QUVIQIU
Generic Name/API: daridorexant
Manufacturer: Idorsia Pharmaceuticals
Dosage Forms & Strength & Pack Size:
Tablets: 25 mg, 50 mg.
Storage:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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.
————————WARNINGS AND PRECAUTIONS———————–
• 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)
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