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Quviviq Generic Name & Formulations
Legal Class
CIV
General Description
Daridorexant 25mg, 50mg; tabs.
Pharmacological Class
Orexin receptor antagonist.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Quviviq Indications
Indications
Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Quviviq Dosage and Administration
Adult
Take within 30mins of bedtime (with ≥7hrs remaining prior to planned awakening). 25–50mg once per night. Concomitant moderate CYP3A4 inhibitors or moderate hepatic impairment (Child-Pugh score 7–9): max 25mg once per night. Effect may be delayed if taken with or soon after a meal.
Children
Not established.
Quviviq Contraindications
Contraindications
Narcolepsy.
Quviviq Boxed Warnings
Not Applicable
Quviviq Warnings/Precautions
Warnings/Precautions
CNS depression. Daytime impairment (including impaired driving w. 50mg dose). Monitor for somnolence. Discontinue immediately if complex sleep behaviors develop. Compromised respiratory function (eg, severe COPD [FEV1 <40% of predicted], moderate obstructive sleep apnea [OSA] requiring CPAP, or severe OSA). Suicidal ideation or behavior. Depression. Monitor for worsening insomnia or new cognitive/behavioral abnormalities. Reevaluate if unresponsive after 7–10 days of treatment. Drug or alcohol abusers. Severe hepatic impairment: not recommended. Elderly. Pregnancy. Nursing mothers.
Quviviq Pharmacokinetics
See Literature
Quviviq Interactions
Interactions
Avoid alcohol. Potentiates CNS depression with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol); may need to adjust doses. Concomitant strong CYP3A4 inhibitors (eg, itraconazole), other drugs to treat insomnia: not recommended. Concomitant moderate CYP3A4 inhibitors (eg, diltiazem): reduce dose (see Adult). Antagonized by strong or moderate CYP3A4 inducers (eg, rifampin, efavirenz); avoid.
Quviviq Adverse Reactions
Adverse Reactions
Headache, somnolence, fatigue; complex sleep behaviors (eg, sleep-walking, sleep-driving), sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms.
Quviviq Clinical Trials
See Literature
Quviviq Note
Not Applicable
Quviviq Patient Counseling
See Literature
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