Advice

in the absence of a submission from the holder of the marketing authorisation:

pitolisant (Wakix®) is not recommended for use within NHSScotland.

Indication under review: 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).

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.

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Medicine details

Medicine name:
pitolisant (Wakix)
SMC ID:
SMC2662
Indication:

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).

Pharmaceutical company
Bioprojet UK Limited
BNF chapter
Central nervous system
Submission type
Non submission
Status
Not recommended
Date advice published
11 March 2024