drugset / Trial / NCT03545191
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Timeline
- Start
- 2018-06-04
- Primary completion
- 2020-01-25
- Completion
- 2020-02-25
Outcome
Met primary endpoint
registry Daridorexant 25 mg vs Placebo; p <0.0001; LS mean difference to placebo -12.20 NCT03545191 ↗
registry Daridorexant 25 mg vs Placebo; p <0.0001; LS mean difference to placebo -11.86 NCT03545191 ↗
registry Daridorexant 25 mg vs Placebo; p = 0.0005; LS mean difference to placebo -8.32 NCT03545191 ↗
registry Daridorexant 25 mg vs Placebo; p = 0.0015; LS mean difference to placebo -7.59 NCT03545191 ↗
Publications
- Background Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
- Results Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
- Schaedel Z, Bakker TR, Bassetti C, Briasoulis O, Cassel P, Pain S, Palacios S, Palmay C, Silvestri R, Stute P, Tremollieres F, Bertisch SM. Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial. Maturitas. 2026 Mar;206:108821. doi: 10.1016/j.maturitas.2025.108821. Epub 2025 Dec 23.
- Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, Tjiptarto N, Arslan A, Hubbard J, Olivieri A, Puryear CB, Brandon Westover M, Donoghue J. The Insomnia EEG Score: a new tool for the classification of people with poor sleep. Sleep. 2026 Apr 16;49(4):zsaf353. doi: 10.1093/sleep/zsaf353.
- Lettieri CJ, Briasoulis O, Leger D, Luyet PP, Pepin JL, Quan SF, Raphelson J, Saskin P, Malhotra A. The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial. J Sleep Res. 2026 Apr;35(2):e70135. doi: 10.1111/jsr.70135. Epub 2025 Jul 14.
- Dauvilliers Y, Braunstein G, Zammit G, Olivieri A, Luyet PP. Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder. Sleep Med. 2025 Jul;131:106523. doi: 10.1016/j.sleep.2025.106523. Epub 2025 Apr 17.
- Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.
- Phillips-Beyer A, Kawata AK, Kleinman L, Seboek Kinter D, Flamion B. Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials. Pharmaceut Med. 2024 Mar;38(2):133-144. doi: 10.1007/s40290-023-00512-9. Epub 2024 Feb 1.
- Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
- 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.
- Phillips-Beyer A, Kawata AK, Kleinman L, Kinter DS. Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant. Pharmaceut Med. 2023 Jul;37(4):291-303. doi: 10.1007/s40290-023-00484-w. Epub 2023 Jun 7.
- Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
- Heidenreich S, Ross M, Chua GN, Seboek Kinter D, Phillips-Beyer A. Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials. Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daridorexant | Small molecule | 25 mg | Oral |
| Subject | Daridorexant | Small molecule | 50 mg | Oral |