Pitolisant
پیتولیسانت
🧠 Nervous SystemH3 antagonist/inverse agonist
Market / country: 🇺🇸 USA
Wakix (US)
🧮 Dose calculator
Narcolepsy and excessive daytime sleepiness · Regimen source: FDA Wakix · 2.2
- • Week 1: 8.9 mg; week 2: 17.8; week 3: up to 35.6 mg. eGFR <60, moderate hepatic impairment or CYP2D6 poor metabolisers: max 17.8 mg. FDA Wakix · 2.2FDA Wakix · 2.4FDA Wakix · 2.5FDA Wakix · 2.7
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to pitolisant; severe hepatic impairment. FDA Wakix · 4
Warnings
- • QT prolongation — avoid with other QT-prolonging drugs. FDA Wakix · 5
Formulations
- 17.8 mg tablet — tablet 🇺🇸 USA FDA Wakix · 3
- 4.45 mg tablet — tablet 🇺🇸 USA FDA Wakix · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Wakix · 8.1
“Risk Summary Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined 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 Wakix · 8.2
“Risk Summary The transfer of pitolisant into breastmilk is low based on data from a lactation study.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Wakix · 8.4
“The safety and effectiveness of WAKIX have been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients 6 years of age and older with narcolepsy.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Wakix · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Wakix · 8.3
“Contraception WAKIX may reduce the effectiveness of hormonal contraceptives.”
🔗 Reference links
- FDA (approval record)NDA211150
- DailyMed (FDA label)FDA Wakix
- MedlinePlus (NIH)Pitolisant
- WHO ATC/DDDN07XX11
- 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 Wakix · 3FDA Wakix · 2.2FDA Wakix · 2.4FDA Wakix · 2.5FDA Wakix · 2.7FDA Wakix · 4FDA Wakix · 5FDA Wakix · SPL approval / marketing categoryFDA Wakix · 8.1FDA Wakix · 8.2FDA Wakix · 8.4FDA Wakix · 8.5FDA Wakix · 8.3
- 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