Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

Summary

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Timeline

Start

2016-10-04

Primary completion

2017-04-12

Completion

2017-06-20

Outcome

Met primary endpoint

registry ACT-541468 50 mg vs Placebo; p < 0.001; LS Mean difference -25.6 (95% CI -37.3 to -13.9); ANCOVA NCT02839200 ↗

paper A significant dose-response relationship (multiple comparison procedure-modeling, 2-sided p < 0.001) was found in the reduction of wake after sleep onset PMID 31953863 ↗

Publications

• Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
• Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
• Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	5 mg	Oral
Subject	Daridorexant	Small molecule	10 mg	Oral
Subject	Daridorexant	Small molecule	25 mg	Oral
Subject	Daridorexant	Small molecule	50 mg	Oral
Comparator	Zolpidem	Small molecule	10 mg	Oral

Indications