Wakix FDA Approval History
Last updated by Judith Stewart, BPharm on June 24, 2024.
FDA Approved: Yes (First approved August 14, 2019)
Brand name: Wakix
Generic name: pitolisant
Dosage form: Tablets
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy
Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of narcolepsy.
- Wakix is indicated for the:
- treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.
- treatment of excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy. - Narcolepsy is a neurological disease of sleep-wake state instability characterized by excessive daytime sleepiness (EDS), with or without cataplexy. EDS is the inability to stay awake and alert during the day. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability.
- The exact way in which Wakix works in the treatment of narcolepsy is unclear, but it is thought its efficacy could be mediated through activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter.
- Wakix is administered orally, once daily in the morning upon wakening.
- Warnings and precautions associated with Wakix include QT interval prolongation.
- Common adverse reactions:
- in adults include insomnia, nausea, and anxiety.
- in pediatric patients 6 years and older include headache and insomnia.
Development timeline for Wakix
Further information
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