FDA Broadens Pitolisant Label - Takeaways - MDSpire

FDA Broadens Pitolisant Label

The US Food and Drug Administration approves pitolisant (WAKIX) tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy.

  • By

  • Kathryn Wighton

  • February 17, 2026

  • 2 min

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  • 1

    Pitolisant is the only non-scheduled therapy approved in the US for narcolepsy in both pediatric and adult patients.

  • 2

    The FDA approved pitolisant for treating excessive daytime sleepiness and cataplexy in patients aged 6 years and older.

  • 3

    Pitolisant was initially approved in 2019 for excessive daytime sleepiness in adults and expanded to include cataplexy in 2020.

  • 4

    The drug acts as a selective histamine 3 receptor antagonist, promoting wakefulness through increased histamine release.

  • 5

    Common adverse reactions include insomnia, nausea, and anxiety in adults, while pediatric patients report headaches and insomnia.

Original Source(s)

FDA Broadens Pitolisant Label

  • by Kathryn Wighton

  • February 17, 2026

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