FDA label
What is Wakix used for?
Wakix contains pitolisant. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted Wakix?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Wakix, tablet, film coated
Indications and Usage, quoted from the label by Harmony Biosciences, LLC (NDA211150). Cross-references to other label sections are left out.
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
Source: DailyMed label, set id 8daa5562-824e-476c-9652-26ceef3d4b0e, version 18, effective February 13, 2026. NDC 72028-045, one of 2 listings for this product.
Questions
What is Wakix used for?
The FDA label says: “WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.”
What drug class is Wakix?
FDA lists pitolisant in the Histamine-3 Receptor Antagonist/Inverse Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.