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Results of phase III SUNRISE 1 study of Dayvigo in insomnia published in JAMA Network Open journal.- Eisai

Read time: 1 mins
Published:30th Dec 2019
Eisai announced that JAMA Network Open (www.jamanetwork.com) published results of SUNRISE 1 (Study 304), a pivotal Phase III head-to-head study that compared Dayvigo (lemborexant) to placebo and an active comparator in patients with insomnia disorder. In this study, Dayvigo therapy significantly improved both sleep onset and sleep maintenance compared with placebo. Comment: Dayvigo was approved by the FDA on December 20, 2019 for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The FDA has recommended that Dayvigo be classified as a controlled substance and this recommendation has been submitted to the U.S. Drug Enforcement Administration.See: "Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase III Randomized Clinical Trial" Russell Rosenberg et al. JAMA Netw Open. 2019; 2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254
Condition: Sleeping Disorders/ ISWRD
Type: drug

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