pitolisant
Ozawade, Wakix · ATC code N07XX11
- Key facts
- Active substance
- pitolisant
- ATC code
- N07XX11
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ozawade 4.5 mg film-coated tablets / Ozawade 18 mg film-coated tablets · Wakix 4.5 mg film-coated tablets / Wakix 18 mg film-coated tablets
- Marketing authorisation holder
- Bioprojet Pharma
- Information as of
- 2026-10-27
Key facts
Pitolisant is a histamine H3 receptor antagonist/inverse agonist. As Wakix it is used for narcolepsy; as Ozawade for excessive daytime sleepiness in obstructive sleep apnoea.
What it is used for
- Wakix: narcolepsy with or without cataplexy in adults, adolescents and children from 6 years of age
- Ozawade: excessive daytime sleepiness in adults with obstructive sleep apnoea not satisfactorily treated by, or intolerant of, primary therapy such as CPAP
- Ozawade is not a therapy for the underlying airway obstruction
Dosing
- Total daily dose once in the morning during breakfast; lowest effective dose
- Wakix, adults: week 1 9 mg/day, week 2 18 mg (or 4.5 mg), from week 3 up to 36 mg/day; maximum 36 mg/day
- Wakix, children: start 4.5 mg/day, stepwise titration; maximum 36 mg/day (18 mg/day below 40 kg)
- Ozawade: week 1 4.5 mg/day, week 2 9 mg, from week 3 18 mg/day; maximum 18 mg/day
- Renal impairment: maximum 18 mg daily; moderate hepatic impairment: increase after two weeks up to 18 mg
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Severe hepatic impairment (Child-Pugh C)
- Breastfeeding
Important warnings
- Caution with a psychiatric history; suicidal ideation reported
- Caution in acid-related gastric disorders or with corticosteroids/NSAIDs
- Caution in severe obesity or anorexia; re-evaluate after significant weight change
- QTc prolongation at supra-therapeutic doses; caution in cardiac disease
- Caution in moderate hepatic or renal impairment
Side effects
- Wakix: insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%)
- Ozawade: headache 9.5%, insomnia 8.0%, anxiety 2.7%, nausea 2.3%
- Dizziness, depression, tremor, vomiting, dyspepsia
- Most serious: abnormal weight decrease and spontaneous abortion (0.09% each)
Interactions
- Tri- or tetracyclic antidepressants (e.g., imipramine, clomipramine, mirtazapine) and brain-penetrant H1 antihistamines may impair efficacy
- QT-prolonging substances only with careful monitoring
- May reduce the effectiveness of hormonal contraceptives; enzyme inducers are covered in the full text
Pregnancy and breastfeeding
- Effective non-hormonal contraception until at least 21 days after stopping; teratogenic in animals
- Contraindicated during breastfeeding
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Ozawade, Wakix
- Liechtenstein
- Ozawade, Wakix
- Norway
- Ozawade, Wakix
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Ozawade – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ozawade-epar-product-information_en.pdf
- European Medicines Agency. Wakix – EPAR, Product Information (Detailed information on this medicinal product is available ). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/wakix-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.