drugset / Trial / NCT02839200
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |