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Daridorexant, a new dual orexin receptor antagonist to treat insomnia disorder

Annals of Neurology Jan 24, 2020

Dauvilliers Y, Zammit G, Fietze I, et al. - In patients with insomnia disorder, researchers conducted this randomized, double-blind, placebo-controlled and active-controlled dose-response phase 2 study to test the safety and effectiveness of daridorexant, a new dual orexin receptor antagonist, on objective and subjective sleep parameters. This investigation was carried out at 38 sites in 6 countries at hospitals and sleep centers in Germany, Hungary, Israel, Spain, Sweden, and the US. For this analysis, study participants (≤ 64 years) with insomnia disorder were randomized (1:1:1:1:1:1) to receive daily oral placebo, daridorexant (5, 10, 25, or 50 mg), or 10 mg zolpidem for 30 days. A total of 1,005 patients were screened between October 4, 2016, and June 20, 2017. In patients with insomnia disorder, daridorexant induced a dose-dependent reduction in wake time after sleep onset. There have been no serious adverse events associated with clinically relevant treatment.
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