How effective is leborexin in treating insomnia?

Insomnia is a common sleep-wake disorder associated with severe functional impairment and increased health care costs. Currently, drugs that can be used to treat insomnia include gamma-aminobutyric acid type A receptor agonists, melatonin receptor agonists, sedative antidepressants, sedative antihistamines, and dual orexin receptor antagonists. (lem borexant) was developed by Japan's Eisai Company and was approved by the U.S. Food and Drug Administration (FDA) for marketing on December 20, 2019. The trade name is Dayvigo. It is used to treat insomnia in adults who have difficulty in starting and/or maintaining sleep. So, how effective is leborexin in treating insomnia?

The effect of leborexan in treating insomnia

The efficacy and safety of Leborexane were evaluated in two clinical trials (Study 1 and 2). Study 1 was a 6-month, randomized, double-blind, placebo-controlled, multicenter clinical trial of 949 patients with once-nightly dosing (5 mg or 10 mg).

The results showed that at the end of the clinical trial, patients' sleep onset latency was significantly shortened, sleep maintenance time was significantly increased, and subjective awakening after sleep onset was significantly improved; Study 2 was a clinical trial on 1,003 adult female patients aged 55 and above and male patients aged 65 and above who met the criteria for insomnia disorder. The drug was administered once nightly (5 mg or 10 mg). The results showed that at the end of the clinical trial, leborexan relieved patients' symptoms of difficulty in sleep initiation and/or sleep maintenance to a greater extent than the placebo group. The most common adverse reactions of leborexan are drowsiness and nightmares.

Other experiments

The results of a 1-year phase III clinical trial involving 1,959 patients with moderate to severe insomnia proved that leborexan can continuously relieve insomnia symptoms for 12 months. Among them, 80% of patients with moderate insomnia and most of the patients with severe insomnia significantly alleviated the severity of insomnia and reduced symptoms to sub-clinical levels after 6 to 12 months of leborexant treatment, with good tolerance [1].

References

[1] Hu Hongyu, Hu Chun. Lemborexant, Dayvigo[J]. Chinese Journal of Medicinal Chemistry, 2020, 30(11):711.DOI:10.14142/j.cnki.cn21-1313/r.2020.11.011.

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