Pitolisant is a histamine-3 receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. It is available as tablets for oral use. MedsAcross supplies Pitolisant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy patients 6 years of age and older with narcolepsy
Source: US FDA prescribing information
The mechanism of action of pitolisant in excessive daytime sleepiness (EDS) or cataplexy in patients 6 years and older with narcolepsy is unclear. However, its efficacy could be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors.
Source: US FDA prescribing information
See Full Prescribing Information for complete dosage instructions. Administer orally once daily in the morning upon wakening. Dosage Recommendations: Adults. Week 1 Initiate with a dosage of 8.9 mg once daily Week 2 Increase dosage to 17.8 mg once daily Week 3 May increase to the maximum recommended dosage of 35.6 mg once daily Pediatric Patients (6 years and older). Week 1 Initiate with a dosage of 4.45 mg once daily Week 2 Increase dosage to 8.9 mg once daily Week 3 Increase dosage to 17.8 mg once daily, the maximum recommended dosage for patients weighing <40 kg Week 4 For patients weighing ≥40 kg, may increase to the maximum recommended dosage of 35.6 mg once daily Hepatic impairment: Moderate hepatic impairment (Child-Pugh Class B): Adults: Initial dosage is 8.9 mg once daily.
Source: US FDA prescribing information
WAKIX is contraindicated in patients with: known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with WAKIX. severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate hepatic impairment. Known hypersensitivity to pitolisant or any component of the formulation. Severe hepatic impairment
Source: US FDA prescribing information
QT Interval Prolongation: Increases in QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. Monitor patients with hepatic or renal impairment for increased QTc
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: QT Interval Prolongation Most common adverse reactions (≥5% and at least twice placebo) in adults: insomnia, nausea, and anxiety. Most common adverse reactions (≥5% and greater than placebo) in pediatric patients 6 years and older: headache and insomnia.
Source: US FDA prescribing information
Strong CYP2D6 Inhibitors: Increased exposure of WAKIX, reduce the maximum recommended dose of WAKIX by half. Strong CYP3A4 Inducers: Decreased exposure of WAKIX, consider dosage adjustment of WAKIX. Sensitive CYP3A4 Substrates (including hormonal contraceptives): WAKIX may reduce effectiveness of sensitive CYP3A4 substrates. Use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment
Source: US FDA prescribing information
Store at 20° C to 25° C (68° F to 77° F), excursions permitted between 15° C to 30° C (59° F to 86° F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Pitolisant, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Pitolisant 17.8 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pitolisant 4.45 mg tabletOralGeneric name | — | US FDA | Available on request |
| Wakix 17.8 mg tabletOral | Harmony Biosciences | US FDA | Available on request |
| Wakix 4.45 mg tabletOral | Harmony Biosciences | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 4 presentations of Pitolisant and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Pitolisant, including Wakix.
Yes. The US FDA first approved Pitolisant on 14 August 2019, according to Drugs@FDA.
Yes. Pitolisant has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Pitolisant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Pitolisant is classified under ATC code N07XX11 (Pitolisant).
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