Loading clinical trials...

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

NCT07028697•Nxera Pharma Korea Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent prior to any study-mandated procedure;
•Male or female aged ≥ 19 years;
•Insomnia disorder according to DSM-5 criteria;
•The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
•Difficulty initiating sleep.
•Difficulty maintaining sleep (characterized by frequent awakenings or problems returning to sleep after awakenings).
•Early-morning awakening with inability to return to sleep.
•Insomnia Severity Index score ≥ 15;
•Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h

Exclusion Criteria

•Body mass index (BMI) ≥ 40.0 kg/m2
•Documented medical history and/or comorbidity of sleep-related breathing disorder
•History of and/or concurrent sleep apnea or suspected sleep apnea
•Korean-Mini Mental State Examination-2 (K-MMSE-2) score \< 25 in subjects ≥ 50 years;
•For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
•Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
•A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
•Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.

Locations (17)

Inje University Busan Paik Hospital

Busan, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Catholic Kwandong University International St. Mary'S Hospital

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Key Dates

Start Date

December 4, 2024

Primary Completion Date

September 23, 2025

Completion Date

October 21, 2025

Last Updated

January 21, 2026

Enrollment

164

ACTUAL participants

Conditions

Insomnia Disorder

Interventions

Daridorexant

DRUG

Placebo

DRUG

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

NCT05780177

Posttraumatic Stress DisorderInsomnia Disorder

View study

RECRUITINGNA

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

NCT06779149

Insomnia Disorder

View study

COMPLETEDNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Inclusion Criteria

Exclusion Criteria

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

Cultural Adaptation of CBTi for the Arab World

Changed Serum Levels of Sirtuin1 and Sirtuin3 and Their Correlations With Sleep Quality and Cognitive Function in the Patients With Chronic Insomnia Disorder

Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

Digital CBT-I for Insomnia Disorder