Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

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

2018-05-29

Primary completion

2020-04-09

Completion

2020-05-14

Outcome

Mixed primary results

registry analysis (other test); Daridorexant 25 mg vs Placebo; p = 0.0001; LS mean difference to placebo -11.62 (95% CI -17.604 to -5.633) NCT03575104 ↗

registry analysis (other test); Daridorexant 10 mg vs Placebo; p = 0.3669; LS mean difference to placebo -2.74 (95% CI -8.693 to 3.215) NCT03575104 ↗

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.
• 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.
• 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.
• 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.
• 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	10 mg	Oral
Subject	Daridorexant	Small molecule	25 mg	Oral

Indications