Pitolisant is a drug designed to promote wakefulness and so reduce excessive daytime sleepiness (EDS), whilst also resulting in a significant reduction in cataplexy. This dual action may be because it works by increasing the activity of histamine neurons in the brain, a mechanism that is completely different to most classic stimulants. There is also some evidence that Pitolisant helps reduce the symptoms of idiopathic hypersomnia.

Pitolisant was approved by the European Medicines Agency in March 2016. Anecdotal feedback from patients suggests that it may cause fewer side-effects than regular stimulants and promotes a more ‘natural wakefulness’. As it is an oral medication taken in tablet form, it also offers a simpler and less disruptive dosing schedule than that of sodium oxybate. As a new medication covered by a patent, however, it is much more expensive than other stimulants and remains difficult for patients to access.

Pitolisant is only produced by one company (Harmony Biosciences, Wakix®). It is a tablet, which comes in two strengths (4.5mg and 18mg) and is taken once a day, with breakfast.

Pitolisant – BNF

Side effects

As with any medication, the drugs used to treat narcolepsy can have side-effects. These can take many forms. They may be relatively minor, such as mild headaches or a dry mouth, or much more serious, such as anxiety or depression. You should check the Patient Information Leaflet (PIL) in the packaging of your medication for more details and if you experience any of these side-effects (or any not on the PIL) you should consult your doctor or pharmacist.

You can also report side effects directly via the Yellow Card Scheme. By reporting side effects, you can help improve the safety of this medicine.


Evangelista, E. et al. (2018) Expert Opin. Investig. Drugs 27: 187-192

Szakacs, Z. et al. (2017). Lancet Neurology 16: 200-207