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NERVOUS SYSTEM › PSYCHOLEPTICS › HYPNOTICS AND SEDATIVES › Orexin receptor antagonists
daridorexant
N05CJ03
Forms & Strengths
- Oral tablets: 25 mg
- Oral tablets: 50 mg
Adult Dosing
- Insomnia: 25 mg to 50 mg orally once nightly, taken within 30 minutes before going to bed
- Maximum recommended dose: 50 mg once daily
- Allow at least 7 hours remaining before planned awakening
Pediatric Dosing
- Safety and efficacy in pediatric patients (< 18 years) have not been established
Indications
- Treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance
Mechanism of Action
- Dual orexin receptor antagonist (DORA)
- Blocks the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R
- Suppresses the wake drive to facilitate sleep
Contraindications
- Narcolepsy
- Hypersensitivity to daridorexant or any excipients
Adverse Reactions
- Headache
- Somnolence or fatigue
- Dizziness
- Nasopharyngitis
- Sleep paralysis
- Hypnagogic/hypnopompic hallucinations
- Complex sleep behaviors (e.g., sleep-walking, sleep-driving)
Drug Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): significantly increase daridorexant exposure; maximum recommended dose is 25 mg
- Strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's wort): significantly decrease daridorexant efficacy; coadministration is not recommended
- CNS depressants (e.g., alcohol, opioids, sedatives): additive psychomotor impairment and CNS depression
- Moderate CYP3A4 inhibitors: limit dose or use with caution based on clinical response
Curated Content: Needs Vetting Before Put to Clinical Use