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Daridorexant 25 mg

DRUG5 trials

Sponsors

Idorsia Pharmaceuticals Ltd.

Conditions

HealthyInsomniaInsomnia Disorder

Phase 1

A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented
CompletedNCT05702177
Idorsia Pharmaceuticals Ltd.Healthy
Start: 2023-01-05End: 2023-04-25Updated: 2023-05-12
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
CompletedNCT05877222
Idorsia Pharmaceuticals Ltd.Healthy
Start: 2023-06-23End: 2023-08-04Updated: 2023-08-16

Phase 2

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
CompletedNCT05423717
Idorsia Pharmaceuticals Ltd.Insomnia
Start: 2022-09-06End: 2026-02-05Updated: 2026-03-06

Phase 3

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
CompletedNCT03545191
Idorsia Pharmaceuticals Ltd.Insomnia Disorder
Start: 2018-06-04End: 2020-02-25Updated: 2022-03-25
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
CompletedNCT03679884
Idorsia Pharmaceuticals Ltd.Insomnia Disorder
Start: 2018-10-09End: 2021-02-22Updated: 2022-03-02

Related Papers

Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial.
2025-12-23
Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial.
Open Access CRIS of the University of Bern2025-12-23
Patient preferences for the benefits and risks of insomnia medication in a clinical trial and real-world setting
Sleep Science and Practice2025-12-10
The Insomnia EEG Score: a new tool for the classification of people with poor sleep
SLEEP2025-11-112 citations
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
Journal of Sleep Research2025-07-141 citations
3052 Efficacy and safety of daridorexant in patients &amp;gt;65 years with insomnia
Age and Ageing2025-07-01
Time to therapeutic effect with daridorexant: Weekly analysis of patient-reported outcomes from a Phase 3 randomized, placebo-controlled study in patients with insomnia disorder
European Psychiatry2025-04-01
Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function
Journal of Psychopharmacology2024-12-062 citations
Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies
SLEEP2024-04-2210 citations
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.
2024-02-015 citations
P4 Daridorexant improves total sleep time (TST) in insomnia patients without altering the proportion of sleep stages
Abstracts2023-10-01
Lemborexant and Daridorexant for the Treatment of Insomnia
The Journal of Clinical Psychiatry2023-09-285 citations
Understanding daytime functioning in insomnia: responder and correlation analyses in patients treated with daridorexant
Sleep Science and Practice2023-09-191 citations
Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem.
2023-07-2110 citations
Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis.
2023-07-011 citations
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant.
2023-06-073 citations
Key results from two phase 3 trials on the efficacy and safety of daridorexant in patients with chronic insomnia disorder:a plain language summary
Future Neurology2023-05-04
Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.
2022-12-0938 citations
Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial.
2022-09-1322 citations
0455 The Insomnia Daytime Symptoms and Impacts Questionnaire: An Analysis of Clinically Meaningful Change Using Phase 3 Clinical Trial Data
SLEEP2022-05-253 citations

6 more papers not shown