Daridorexant
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Orexin Receptor Antagonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Dosage Recommendations for Patients with Hepatic Impairment The maximum recommended dosage in patients with moderate hepatic impairment (Child-Pugh score 7–9) is 25 mg of QUVIVIQ no more than once per night [see Use in Specific Populations , Clinical Pharmacology ] . QUVIVIQ is not recommended in patients with severe hepatic impairment (Child-Pugh score ≥ 10) [see Use in Specific Populations ] .
Preparation and administration
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 , Clinical Pharmacology ] . 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 , Clinical Pharmacology ] .
Co-administration with Strong or Moderate CYP3A4 Inducers Avoid concomitant use of QUVIVIQ with strong or moderate CYP3A4 inducers [see Drug Interactions ] .
Drug interactions
Check daridorexant against a medication listLabel text (6 paragraphs)
Strong CYP3A4 inhibitors: Avoid concomitant use. ( 2.2 , 7.1 ) Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg. ( 2.2 , 7.1 ) Moderate or Strong CYP3A4 inducers: Avoid concomitant use. ( 7.1 )
7.1 Effects of Other Drugs on QUVIVIQ Table 2 describes clinically significant drug interactions where the concomitant use of other drugs affects QUVIVIQ. Table 2 Effects of Other Drugs on QUVIVIQ Strong or Moderate CYP3A4 Inhibitors Clinical Implications: Concomitant use with a strong or moderate CYP3A4 inhibitor increases exposure to daridorexant [see Clinical Pharmacology (12.3) ] , which may increase the risk of QUVIVIQ adverse reactions. Prevention or Management: The recommended dose of QUVIVIQ is 25 mg when used with a moderate CYP3A4 inhibitor [see Dosage and Administration (2.2) ] .
Concomitant use of QUVIVIQ with a strong inhibitor of CYP3A4 is not recommended [see Dosage and Administration (2.2) ] . Strong and Moderate CYP3A4 Inducers Clinical Implications: Concomitant use with a strong or moderate CYP3A4 inducer decreases exposure to daridorexant [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of QUVIVIQ. Prevention or Management: Concomitant use of QUVIVIQ with a strong or moderate inducer of CYP3A4 is not recommended [see Dosage and Administration (2.2) ] .
Alcohol and Other CNS Depressants Clinical Implications: Concomitant use of alcohol or other CNS depressants with QUVIVIQ may lead to additive impairment of psychomotor performance and risk of CNS depression [see Clinical Pharmacology (12.2) ] . Prevention or Management: Avoid alcohol consumption with QUVIVIQ [see Warnings and Precautions (5.1) ] . Use with caution in patients receiving CNS depressants. Consider dose adjustment of QUVIVIQ and/or the CNS depressant(s) if used concomitantly [see Warnings and Precautions (5.1) ] .
7.2 Effects of QUVIVIQ on Other Drugs Table 3 describes clinically significant drug interactions where the concomitant use of QUVIVIQ affects other drugs. Table 3 Effects of QUVIVIQ on Other Drugs CYP3A4 Substrates Clinical Implications: Concomitant use of QUVIVIQ with CYP3A4 substrates increases the exposure to CYP3A4 substrate [see Clinical Pharmacology (12.3) ] . Prevention or Management: Use with caution in patients receiving CYP3A4 substrates with narrow therapeutic index. P-gp Substrates Clinical Implications: Concomitant use of QUVIVIQ with P-gp substrates increases the exposure to P-gp substrate [see Clinical Pharmacology (12.3) ] .
Prevention or Management: Use with caution in patients receiving P-gp substrates with a narrow therapeutic index.
Contraindications
4 CONTRAINDICATIONS QUVIVIQ is contraindicated: in patients with narcolepsy. in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ. Angioedema with pharyngeal involvement has been reported [see Adverse Reactions (6.2) ] . Narcolepsy. ( 4 ) Known hypersensitivity to daridorexant or other components of QUVIVIQ. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Daridorexant is an orexin receptor antagonist currently used in the treatment of insomnia in adults. Daridorexant is associated with rare instances of elevations in serum aminotransferase levels during therapy but has not been implicated in cases of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
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. Data Animal Data Daridorexant was administered orally to pregnant rats during the period of organogenesis at doses of 30, 100, and 300 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 50 mg, respectively, based on AUC. Daridorexant did not cause any maternal or embryofetal toxicities or fetal malformation at doses up to 300 mg/kg/day. The NOAEL for maternal and fetal toxicity is 300 mg/kg/day, which is approximately 8 times the MRHD of 50 mg, based on AUC.
Daridorexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 60, and 120 mg/kg/day, which are approximately 3, 4, and 10 times the MRHD of 50 mg, respectively, based on AUC. Daridorexant did not cause any fetal toxicity or malformation at doses up to 120 mg/kg/day. Daridorexant caused maternal toxicities of decreased weight gain and food consumption at the dose of 120 mg/kg/day. The NOAELs for maternal and fetal toxicity are 60 and 120 mg/kg/day, respectively, which are approximately 4 and 10 times the MRHD of 50 mg, respectively, based on AUC.
Daridorexant was administered orally to pregnant rats during gestation and lactation at doses of 50, 100, and 300 mg/kg/day, which are approximately 1, 3, and 9 times the MRHD of 50 mg,…
Breastfeeding (LactMed)
Amounts of daridorexant in milk are very low. If daridorexant is required by the mother, it is not a reason to discontinue breastfeeding. Until more data in breastfed infants are available, monitor the infant for sedation, poor feeding and poor weight gain.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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