some other hypnotics.
• Comparison with Other Hypnotics: Lemborexant had similar rates of adverse events, such as somnolence and nasopharyngitis, compared to suvorexant. Zopiclone and zolpidem were associated with higher rates of dropouts due to adverse events compared to lemborexant.
• Lemborexant has been evaluated in several population subgroups, including patients with psychiatric disorders (e.g., depression and bipolar disorder), older adults, and those with mild-to-moderate Alzheimer’s disease. The drug demonstrated similar treatment effects across older and adult populations, with a broadly similar safety profile across age groups. Additionally, lemborexant was found to be effective and safe for treating insomnia comorbid with psychiatric disorders, showing beneficial effects on sleep outcomes without significant adverse effects in patients with dementia.