FDA & Government News

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.

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    Pitolisant is now approved for pediatric narcolepsy patients aged 6 and older.

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    It treats excessive daytime sleepiness and cataplexy.

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    Approved in the US in 2019 for adults.

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    Functions as a histamine 3 receptor antagonist.

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    Contraindicated in patients with severe hepatic impairment.

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    Common side effects include headache and insomnia in children.

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    Narcolepsy affects approximately 170,000 individuals in the US.

Original Source(s)

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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