Wakix® (Pitolisant Hydrochloride Tablets) is a selective histamine H3 receptor antagonist and inverse agonist. It enhances central histaminergic neurotransmission to promote wakefulness and regulate sleep-wake cycle.
Main Indications
Treatment of excessive daytime sleepiness in adult patients with narcolepsy, with or without cataplexy.
Clinical Research
Global multicenter clinical trials demonstrated that pitolisant significantly alleviates excessive daytime sleepiness and improves patients’ vigilance. Long-term follow-up studies verified stable therapeutic effects for narcolepsy management, showing better safety profile compared with traditional wake-promoting stimulants.
Common Side Effects
Frequently observed adverse reactions include insomnia, headache, nausea, anxiety and irritability.
Other reported reactions: upper abdominal pain, vertigo, sleep disturbance and weight variation. Rare serious adverse events include psychiatric disorders.
Approval Status in China
The domestic version Huakesi® (Pitolisant Hydrochloride Tablets) obtained marketing approval in China in 2025. Wakix® is the original overseas brand name, and this product is a prescription drug for narcolepsy.
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