2 Information about pitolisant hydrochloride

Marketing authorisation indication

2.1 Pitolisant hydrochloride (Ozawade, Bioprojet Pharma) is indicated 'to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP)'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics for pitolisant hydrochloride.


2.3 The list price of pitolisant hydrochloride is £138 for a 30‑pack of 4.5‑mg or 18‑mg tablets (excluding VAT; company submission).

  • National Institute for Health and Care Excellence (NICE)