Is Pitolisant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Pitolisant, including Ozawade (4.5 mg, Film-coated tablet, SAR 993.35).

Is Pitolisant approved by the US FDA?

Drugs@FDA lists 4 application product lines for Pitolisant, including WAKIX (Prescription); PITOLISANT HYDROCHLORIDE (Prescription); PITOLISANT HYDROCHLORIDE (Prescription); PITOLISANT HYDROCHLORIDE (Prescription).

Is Pitolisant authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Pitolisant: Wakix, Ozawade.

Are there safety signals or safety updates for Pitolisant?

US FDA: 1 entry (latest 2026-02-13).

Active substance

Pitolisant

SFDA 1
US FDA 4
EMA 2
Health Canada 2
NHS prices 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ozawade	4.5 mg	Film-coated tablet · Oral use	30 Bottle	SAR 993.35	NCE · Prescription	Acino AG	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
WAKIX	EQ 4.45MG BASE; EQ 17.8MG BASE	tablet · oral	HARMONY	Prescription	14 Aug 2019
PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE; EQ 17.8MG BASE	tablet · oral	NOVITIUM PHARMA	Prescription	21 Jul 2026
PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE; EQ 17.8MG BASE	tablet · oral	LUPIN	Prescription	14 Aug 2026
PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE; EQ 17.8MG BASE	tablet · oral	MSN	Prescription	14 Aug 2026

EMA European Union — centrally authorised medicines

Wakix Bioprojet Pharma · Authorised · authorised 31 Mar 2016 · ATC N07XX11

Therapeutic indication (EMA)

Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).

Ozawade Bioprojet Pharma · Authorised · authorised 1 Sep 2021 · ATC N07XX11

Therapeutic indication (EMA)

Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
WAKIX	02516241	5 MG	TABLET · ORAL	KNIGHT THERAPEUTICS INC.
WAKIX	02516268	20 MG	TABLET · ORAL	KNIGHT THERAPEUTICS INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Pitolisant 18mg tablets	£310.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Pitolisant 4.5mg tablets	£310.00	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 13 Feb 2026 WAKIX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for pitolisant →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.