Sleep-wake disorders:

Indications for: QUVIVIQ

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Adult Dosage:

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 Dosage:

Not established.

QUVIVIQ Contraindications:

Narcolepsy.

QUVIVIQ 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 Classification:

Orexin receptor antagonist.

QUVIVIQ 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.

Adverse Reactions:

Headache, somnolence, fatigue; complex sleep behaviors (eg, sleep-walking, sleep-driving), sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms.

Generic Drug Availability:

NO

How Supplied:

Tabs—30