36 completed, 7 not yet recruiting, 7 recruiting, 1 active not recruiting. 24 Phase 1, 8 Phase 2, 8 Phase 4, 6 Phase 3, 1 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Daridorexant for Alcohol Use Disorder Daridorexant 50 mg, Placebo - Alcohol Use Disorder | Phase 2 | Not yet recruiting | Johns Hopkins University | 150 | 2027-01-01 | 2026-04-20 |
| A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day Daridorexant, Placebo - Insomia Disorder | Phase 3 | Recruiting | Idorsia Pharmaceuticals Ltd. | 344 | 2026-10-28 | 2026-11-05 |
| A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia Daridorexant 50 mg - Insomnia | Not yet recruiting | Shanghai Mental Health Center | 500 | 2026-10-01 | 2026-09-29 | |
| Study on the Management of COMISA Daridorexant 50 mg, Continuous Positive Air Pressure (CPAP) - Obstructive Sleep Apnea (OSA), Insomnia | Not applicable | Recruiting | University Hospital, Grenoble | 150 | 2026-09-30 | 2026-10-05 |
| Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis Daridorexant, Placebo - Liver Cirrhosis, Sleep Disturbance | Phase 4 | Not yet recruiting | Wang Fengmei | 180 | 2026-09-01 | 2026-10-16 |
| Daridorexant for People With Insomnia and Alcohol Use Disorder Study Daridorexant, Placebo, Brief Counseling - Alcohol Use Disorder, Insomnia | Phase 2 | Not yet recruiting | Sterling McPherson | 205 | 2026-09-01 | 2026-07-14 |
| Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP） Daridorexant - Insomnia Disorders | Phase 4 | Not yet recruiting | Xuanwu Hospital, Beijing | 156 | 2026-08-01 | 2026-07-29 |
| Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia Daridorexant 50 mg, Placebo - Insomnia, Major Depressive Disorder | Phase 4 | Not yet recruiting | Institut d'Investigació Biomèdica de Bellvitge | 134 | 2026-04-01 | 2026-04-29 |
| Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms Cognitive behavioral therapy for insomnia (CBT-i), Trazodone, Daridorexant - Menopausal Women, Insomnia | Phase 4 | Recruiting | Brigham and Women's Hospital | 1000 | 2026-02-13 | 2026-06-08 |
| Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking Daridorexant 50 mg, Placebo - Smoking, Nicotine | Phase 4 | Not yet recruiting | Legacy Health System | 44 | 2026-02-10 | 2026-01-09 |
| Daridorexant for Alzheimer Disease Prevention Daridorexant 50 mg, Placebo - Alzheimer Disease (AD) | Phase 2 | Recruiting | Douglas Mental Health University Institute | 240 | 2025-10-14 | 2025-12-19 |
| Daridorexant to Prevent Post-cardiotomy Delirium Daridorexant 50 mg, Placebo - Postoperative Cognitive Decline, Postoperative Delirium | Phase 2 | Recruiting | University of Rochester | 80 | 2025-10-14 | 2026-01-07 |
| Dual Orexin Antagonism and Emotion and Affective Processing Study Daridorexant 50 mg, Placebo - Learning, Cognitive Functioning | Phase 4 | Recruiting | University of Oxford | 62 | 2025-10-01 | 2026-03-19 |
| A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Nxera Pharma Korea Co., Ltd. | 164 | 2024-12-04 | 2026-01-21 |
| Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ® Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication - Insomnia | Terminated | Idorsia Pharmaceuticals Ltd. | 3 | 2024-11-21 | 2026-10-29 | |
| Daridorexant to Prevent Delirium After Heart Surgery Daridorexant 50 mg, Placebo - POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINE | Phase 2 | Completed | University of Rochester | 11 | 2024-11-11 | 2025-07-11 |
| Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada Daridorexant 50 mg - Insomnia | Completed | PeriPharm | 90 | 2024-06-20 | 2026-05-27 | |
| Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease Daridorexant 50 mg, Placebo, Polysomnography - Alzheimer Disease, Insomnia Disorder | Phase 4 | Recruiting | University Hospital, Montpellier | 62 | 2024-03-13 | 2026-06-25 |
| Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication - Insomnia Disorder | Active not recruiting | Idorsia Pharmaceuticals Ltd. | 2095 | 2023-11-30 | 2025-08-19 | |
| Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting Daridorexant 50 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical setting - Insomnia Chronic | Completed | Azienda Ospedaliero, Universitaria Pisana | 31 | 2023-10-01 | 2025-08-20 |
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Sleep Initiation and Maintenance Disorders (22) · Alzheimer Disease (4) · Cognitive Dysfunction (3) · Alcoholism (2) · Delirium (2) · Emergence Delirium (2) · Postoperative Cognitive Complications (2) · Sleep Apnea, Obstructive (2) · Behavior, Addictive (1) · Depressive Disorder, Major (1) · Hepatic Encephalopathy (1) · Liver Cirrhosis (1) · Nocturia (1) · Parasomnias (1) · Pick Disease of the Brain (1)
Idorsia Pharmaceuticals Ltd. (33) · Jiangsu Simcere Pharmaceutical Co., Ltd. (2) · University of Rochester (2) · Azienda Ospedaliero, Universitaria Pisana (1) · Brigham and Women's Hospital (1) · Douglas Mental Health University Institute (1) · Institut d'Investigació Biomèdica de Bellvitge (1) · Johns Hopkins University (1) · Legacy Health System (1) · Nxera Pharma Korea Co., Ltd. (1) · PeriPharm (1) · Shanghai Mental Health Center (1) · Sterling McPherson (1) · University Hospital, Grenoble (1) · University Hospital, Montpellier (1)
United States (18) · Germany (16) · Canada (6) · Netherlands (6) · Spain (6) · China (5) · Czechia (5) · France (4) · Switzerland (4) · Bulgaria (3) · Hungary (3) · Italy (3) · South Korea (3) · Sweden (3) · Belgium (2)
Clemens Muehlan (2) · Marie-Laure Boof, PhD (2) · Catherine J Harmer, DPhil (1) · Enrica Bonanni, MD, PhD (1) · Jean Lachaine, PhD (1) · Jennifer Ellis (1) · Juan Li (1)
PMID 37526060, PMID 35065036, PMID 36054921, PMID 37477771, PMID 37796657, PMID 38644625, PMID 41217192, PMID 31642731, PMID 31953863, PMID 32341187, PMID 33205362, PMID 33305817, PMID 34002356, PMID 34331678, PMID 34480579, PMID 35306405, PMID 36098936, PMID 36484969, PMID 37286927, PMID 37858005, PMID 38302765, PMID 38472696, PMID 39641404, PMID 40288253, PMID 40557879, PMID 40660750, PMID 41506007, PMID 41942161, PMID 42171662, PMID 42836930
2018 (2), 2019 (2), 2014 (1), 2016 (1)