Daridorexant

The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness.

• QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ] . QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.ICD-10: G47.00

• QUVIVIQ is contraindicated: in patients with narcolepsy. in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ.contraindicated

The recommended dosage is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening. ( 2.1 ) Time to sleep onset may be delayed if taken with or soon after a meal. ( 2.1 ) Hepatic Impairment: ( 2.3 ) Moderate hepatic impairment: Maximum recommended dosage is 25 mg no more than once per night. Severe hepatic impairment: Not recommended. 2.1 Recommended Dosage The recommended dosage range is 25 mg to 50 mg of QUVIVIQ taken orally no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to sleep onset may be delayed if taken with or soon after a meal [see Clinical Pharmacology (12.3) ] . 2.2 Dosage Recommendations for Concomitant Use with CYP3A4 Inhibitors or CYP3A4 Inducers Co-administration with Strong CYP3A4 Inhibitors Avoid concomitant use of QUVIVIQ with strong inhibitors of CYP3A4 [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . Co-administration with Moderate CYP3A4 Inhibitors The recommended dosage of QUVIVIQ is 25 mg no more than once per night when used with moderate inhibitors of CYP3A4 [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . Co-administration with Strong or Moderate CYP3A4 Inducers Avoid concomitant use of QUVIVIQ with strong or moderate CYP3A4 inducers [see Drug Interactions (7.1) ] .

CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases when used with other central nervous system (CNS) depressants. For patients taking QUVIVIQ, caution against next-day driving and other activities requiring complete mental alertness. ( 5.1 ) Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. ( 5.2 ) Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of QUVIVIQ. ( 5.3 ) Complex Sleep Behaviors: Behaviors including sleepwalking, sleep driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if complex sleep behavior occurs. ( 5.4 ) Compromised Respiratory Function: Effect on respiratory function should be considered. ( 5.5 , 8.7 ) Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days. ( 5.6 ) 5.1 CNS-Depressant Effects and Daytime Impairment QUVIVIQ is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. CNS-depressant effects may persist in some patients for up to several days after discontinuing QUVIVIQ. Prescribers should advise patients about the potential for next-day somnolence. Driving ability was impaired in some subjects taking QUVIVIQ 50 mg [see Clinical Studies (14.2) ] .

The following are discussed in detail in other sections of the labeling: CNS-Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions (5.3) ] Complex Sleep Behaviors [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5) ] The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Idorsia Pharmaceuticals Ltd at toll-free phone 1-833-400-9611 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The safety of QUVIVIQ was evaluated in three placebo-controlled clinical studies (two 3-month studies of identical design [Study 1 and Study 2], and a 9-month extension study [Study 3]). Study 1 evaluated 50 mg and 25 mg doses of QUVIVIQ, while Study 2 evaluated a 25 mg dose and a 10 mg dose of QUVIVIQ. The 10 mg dose is not an approved dose.

8.1 Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and healthcare providers are encouraged to call Idorsia Pharmaceuticals Ltd at 1-833-400-9611. Risk Summary There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of daridorexant to pregnant rats and rabbits during the period of organogenesis did not cause fetal toxicity or malformation at doses up to 8 and 10 times the maximum recommended human dose (MRHD) of 50 mg, respectively, based on AUC. Oral administration of daridorexant to pregnant and lactating rats did not cause any maternal or developmental toxicity at doses up to 9 times the MRHD, based on AUC (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Daridorexant plasma exposure is dose proportional from 25 mg to 50 mg. The daridorexant pharmacokinetic profile is similar following multiple-dose and single-dose administration with no accumulation.

There is limited clinical experience with QUVIVIQ overdose. In clinical pharmacology studies, healthy subjects were administered single doses of up to 200 mg (4 times the maximum recommended dose) of QUVIVIQ. The following adverse reactions were observed: somnolence, muscle weakness, cataplexy-like symptoms, sleep paralysis, disturbance in attention, fatigue, headache, and constipation. There is no specific antidote to an overdosage of QUVIVIQ. In the event of an overdose, general symptomatic and supportive medical care, along with immediate gastric lavage where appropriate, should be provided and patients should be carefully monitored. Dialysis is unlikely to be effective as daridorexant is highly protein bound. Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

• Jan 7, 2022NDANDA214985Idorsia

1. 1Drug Ineffective46019%
2. 2Insomnia29312%
3. 3Nightmare27311%
4. 4Somnolence1687.0%
5. 5Fatigue1586.6%
6. 6Headache1586.6%
7. 7Product Availability Issue1476.1%
8. 8Abnormal Dreams1285.3%
9. 9Inappropriate Schedule Of Product Administration1205.0%
10. 10Feeling Abnormal1195.0%
11. 11Wrong Technique In Product Usage Process883.7%
12. 12Nausea813.4%
13. 13Dizziness783.3%
14. 14Suicidal Ideation783.3%
15. 15Therapeutic Product Effect Incomplete753.1%

The 10 most recently updated of 48 ClinicalTrials.gov registrations naming Daridorexant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
  Recruiting · Phase 4 · Interventional · 1,000 enrolled · Brigham and Women's Hospital
  NCT07136415updated 2026-06-08
• Department of Defense PTSD Adaptive Platform Trial - Master Protocol
  Recruiting · Phase 2 · Interventional · 800 enrolled · Global Coalition for Adaptive Research
  NCT05422612updated 2026-06-05
• Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada
  Completed · Observational · 90 enrolled · PeriPharm
  NCT06311864updated 2026-05-27
• Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant
  Recruiting · Phase 2 · Interventional · 200 enrolled · Global Coalition for Adaptive Research
  NCT05948540updated 2026-05-27
• Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
  Not yet recruiting · Phase 4 · Interventional · 134 enrolled · Institut d'Investigació Biomèdica de Bellvitge
  NCT07555743updated 2026-04-29
• Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
  Recruiting · Phase 4 · Interventional · 62 enrolled · University Hospital, Montpellier
  NCT05924425updated 2026-04-23
• Daridorexant for Alcohol Use Disorder
  Not yet recruiting · Phase 2 · Interventional · 150 enrolled · Johns Hopkins University
  NCT07532252updated 2026-04-20
• Dual Orexin Antagonism and Emotion and Affective Processing Study
  Recruiting · Phase 4 · Interventional · 62 enrolled · University of Oxford
  NCT07267559updated 2026-03-19
• Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
  Completed · Phase 2 · Interventional · 166 enrolled · Idorsia Pharmaceuticals Ltd.
  NCT05423717updated 2026-03-06
• A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
  Completed · Phase 3 · Interventional · 164 enrolled · Nxera Pharma Korea Co., Ltd.
  NCT07028697updated 2026-01-21

Frequently asked questions

How does Daridorexant work?

The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness.

What is Daridorexant used for?

According to FDA labeling, Daridorexant carries indications including: QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ] . QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Daridorexant?

Daridorexant is classified as Orexin receptor antagonists, Orexin Receptor Antagonist, Orexin Receptor Antagonists.

What are the brand names for Daridorexant?

Daridorexant is marketed under brand names including Quviviq.

What are the contraindications for Daridorexant?

Daridorexant labeling lists contraindications including: QUVIVIQ is contraindicated: in patients with narcolepsy. in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ.. Always consult the full prescribing information and a clinician.