3 June 2021 - The Department of Health and Social Care has asked the NICE to produce guidance on using pitolisant hydrochloride in the NHS in England.

Pitolisant hydrochloride is not recommended, within its marketing authorisation, to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been satisfactorily treated by primary obstructive sleep apnoea therapy such as continuous positive airway pressure, or who cannot tolerate it.

Clinical trial evidence suggests that pitolisant hydrochloride reduces excessive daytime sleepiness, with and without continuous positive airway pressure. But there is uncertainty about the evidence because of the way the trials were done. They excluded some people who might be eligible for pitolisant hydrochloride in the NHS.

Read NICE appraisal consultation document