Lemborexant
لمبورکسانت
🧠 Nervous SystemDual orexin receptor antagonist
Market / country: 🇺🇸 USA
Dayvigo (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Dayvigo · 2.1
- • No more than once a night, ≥7 h before awakening. Moderate/strong CYP3A inhibitors or inducers: avoid; weak inhibitors: max 5 mg. Moderate hepatic impairment max 5 mg; severe not recommended. FDA Dayvigo · 2.1FDA Dayvigo · 2.2FDA Dayvigo · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Narcolepsy. FDA Dayvigo · 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 Dayvigo · 5
Formulations
- 5 mg tablet — tablet 🇺🇸 USA FDA Dayvigo · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Dayvigo · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Dayvigo · 8.1
“Risk Summary There are no available data on DAYVIGO use in pregnant women to evaluate for drug-associated risks 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 Dayvigo · 8.2
“Risk Summary Available data from a lactation study in 8 women indicates that lemborexant is transferred into the breastmilk of nursing mothers, and the results have established a mean daily infant dose of 0.0029 mg/kg/day and a relative infant dose of less than 2% of the maternal dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Dayvigo · 8.4
“The safety and effectiveness of DAYVIGO 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 Dayvigo · 8.5
“Because DAYVIGO can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Warning s 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)NDA212028
- DailyMed (FDA label)FDA Dayvigo
- MedlinePlus (NIH)Lemborexant
- WHO ATC/DDDN05CJ02
- 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 Dayvigo · 3FDA Dayvigo · 2.1FDA Dayvigo · 2.2FDA Dayvigo · 2.3FDA Dayvigo · 4FDA Dayvigo · 5FDA Dayvigo · SPL approval / marketing categoryFDA Dayvigo · 8.1FDA Dayvigo · 8.2FDA Dayvigo · 8.4FDA Dayvigo · 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