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WAKIX (pitolisant), histamine H3 inverse agonist/antagonist

NEUROLOGY - New medicinal product
Opinions on drugs - Posted on Oct 14 2016

Reason for request


Minor improvement in the management of narcolepsy with or without cataplexy.

  • WAKIX has Marketing Authorisation in the treatment of adults with narcolepsy with or without cataplexy.
  • In a single short-term study, it reduced daytime sleepiness versus placebo without demonstrating non-inferiority versus modafinil.
  • Its efficacy on cataplexy, another characteristic symptom of narcolepsy, was only demonstrated short-term versus placebo in very severe patients.

Clinical Benefit



Clinical Added Value



Therapeutic use


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