Suvorexant
سووورکسانت
🧠 Nervous SystemOrexin receptor antagonist
Market / country: 🇺🇸 USA
Belsomra (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Belsomra · 2.1
- • No more than once per night with at least 7 h before waking. Moderate CYP3A inhibitors → 5 mg; strong inhibitors not recommended. FDA Belsomra · 2.1FDA Belsomra · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Narcolepsy. FDA Belsomra · 4
Warnings
- • Next-day impairment (driving); complex sleep behaviours; sleep paralysis and hallucinations. FDA Belsomra · 5
Formulations
- 5 mg tablet — tablet 🇺🇸 USA FDA Belsomra · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Belsomra · 3
- 15 mg tablet — tablet 🇺🇸 USA FDA Belsomra · 3
- 20 mg tablet — tablet 🇺🇸 USA FDA Belsomra · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Belsomra · 8.1
“Risk Summary Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Belsomra · 8.2
“Risk Summary Suvorexant and its metabolite, hydroxy suvorexant, are present in low concentrations in breast milk with a relative infant dose of less than 1% following maternal oral administration (see Data ) .”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Belsomra · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Belsomra · 8.5
“Because BELSOMRA can increase drowsiness, patients, particularly the elderly, are at a 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)NDA204569
- DailyMed (FDA label)FDA Belsomra
- MedlinePlus (NIH)Suvorexant
- WHO ATC/DDDN05CJ01
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
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 Belsomra · 3FDA Belsomra · 2.1FDA Belsomra · 2.4FDA Belsomra · 4FDA Belsomra · 5FDA Belsomra · SPL approval / marketing categoryFDA Belsomra · 8.1FDA Belsomra · 8.2FDA Belsomra · 8.4FDA Belsomra · 8.5
- 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 · search
- Clinical review⚠ Unverified