Quviviq Daridorexant Hydrochloride Tablets

1. Indications and Usage
Insomnia:
Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
2. Dosage and Administration
Recommended Dosage:
Adults: 25 mg or 50 mg orally once nightly.
Administration Instructions:
Take within 30 minutes before going to bed.
Ensure at least 7 hours remain before the planned time of awakening.
Taking with or immediately after a meal may delay the onset of sleep.
Dose Modifications:
Concomitant use with moderate CYP3A4 inhibitors: The maximum recommended dose is 25 mg once nightly.
Moderate hepatic impairment (Child-Pugh class B): The maximum recommended dose is 25 mg once nightly.
Note: Avoid use in patients with severe hepatic impairment (Child-Pugh class C).
3. Mechanism of Action
Dual Orexin Receptor Antagonist (DORA):
Daridorexant is an orexin receptor antagonist.
Physiological Effect:
It binds with high affinity to orexin receptors OX1R and OX2R, blocking the binding of the wake-promoting neuropeptides orexin A and orexin B. By antagonizing orexin receptors, it suppresses the wake drive, thereby facilitating the transition to and maintenance of sleep.
4. Safety and Warnings
Central Nervous System (CNS) Depressant Effects and Daytime Impairment:
Daridorexant can impair daytime wakefulness. Patients should be warned not to drive or engage in other activities requiring complete mental alertness if they feel drowsy the next day.
Complex Sleep Behaviors:
Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported. Discontinue immediately if a patient experiences a complex sleep behavior.
Worsening of Depression and Suicidal Ideation:
Worsening of depression and suicidal thoughts or actions have been reported. Monitor for these symptoms.
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms:
Patients may experience an inability to move or speak for up to several minutes during sleep-wake transitions, or experience vivid and disturbing perceptions.
Respiratory Depression:
Consider the potential for respiratory depression in patients with compromised respiratory function (e.g., COPD, Obstructive Sleep Apnea).
5. Adverse Reactions
Most Common:
Headache, somnolence/fatigue, and dizziness.
6. Drug Interactions
CNS Depressants:
Concomitant use with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) may increase the risk of CNS depression. Avoid use with alcohol.
CYP3A4 Inhibitors:
Strong CYP3A4 inhibitors (e.g., itraconazole): Avoid concomitant use.
Moderate CYP3A4 inhibitors (e.g., diltiazem): Reduce the dose of daridorexant to 25 mg.
CYP3A4 Inducers:
Avoid concomitant use with strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine) as they may decrease the efficacy of daridorexant.
7. Pharmaceutical Information
Chemical Name:
2-(2,5-Dimethylpyrazin-3-yl)-5-methoxy-N-[(2S)-2-methyl-2,3-dihydro-1,4-benzoxazin-4-yl]pyrimidin-4-amine hydrochloride.
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).