drugset / Trial / NCT03679884
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Timeline
- Start
- 2018-10-09
- Primary completion
- 2021-02-22
- Completion
- 2021-02-22
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.
- Kunz D, Dauvilliers Y, Benes H, Garcia-Borreguero D, Plazzi G, Seboek Kinter D, Coloma P, Rausch M, Sassi-Sayadi M, Thein S. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs. 2023 Jan;37(1):93-106. doi: 10.1007/s40263-022-00980-8. Epub 2022 Dec 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daridorexant | Small molecule | 10 mg | Oral |
| Subject | Daridorexant | Small molecule | 25 mg | Oral |
| Subject | Daridorexant | Small molecule | 50 mg | Oral |