Daridorexant 50 mg

DRUG11 trials

Conditions

AddictionAlzheimer DiseaseAlzheimer Disease (AD)Cognitive FunctioningEmotional ProcessingHealthyInsomniaInsomnia 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

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

Daridorexant to Prevent Delirium After Heart Surgery

CompletedNCT06630390

University of RochesterPOSTOPERATIVE COGNITIVE DECLINE, POSTOPERATIVE DELIRIUM

Start: 2024-11-11End: 2025-02-16Updated: 2025-07-11

Daridorexant for Alzheimer Disease Prevention

RecruitingNCT07213349

Douglas Mental Health University InstituteAlzheimer Disease (AD)

Start: 2025-10-14End: 2029-12-31Target: 240Updated: 2025-12-19

Daridorexant to Prevent Post-cardiotomy Delirium

RecruitingNCT07217912

University of RochesterPostoperative Cognitive Decline, Postoperative Delirium

Start: 2025-10-14End: 2027-11-01Target: 80Updated: 2026-01-07

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

Phase 4

Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

RecruitingNCT05924425

University Hospital, MontpellierAlzheimer Disease, Insomnia Disorder, Sleep

Start: 2024-03-13End: 2027-03-13Target: 62Updated: 2024-04-11

Dual Orexin Antagonism and Emotion and Affective Processing Study

RecruitingNCT07267559

University of OxfordCognitive Functioning, Emotional Processing, Learning

Start: 2025-10-01End: 2026-10-01Target: 62Updated: 2026-03-19

Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking

Not yet recruitingNCT07328594

Legacy Health SystemAddiction, Insomnia, Nicotine +4

Start: 2026-02-10End: 2027-09-30Target: 44Updated: 2026-01-09

Unknown Phase

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

Enrolling by invitationNCT06311864

PeriPharmInsomnia

Start: 2024-06-20End: 2025-10-31Target: 100Updated: 2025-03-17

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 &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