About this data
Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.
Daridorexant
- Company
- Wang Fengmei
- Mechanism
- Mechanism not yet reported
- Route
- Route not yet reported
- Recruiting trials
- 6 recruiting
Efficacy results: Not yet reported
6 recruiting studies currently listed on ClinicalTrials.gov.
Data source: ClinicalTrials.gov · trial data as of Sep 22, 2026
Find a Clinical Trial Near Me
See recruiting studies for Daridorexant and check eligibility with the study team.
Trial details
-
Recruiting NCT NCT05924425
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
Not yet reported University Hospital, Montpellier 62 participants Est. completion 2028-03-13 1 site Stand-aloneOther conditions: Alzheimer Disease, Insomnia Disorder, SleepView official trial listing → -
Recruiting NCT NCT06498128
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Idorsia Pharmaceuticals Ltd. 785 participants Est. completion 2033-03 7 sitesOther conditions: InsomniaView official trial listing → -
Recruiting NCT NCT07136415
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Not yet reported Brigham and Women's Hospital 1000 participants Est. completion 2031-02 5 sitesOther conditions: Menopausal Women, InsomniaView official trial listing → -
Recruiting NCT NCT07213349
Daridorexant for Alzheimer Disease Prevention
Not yet reported Douglas Mental Health University Institute 240 participants Est. completion 2029-12 1 site Stand-aloneOther conditions: Alzheimer Disease (AD)View official trial listing → -
Recruiting NCT NCT07217912
Daridorexant to Prevent Post-cardiotomy Delirium
Not yet reported University of Rochester 80 participants Est. completion 2027-11-01 1 site Stand-aloneOther conditions: Postoperative Cognitive Decline, Postoperative DeliriumView official trial listing → -
Recruiting NCT NCT07267559
Dual Orexin Antagonism and Emotion and Affective Processing Study
Not yet reported University of Oxford 62 participants Est. completion 2026-10-01 1 site Stand-aloneOther conditions: Learning, Cognitive Functioning, Emotional ProcessingView official trial listing → -
Completed NCT NCT02526888
Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 14 participants Est. completion 2015-11-01 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT02571855
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 85 participants Est. completion 2016-02-01 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT02839200
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Not yet reported Idorsia Pharmaceuticals Ltd. 360 participants Est. completion 2017-06-20 35 sitesOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT02841709
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Not yet reported Idorsia Pharmaceuticals Ltd. 58 participants Est. completion 2017-06-29 10 sitesOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT02919319
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 40 participants Est. completion 2015-05-01 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03017495
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
Not yet reported Idorsia Pharmaceuticals Ltd. 20 participants Est. completion 2017-02-01 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03101189
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 40 participants Est. completion 2017-04-26 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03339752
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin
Not yet reported Idorsia Pharmaceuticals Ltd. 20 participants Est. completion 2017-12-02 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03545191
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Not yet reported Idorsia Pharmaceuticals Ltd. 930 participants Est. completion 2020-02-25 81 sites Stand-aloneOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT03575104
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Not yet reported Idorsia Pharmaceuticals Ltd. 924 participants Est. completion 2020-05-14 86 sites Stand-aloneOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT03609775
A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 22 participants Est. completion 2018-10-09 1 siteOther conditions: HealthyView official trial listing → -
Completed NCT NCT03646864
A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease
Not yet reported Idorsia Pharmaceuticals Ltd. 28 participants Est. completion 2019-09-19 5 sitesOther conditions: Chronic Obstructive Pulmonary DiseaseView official trial listing → -
Completed NCT NCT03657355
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
Not yet reported Idorsia Pharmaceuticals Ltd. 63 participants Est. completion 2019-08-08 2 sitesOther conditions: Healthy Recreational Drug UsersView official trial listing → -
Completed NCT NCT03679884
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Not yet reported Idorsia Pharmaceuticals Ltd. 804 participants Est. completion 2021-02-22 106 sites Stand-aloneOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT03713242
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
Not yet reported Idorsia Pharmaceuticals Ltd. 32 participants Est. completion 2020-02-27 1 siteOther conditions: Hepatic ImpairmentView official trial listing → -
Completed NCT NCT03765294
A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea
Not yet reported Idorsia Pharmaceuticals Ltd. 28 participants Est. completion 2019-11-05 1 siteObstructive sleep apneaView official trial listing → -
Completed NCT NCT03799978
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 20 participants Est. completion 2019-03-18 1 siteOther conditions: HealthyView official trial listing → -
Completed NCT NCT03892902
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 56 participants Est. completion 2019-10-10 1 siteOther conditions: HealthyView official trial listing → -
Completed NCT NCT03907215
A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 24 participants Est. completion 2019-06-26 1 siteOther conditions: HealthyView official trial listing → -
Completed NCT NCT04024332
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 16 participants Est. completion 2020-08-14 1 siteOther conditions: Renal Insufficiency, HealthyView official trial listing → -
Completed NCT NCT04250506
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
Not yet reported Idorsia Pharmaceuticals Ltd. 36 participants Est. completion 2020-07-22 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Completed NCT 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.
Not yet reported Idorsia Pharmaceuticals Ltd. 24 participants Est. completion 2020-06-26 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Suspended NCT NCT05422612
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
Not yet reported Global Coalition for Adaptive Research 800 participants Est. completion 2029-07 9 sites Stand-aloneOther conditions: Post Traumatic Stress DisorderView official trial listing → -
Completed NCT NCT05423717
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
Not yet reported Idorsia Pharmaceuticals Ltd. 166 participants Est. completion 2026-02-05 35 sites Stand-aloneOther conditions: InsomniaView official trial listing → -
Completed NCT NCT05458193
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
Not yet reported Idorsia Pharmaceuticals Ltd. 20 participants Est. completion 2023-02-28 1 site Stand-aloneObstructive sleep apneaView official trial listing → -
Completed NCT 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
Not yet reported Idorsia Pharmaceuticals Ltd. 24 participants Est. completion 2022-09-17 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Completed NCT 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
Not yet reported Idorsia Pharmaceuticals Ltd. 18 participants Est. completion 2022-10-06 1 siteOther conditions: HealthyView official trial listing → -
Completed NCT NCT05597020
A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
Not yet reported Idorsia Pharmaceuticals Ltd. 60 participants Est. completion 2024-04-18 16 sites Stand-aloneOther conditions: Insomnia Disorder, NocturiaView official trial listing → -
Completed NCT NCT05632393
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
Not yet reported Idorsia Pharmaceuticals Ltd. 10 participants Est. completion 2023-04-30 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Completed NCT 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
Not yet reported Idorsia Pharmaceuticals Ltd. 36 participants Est. completion 2023-04-25 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Completed NCT 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
Not yet reported Idorsia Pharmaceuticals Ltd. 38 participants Est. completion 2023-08-04 1 site Stand-aloneOther conditions: HealthyView official trial listing → -
Suspended NCT NCT05948540
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
Not yet reported Global Coalition for Adaptive Research 200 participants Est. completion 2029-07 9 sites Stand-aloneOther conditions: Post Traumatic Stress DisorderView official trial listing → -
Completed NCT NCT06010693
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
Not yet reported Jiangsu Simcere Pharmaceutical Co., Ltd. 206 participants Est. completion 2024-05-10 33 sites Stand-aloneOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT06311864
Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada
PeriPharm 90 participants Est. completion 2026-05-19 1 siteOther conditions: InsomniaView official trial listing → -
Completed NCT NCT06326723
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
Not yet reported Jiangsu Simcere Pharmaceutical Co., Ltd. 32 participants Est. completion 2024-02-05 1 site Stand-aloneOther conditions: Healthy VolunteerView official trial listing → -
Active, not recruiting NCT NCT06393504
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Idorsia Pharmaceuticals Ltd. 2095 participants Est. completion 2028-04 1 siteOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT06630390
Daridorexant to Prevent Delirium After Heart Surgery
Not yet reported University of Rochester 11 participants Est. completion 2025-02-16 1 site Stand-aloneOther conditions: POSTOPERATIVE DELIRIUM, POSTOPERATIVE COGNITIVE DECLINEView official trial listing → -
Completed NCT NCT07028697
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
Not yet reported Nxera Pharma Korea Co., Ltd. 164 participants Est. completion 2025-10-21 17 sites Stand-aloneOther conditions: Insomnia DisorderView official trial listing → -
Completed NCT NCT07132086
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
Azienda Ospedaliero, Universitaria Pisana 31 participants Est. completion 2025-06-30 1 siteOther conditions: Insomnia ChronicView official trial listing → -
Not yet recruiting NCT NCT07328594
Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
Not yet reported Legacy Health System 44 participants Est. completion 2027-09-30 1 siteSubstance use disorder Other conditions: Smoking, Nicotine, Tobacco, Addiction, Insomnia, SleepView official trial listing → -
Not yet recruiting NCT NCT07532252
Daridorexant for Alcohol Use Disorder
Not yet reported Johns Hopkins University 150 participants Est. completion 2031-02-01 Stand-aloneAlcohol use disorderView official trial listing → -
Not yet recruiting NCT NCT07555743
Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
Not yet reported Institut d'Investigació Biomèdica de Bellvitge 134 participants Est. completion 2028-10 1 site Stand-aloneOther conditions: Insomnia, Major Depressive DisorderView official trial listing → -
Not yet recruiting NCT NCT07701928
Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Not yet reported Sterling McPherson 205 participants Est. completion 2031-12 1 site Stand-aloneAlcohol use disorder Other conditions: InsomniaView official trial listing → -
Not yet recruiting NCT NCT07733414
Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients(EASY-TIP)
Not yet reported Xuanwu Hospital, Beijing 156 participants Est. completion 2030-12-01 1 site Stand-aloneOther conditions: Insomnia DisordersView official trial listing → -
Not yet recruiting NCT NCT07743931
Study on the Management of COMISA
Not yet reported University Hospital, Grenoble 150 participants Est. completion 2029-02 4 sitesObstructive sleep apnea Other conditions: Insomnia, COMISAView official trial listing → -
Not yet recruiting NCT NCT07830303
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Not yet reported Wang Fengmei 180 participants Est. completion 2029-02 3 sites Stand-aloneOther conditions: Liver Cirrhosis, Sleep Disturbance, Hepatic EncephalopathyView official trial listing →
Efficacy history
Not yet reported.
Safety
Not yet reported.
Sources
Also known as: Daridorexant, QUVIVIQ
Related On The Pen coverage
No related coverage yet.
This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.
