Japan approves pitolisant for excessive daytime sleepiness in narcolepsy and sleep apnea

Japan's Ministry of Health, Labour and Welfare approved WAKIX, also known as pitolisant, on October 2, 2026, Sleep Review reported. The medication treats excessive daytime sleepiness in adults with narcolepsy as well as patients who have obstructive sleep apnea syndrome and are receiving treatment for airway obstruction. [1]

According to Sleep Review, the therapy is licensed to Viatris Inc for the Japanese market. It is an orally administered medication that functions as a histamine H3 receptor antagonist and inverse agonist. This approval marks the first non-controlled treatment option for excessive daytime sleepiness available in Japan for these conditions. [1]

Narcolepsy is a chronic neurological disorder that impairs the ability to regulate sleep and wake cycles, specifically impacting REM sleep. Symptoms include excessive daytime sleepiness, disturbed nocturnal sleep, sleep paralysis, sleep-related hallucinations, and cataplexy. [4]

Sleep Review noted that the approval covers both type 1 and type 2 narcolepsy, with and without cataplexy. The approval provides an additional prescription option for patients who experience excessive daytime sleepiness related to their sleep disorders. [1]