Narcolepsy Rx Gets Green Light

FDA approves Wakix (pitolisant) for daytime sleepiness tied to narcolepsy

(RxWiki News) The US Food and Drug Administration (FDA) has approved a medication for narcolepsy.

This new approval can be found under the names Wakix (brand) and pitolisant (active ingredient). The FDA approved this medication to treat excessive daytime sleepiness (EDS) in adults with narcolepsy.

EDS is one of the most common symptoms of narcolepsy. Those with narcolepsy often feel tired during the day. They will often have trouble concentrating and staying awake, even if they have gotten a full night’s rest the prior night.

Because pitolisant works differently than other narcolepsy medications, it offers patients another option to treat their condition.

This medication is available in tablets and is to be taken once a day upon waking up in the morning. The dose is to be titrated over three weeks — up to a maximum dose of 35.6 mg. It may take patients up to eight weeks to see the effects of this medication.

Common side effects of pitolisant include insomnia (difficulty falling or staying asleep), nausea and anxiety.

This medication can cause serious side effects. These can include QT interval prolongation, which affects the heart’s electrical activity. This medication may not be an option if you currently have risk factors for QT interval prolongation or if you are taking medications known to cause this condition.

Wakix is not safe for everyone. Those with severe liver dysfunction are not to take this drug. Additionally, pitolisant can interact with several medications. Always tell your doctor about all of the medications you take. This includes prescription, over-the-counter and herbal drugs, as well as nutritional supplements.

The FDA granted approval of Wakix to Harmony Biosciences. Ask your health care provider any questions you have about this medication.

Written by Anyssa Garza, PharmD, BCMAS

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