Daridorexant Clinical Trials (2026): 31 Studies for Insomnia Disorder & Healthy
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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31 Daridorexant clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 15 indications (including Insomnia Disorder & Healthy) and 9,276 total planned enrollment. 5 Phase 3 Daridorexant trials and 7 Phase 2, 6 Phase 4 are listed. 11 Daridorexant clinical trials are actively recruiting at 24 U.S. sites across 14 states. Most recent activity: NCT06498128 (Mar 2033).
Where to Participate: All Daridorexant Trial Sites in the U.S. (24 sites across 14 states)
Every actively recruiting Daridorexanttrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| FL | Homestead Associates in Research, Inc. | Miami33032 | NCT05422612 | Map |
| FL | Homestead Associates in Research, Inc. | Miami33032 | NCT05948540 | Map |
| GA | Advanced Discovery Research | Atlanta30318 | NCT05422612 | Map |
| GA | Advanced Discovery Research | Atlanta30318 | NCT05948540 | Map |
| HI | Tripler Army Medical Center (TAMC) | Tripler AMC96859 | NCT05422612 | — |
| HI | Tripler Army Medical Center (TAMC) | Tripler AMC96859 | NCT05948540 | — |
| KY | Cincinnati Veteran's Affairs Medical Center | Fort Thomas41075 | NCT05422612 | Map |
| KY | Cincinnati Veteran's Affairs Medical Center | Fort Thomas41075 | NCT05948540 | Map |
| MD | Walter Reed National Military Medical Center (WRNMC) | Bethesda20889-5632 | NCT05422612 | Map |
| MD | Walter Reed National Military Medical Center (WRNMC) | Bethesda20889-5632 | NCT05948540 | Map |
| MA | Brigham and Women's Hospital | Boston02120 | NCT07136415 | Map |
| MI | Henry Ford Medical Center | Novi48377 | NCT07136415 | Map |
| NY | University of Rochester Medical Center | Rochester14642 | NCT07217912 | Map |
| NY | Upstate Clinical Research Associates, LLC | Williamsville14221 | NCT05422612 | Map |
| NY | Upstate Clinical Research Associates, LLC | Williamsville14221 | NCT05948540 | Map |
| NC | IQVIA US Office | Durham27703 | NCT06498128 | Map |
| PA | University of Pittsburgh Medical Center | Pittsburgh15213 | NCT07136415 | Map |
| TX | Wilford Hall Ambulatory Surgical Center (WHASC) | San Antonio78236 | NCT05422612 | Map |
| TX | Wilford Hall Ambulatory Surgical Center (WHASC) | San Antonio78236 | NCT05948540 | Map |
| UT | University of Utah | Salt Lake City84108 | NCT07136415 | Map |
| VA | Alexander T. Augusta Military Medical Center (ATAMMC): | Fort Belvoir22060-5285 | NCT05422612 | Map |
| VA | Alexander T. Augusta Military Medical Center (ATAMMC): | Fort Belvoir22060-5285 | NCT05948540 | Map |
| WA | Madigan Army Medical Center | Joint Base Lewis McChord98433 | NCT05422612 | Map |
| WA | Madigan Army Medical Center | Joint Base Lewis McChord98433 | NCT05948540 | Map |
Daridorexant clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|---|
| P1 | 9 | 9 | |||
| P2 | 4 | 2 | 1 | 7 | |
| P3 | 5 | 5 | |||
| P4 | 3 | 1 | 2 | 6 | |
| N/A | 1 | 1 | 2 | 4 |
Recruiting Daridorexant clinical trials (11)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06498128 | Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® | — | Insomnia | 785 | Nov 2024 |
| NCT07136415 | CELESTEComparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms | P4 | Menopausal Women | 1,000 | Feb 2026 |
| NCT07532252 | Daridorexant for Alcohol Use Disorder | P2 | Alcohol Use Disorder | 150 | Jan 2027 |
| NCT07213349 | PAD-DORADaridorexant for Alzheimer Disease Prevention | P2 | Alzheimer Disease (AD) | 240 | Oct 2025 |
| NCT05948540 | Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant | P2 | Post Traumatic Stress Disorder | 200 | Nov 2023 |
| NCT05422612 | Department of Defense PTSD Adaptive Platform Trial - Master Protocol | P2 | Post Traumatic Stress Disorder | 800 | Nov 2023 |
| NCT07555743 | Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia | P4 | Insomnia | 134 | Apr 2026 |
| NCT05924425 | DARIDOR-ALZDaridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease | P4 | Alzheimer Disease | 62 | Mar 2024 |
| NCT07217912 | Daridorexant to Prevent Post-cardiotomy Delirium | P2 | Postoperative Cognitive Decline | 80 | Oct 2025 |
| NCT07328594 | Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking | P4 | Smoking | 44 | Feb 2026 |
| NCT07267559 | DOREADual Orexin Antagonism and Emotion and Affective Processing Study | P4 | Learning | 62 | Oct 2025 |
Daridorexant clinical trials by indication
Insomnia Disorder (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06393504 | — | N/A | active not recruiting | Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) |
| NCT07028697 | — | P3 | completed | A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder |
| NCT06010693 | — | P3 | completed | A Study of Daridorexant in Chinese Patients With Insomnia Disorder |
| NCT05597020 | — | P4 | completed | A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia |
| NCT03679884 | — | P3 | completed | Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep |
| NCT03575104 | — | P3 | completed | Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep |
| NCT03545191 | — | P3 | completed | Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder |
Healthy (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05877222 | — | P1 | completed | 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 |
| NCT05632393 | — | P1 | completed | A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women |
| NCT05702177 | — | P1 | completed | 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 |
| NCT05480488 | — | P1 | completed | A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects |
| NCT05480475 | — | P1 | completed | A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects |
| NCT04250506 | — | P1 | completed | A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects |
| NCT04390334 | — | P1 | completed | A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. |
Insomnia (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06498128 | — | N/A | recruiting | Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® |
| NCT07555743 | — | P4 | not yet recruiting | Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia |
| NCT06311864 | — | N/A | completed | Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada |
| NCT05423717 | — | P2 | completed | Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder |
Post Traumatic Stress Disorder (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05948540 | — | P2 | recruiting | Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant |
| NCT05422612 | — | P2 | recruiting | Department of Defense PTSD Adaptive Platform Trial - Master Protocol |
Alcohol Use Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07532252 | — | P2 | not yet recruiting | Daridorexant for Alcohol Use Disorder |
Menopausal Women (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07136415 | CELESTE | P4 | recruiting | Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms |
Smoking (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07328594 | — | P4 | not yet recruiting | Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking |
Alzheimer Disease (AD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07213349 | PAD-DORA | P2 | recruiting | Daridorexant for Alzheimer Disease Prevention |
Postoperative Cognitive Decline (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07217912 | — | P2 | recruiting | Daridorexant to Prevent Post-cardiotomy Delirium |
Learning (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07267559 | DOREA | P4 | recruiting | Dual Orexin Antagonism and Emotion and Affective Processing Study |
POSTOPERATIVE DELIRIUM (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06630390 | — | P2 | completed | Daridorexant to Prevent Delirium After Heart Surgery |
Alzheimer Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05924425 | DARIDOR-ALZ | P4 | recruiting | Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease |
Insomnia Chronic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07132086 | — | N/A | completed | Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting |
Healthy Volunteer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06326723 | — | P1 | completed | Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects |
Obstructive Sleep Apnea of Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05458193 | — | P1 | completed | A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep |
Daridorexant pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| CELESTE | NCT07136415 | P4 | recruiting | Menopausal Women | 1,000 | — |
| DARIDOR-ALZ | NCT05924425 | P4 | recruiting | Alzheimer Disease | 62 | — |
| DOREA | NCT07267559 | P4 | recruiting | Learning | 62 | — |
| PAD-DORA | NCT07213349 | P2 | recruiting | Alzheimer Disease (AD) | 240 | — |
All Daridorexant trials (31)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06498128 | Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® | — | recruiting | 785 | Idorsia Pharmaceuticals Ltd. | Nov 2024 | |
| NCT07136415 | CELESTE | Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms | P4 | recruiting | 1,000 | Brigham and Women's Hospital | Feb 2026 |
| NCT07532252 | Daridorexant for Alcohol Use Disorder | P2 | not yet recruiting | 150 | Johns Hopkins University | Jan 2027 | |
| NCT07213349 | PAD-DORA | Daridorexant for Alzheimer Disease Prevention | P2 | recruiting | 240 | Douglas Mental Health University Institute | Oct 2025 |
| NCT05948540 | Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant | P2 | recruiting | 200 | Global Coalition for Adaptive Research | Nov 2023 | |
| NCT05422612 | Department of Defense PTSD Adaptive Platform Trial - Master Protocol | P2 | recruiting | 800 | Global Coalition for Adaptive Research | Nov 2023 | |
| NCT07555743 | Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia | P4 | not yet recruiting | 134 | Institut d'Investigació Biomèdica de Bellvitge | Apr 2026 | |
| NCT06393504 | Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) | — | active not recruiting | 2,095 | Idorsia Pharmaceuticals Ltd. | Nov 2023 | |
| NCT05924425 | DARIDOR-ALZ | Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease | P4 | recruiting | 62 | University Hospital, Montpellier | Mar 2024 |
| NCT07217912 | Daridorexant to Prevent Post-cardiotomy Delirium | P2 | recruiting | 80 | University of Rochester | Oct 2025 | |
| NCT07328594 | Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking | P4 | not yet recruiting | 44 | Legacy Health System | Feb 2026 | |
| NCT07267559 | DOREA | Dual Orexin Antagonism and Emotion and Affective Processing Study | P4 | recruiting | 62 | University of Oxford | Oct 2025 |
| NCT06311864 | Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada | — | completed | 90 | PeriPharm | Jun 2024 | |
| NCT05423717 | Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder | P2 | completed | 166 | Idorsia Pharmaceuticals Ltd. | Sep 2022 | |
| NCT07028697 | A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder | P3 | completed | 164 | Nxera Pharma Korea Co., Ltd. | Dec 2024 | |
| NCT07132086 | Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting | — | completed | 31 | Azienda Ospedaliero, Universitaria Pisana | Oct 2023 | |
| NCT06630390 | Daridorexant to Prevent Delirium After Heart Surgery | P2 | completed | 11 | University of Rochester | Nov 2024 | |
| NCT06010693 | A Study of Daridorexant in Chinese Patients With Insomnia Disorder | P3 | completed | 206 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Aug 2023 | |
| NCT05597020 | A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia | P4 | completed | 60 | Idorsia Pharmaceuticals Ltd. | Feb 2023 | |
| NCT06326723 | Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects | P1 | completed | 32 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Sep 2023 | |
| NCT05877222 | 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 | P1 | completed | 38 | Idorsia Pharmaceuticals Ltd. | Jun 2023 | |
| NCT05632393 | A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women | P1 | completed | 10 | Idorsia Pharmaceuticals Ltd. | Jan 2023 | |
| NCT05702177 | 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 | P1 | completed | 36 | Idorsia Pharmaceuticals Ltd. | Jan 2023 | |
| NCT05458193 | A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep | P1 | completed | 20 | Idorsia Pharmaceuticals Ltd. | Aug 2022 | |
| NCT05480488 | A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects | P1 | completed | 18 | Idorsia Pharmaceuticals Ltd. | Aug 2022 | |
| NCT05480475 | A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects | P1 | completed | 24 | Idorsia Pharmaceuticals Ltd. | Sep 2022 | |
| NCT03679884 | Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep | P3 | completed | 804 | Idorsia Pharmaceuticals Ltd. | Oct 2018 | |
| NCT04250506 | A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects | P1 | completed | 36 | Idorsia Pharmaceuticals Ltd. | Feb 2020 | |
| NCT04390334 | A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. | P1 | completed | 24 | Idorsia Pharmaceuticals Ltd. | May 2020 | |
| NCT03575104 | Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep | P3 | completed | 924 | Idorsia Pharmaceuticals Ltd. | May 2018 | |
| NCT03545191 | Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder | P3 | completed | 930 | Idorsia Pharmaceuticals Ltd. | Jun 2018 |
Daridorexant clinical trials: frequently asked questions
- How many Daridorexant clinical trials are there?
- 31 Daridorexant clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 8 are actively recruiting participants. 19 are marked completed.
- Are Daridorexant clinical trials recruiting in 2026?
- Yes — 8 Daridorexant trials are actively recruiting in 2026, with 24 U.S. sites across 14 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Daridorexant being studied for?
- Daridorexant is being studied for Insomnia Disorder, Healthy, Insomnia, Post Traumatic Stress Disorder, Sleep and 21 more. The trials are grouped by indication on this page.
- What phase is Daridorexant in?
- Daridorexant clinical trials span 6 Phase 4, 5 Phase 3, 7 Phase 2, 9 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Daridorexant clinical trials?
- The lead sponsor across the most Daridorexant trials is Idorsia Pharmaceuticals Ltd., with 13 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Daridorexantas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: