How effective is the new drug Lemborexant for treating insomnia?

The effect of Leborexant in the treatment of insomnia is obvious. Compared with placebo, lemborexant has a significant increase in total sleep time compared with baseline, a significant increase in REM sleep time compared with baseline, and a significant decrease in latency to REM sleep compared with baseline. These findings suggest that lemborexant treatment may address changes in sleep architecture in some patients with insomnia.

Curative effect

Lemborexant is a dual orexin receptor antagonist approved in the United States, Japan and Canada for the treatment of insomnia in adults. In one trial investigating the effectiveness of leborexant, during treatment phase 1 (first 6 months), subjects (n = 949, full analysis set) were randomly assigned to daily placebo, lemborexant 5 mg (LEM5) or lemborexant 10 mg (LEM10). In treatment period 2 (second six months), placebo subjects were rerandomized to LEM5 or LEM10, and subjects were randomly assigned to continue treatment with lemborexant (LEM5, n = 251; LEM10, n = 226). Onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Monitor for treatment-emergent adverse events (teae).

Results: For all sleep parameters, the significant benefits observed during 6 months for LEM5 and LEM10 compared with placebo were maintained at 12 months in subjects who received continuous treatment for 12 months. There was no evidence of rebound insomnia or withdrawal symptoms after discontinuation of treatment in either lemborexant group. After 12 months of lemborexant treatment, most teae were mild/moderate.

Conclusions: LEM5 and LEM10 had significant benefits on sleep initiation and sleep maintenance compared with placebo, and the effects of lemborexant were sustained for 12 months, suggesting that lemborexant may provide long-term benefits for patients with insomnia. 2015-001463-39.

The recommended oral dose of leborexan is 5 mg, taken before going to bed, and no more than once a day at night. Pay attention to the taking time of the drug. If taken with or shortly after a meal, the time to fall asleep may be delayed. It is not recommended for patients with severe liver damage.

The maximum recommended dose of leborexan is 10 mg once daily. In case of overdose, the frequency increases in a dose-dependent manner.

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