The approval follows domestic Phase 3 clinical trials and international research confirming the drug's efficacy in patients managing sleep disorders. For those with obstructive sleep apnea, excessive daytime sleepiness often persists despite standard airway obstruction therapies, creating a significant medical gap. Similarly, narcolepsy patients—both with and without cataplexy—frequently struggle with impaired wakefulness that impacts daily productivity and quality of life.

Philippe Martin, Chief R&D Officer at Viatris, noted that the drug represents a strategic advancement for sleep medicine in the region. Unlike some existing treatments for these conditions, WAKIX is not classified as a controlled substance. Originally discovered by Paris-based Bioprojet, the medication is licensed to Viatris for the Japanese market. The drug has already seen adoption in over 38 countries for narcolepsy and more than 29 for sleep apnea-related symptoms, with orphan drug designation in Japan further underscoring its clinical role.