Pitolisant Hydrochloride (Wakix)

Key Messages

• CADTH recommends that Wakix not be reimbursed by public drug plans for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
• It is still not known whether Wakix offers any therapeutic benefit over other treatments used for EDS or cataplexy. Two double-blind, randomized, controlled, comparative studies failed to show that Wakix was at least as good as modafinil for treating EDS and did not show any clinical benefit of Wakix over modafinil. One study focused on cataplexy, but this study was versus placebo and results were inconsistent for cataplexy outcomes across the studies.
• Based on the evidence, the expert committee could not conclude that Wakix met any of the needs that were identified as important to patients, including being more effective and reliable for controlling narcolepsy symptoms and to which patients would be less likely to develop tolerance.