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ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:18 AM EDT

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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Daridorexant Clear all
Completed Phase 3 Interventional Results available

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

NCT03679884
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years and older
Enrollment
804 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
53
States / cities
Birmingham, Alabama • Glendale, Arizona • Tucson, Arizona + 47 more
Source: ClinicalTrials.gov public record
Updated Mar 2, 2022 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

NCT02839200
View directory record Official record
Conditions
Insomnia Disorder
Interventions
ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg, Zolpidem, Placebo 1, Placebo 2
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years to 64 Years
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
15
States / cities
Santa Monica, California • Upland, California • Brandon, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2020 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder

NCT02841709
View directory record Official record
Conditions
Insomnia Disorder
Interventions
ACT-541468, Placebo
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
65 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
5
States / cities
Brandon, Florida • Chicago, Illinois • Las Vegas, Nevada + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 24, 2020 · Synced Oct 19, 2026, 10:18 AM EDT
Recruiting No phase listed Observational

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

NCT06498128
View directory record Official record
Conditions
Insomnia
Interventions
Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
Drug · Other
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
15 Years to 50 Years · Female only
Enrollment
785 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2033
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 2, 2025 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

NCT05632393
View directory record Official record
Conditions
Healthy
Interventions
Daridorexant
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated May 12, 2023 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

NCT03545191
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Daridorexant 25 mg, Daridorexant 50 mg, Placebo
Drug · Other
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years and older
Enrollment
930 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
36
States / cities
Anniston, Alabama • Birmingham, Alabama • Little Rock, Arkansas + 33 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2022 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03575104
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Daridorexant, Placebo
Drug · Other
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years and older
Enrollment
924 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
37
States / cities
Glendale, Arizona • Tucson, Arizona • Little Rock, Arkansas + 33 more
Source: ClinicalTrials.gov public record
Updated Mar 25, 2022 · Synced Oct 19, 2026, 10:18 AM EDT
Not yet recruiting Phase 2 Interventional

Daridorexant for People With Insomnia and Alcohol Use Disorder Study

NCT07701928
View directory record Official record
Conditions
Alcohol Use Disorder, Insomnia
Interventions
Daridorexant, Placebo, Brief Counseling, MEMS and Medication Accounting, Contingency Management for Medication Adherence
Drug · Behavioral · Device
Lead sponsor
Sterling McPherson
Other
Eligibility
18 Years and older
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
Spokane, Washington
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Suspended Phase 2 Interventional Accepts healthy volunteers

Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

NCT05948540
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Intervention C Daridorexant, Intervention C Placebo
Drug
Lead sponsor
Global Coalition for Adaptive Research
Other
Eligibility
18 Years to 65 Years
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2029
U.S. locations
9
States / cities
Miami, Florida • Atlanta, Georgia • Tripler AMC, Hawaii + 6 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT05877222
View directory record Official record
Conditions
Healthy
Interventions
Daridorexant 10 mg, Daridorexant 25 mg
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years to 65 Years
Enrollment
38 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Anaheim, California
Source: ClinicalTrials.gov public record
Updated Aug 16, 2023 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 4 Interventional Results available

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

NCT05597020
View directory record Official record
Conditions
Insomnia Disorder, Nocturia
Interventions
Daridorexant, Placebo
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
55 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
5
States / cities
Miami Beach, Florida • Pompano Beach, Florida • Weston, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2025 · Synced Oct 19, 2026, 10:18 AM EDT
Recruiting Phase 2 Interventional

Daridorexant to Prevent Post-cardiotomy Delirium

NCT07217912
View directory record Official record
Conditions
Postoperative Cognitive Decline, Postoperative Delirium
Interventions
Daridorexant 50 mg, Placebo
Drug · Other
Lead sponsor
University of Rochester
Other
Eligibility
60 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jan 7, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Not yet recruiting Phase 4 Interventional

Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking

NCT07328594
View directory record Official record
Conditions
Smoking, Nicotine, Tobacco, Addiction, Substance Use Disorders, Insomnia, Sleep
Interventions
Daridorexant 50 mg, Placebo
Drug · Other
Lead sponsor
Legacy Health System
Other
Eligibility
18 Years to 55 Years
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Jan 9, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Recruiting Phase 4 Interventional

Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

NCT07136415
View directory record Official record
Conditions
Menopausal Women, Insomnia
Interventions
Cognitive behavioral therapy for insomnia (CBT-i), Trazodone, Daridorexant
Behavioral · Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
40 Years to 62 Years · Female only
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
5
States / cities
Boston, Massachusetts • Novi, Michigan • Winston-Salem, North Carolina + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

NCT03657355
View directory record Official record
Conditions
Healthy Recreational Drug Users
Interventions
ACT-541468, Suvorexant, Zolpidem, Placebo
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
18 Years to 55 Years
Enrollment
63 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 19, 2019 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 2 Interventional Results available

Daridorexant to Prevent Delirium After Heart Surgery

NCT06630390
View directory record Official record
Conditions
POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE
Interventions
Daridorexant 50 mg, Placebo
Drug · Other
Lead sponsor
University of Rochester
Other
Eligibility
60 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jul 11, 2025 · Synced Oct 19, 2026, 10:18 AM EDT
Active, not recruiting No phase listed Observational

Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

NCT06393504
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
Drug · Other
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
15 Years to 50 Years · Female only
Enrollment
2,095 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
Wilmington, Delaware
Source: ClinicalTrials.gov public record
Updated Aug 19, 2025 · Synced Oct 19, 2026, 10:18 AM EDT
Completed Phase 2 Interventional

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

NCT05423717
View directory record Official record
Conditions
Insomnia
Interventions
Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo
Drug
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Eligibility
10 Years to 17 Years
Enrollment
166 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
12
States / cities
Tucson, Arizona • Little Rock, Arkansas • Brandon, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Mar 6, 2026 · Synced Oct 19, 2026, 10:18 AM EDT
Suspended Phase 2 Interventional Accepts healthy volunteers

Department of Defense PTSD Adaptive Platform Trial - Master Protocol

NCT05422612
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Intervention A Fluoxetine Hydrochloride (HCl), Intervention A Placebo, Intervention B Vilazodone Hydrochloride (HCl), Intervention B Placebo, Intervention C Daridorexant, Intervention C Placebo, Intervention D SLS-002, Intervention D Placebo
Drug
Lead sponsor
Global Coalition for Adaptive Research
Other
Eligibility
18 Years to 65 Years
Enrollment
800 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2029
U.S. locations
9
States / cities
Miami, Florida • Atlanta, Georgia • Tripler AMC, Hawaii + 6 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Oct 19, 2026, 10:18 AM EDT