Daridorexant
داریدورکسانت
🧠 Nervous SystemDual orexin receptor antagonist
Market / country: 🇺🇸 USA
Quviviq (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Quviviq · 2.1
- • No more than once a night, ≥7 h before awakening. Moderate hepatic impairment max 25 mg; severe not recommended. FDA Quviviq · 2.1FDA Quviviq · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Narcolepsy; hypersensitivity to daridorexant (angioedema). FDA Quviviq · 4
Warnings
- • CNS depression and next-day impairment; sleep paralysis and hypnagogic hallucinations; complex sleep behaviours; compromised respiratory function; worsening depression and suicidal ideation. FDA Quviviq · 5
Formulations
- 25 mg tablet — tablet 🇺🇸 USA FDA Quviviq · 3
- 50 mg tablet — tablet 🇺🇸 USA FDA Quviviq · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Quviviq · 8.1
“Risk Summary There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Quviviq · 8.2
“Risk Summary Daridorexant is present in human breast milk in low amounts.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Quviviq · 8.4
“The safety and effectiveness of QUVIVIQ have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Quviviq · 8.5
“Because QUVIVIQ can increase somnolence and drowsiness, patients, particularly the elderly, are at higher risk of falls [see Warnings and Precautions (5.1) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA214985
- DailyMed (FDA label)FDA Quviviq
- MedlinePlus (NIH)Daridorexant
- WHO ATC/DDDN05CJ03
- Darooyab (Iran)Daridorexant
🇮🇷 Not found in Iran list Darooyab · G-5578/Daridorexant
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Quviviq · 3FDA Quviviq · 2.1FDA Quviviq · 2.3FDA Quviviq · 4FDA Quviviq · 5FDA Quviviq · 8.1FDA Quviviq · 8.2FDA Quviviq · 8.4FDA Quviviq · 8.5FDA Quviviq · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5578/Daridorexant
- Clinical review⚠ Unverified