How does Wakix work for narcolepsy?

Wakix (pitolisant) treats narcolepsy by increasing histamine levels in the brain. Histamine is a neurotransmitter (a brain chemical messenger) that helps promote wakefulness and stable muscle tone throughout the day. Wakix has activity at histamine-3 (H₃) receptors to increase release of histamine, but its exact mechanism is not fully known.

Can Wakix be used in children?

Wakix is approved for:

• the treatment of excessive daytime sleepiness (EDS) or cataplexy (sudden loss of muscle strength) in adults patient with narcolepsy.
• the treatment of excessive daytime sleepiness in children 6 years of age and older with narcolepsy.

Narcolepsy is characterized by immense daytime drowsiness and sudden attacks of sleep. Cataplexy is a sudden, brief loss of voluntary muscle tone often triggered by strong emotions like laughter.

In the brain, histamine is a neurotransmitter (natural chemical messenger) that is important for wakefulness. Wakix binds strongly to H3 receptors. H3 receptors help to regulate the production and release of histamine in the brain.

Wakix is available as an oral tablet and is usually taken once daily when you wake up. Doses are slowly increased when you first start treatment. It may take up to 8 weeks before your symptoms improve.

Wakix is not classified as a controlled substance and it is not a stimulant.

The most common side effects of Wakix in adults include trouble sleeping, nausea, and anxiety and in children 6 years and older are headache and trouble sleeping.

Do not take Wakix if you have severe liver disease. Its use is not recommended in patients with end-stage renal disease (ESRD).

Wakix can cause a change in the electrical activity of the heart known as QT prolongation. Tell your doctor right away if you have a change in your heartbeat, pulse or if you feel dizzy or faint while taking this medicine.

Related questions

• Is Wakix a controlled substance?
• Can you have narcolepsy and insomnia?
• What are the early signs of narcolepsy?

Can I take an antihistamine with Wakix?

Certain prescription or over-the-counter (OTC) medicines can prevent histamine from working to promote wakefulness and may reduce the effectiveness of Wakix. You should avoid centrally acting H1 receptor antagonists. Examples of these medicines include:

• pheniramine maleate
• diphenhydramine (example: Benadryl)
• promethazine (antihistamines)
• imipramine
• clomipramine
• mirtazapine (tri- or tetracyclic antidepressants)

Ask your pharmacist about possible drug interactions with Wakix each time you start a new prescription, over-the-counter, vitamin or herbal medication.

Related: Wakix drug interactions (in more detail)

Does Wakix affect birth control?

• Yes, the effectiveness of hormonal birth control (for example: ethinyl estradiol) may be reduced when used with Wakix and for 21 days after discontinuation of therapy.
• This is due to the increased effect (induction) of the CYP450 3A4 enzyme leading to greater metabolism (break down and excretion) of estrogens and progestins by pitolisant (Wakix) and its main metabolites.
• Use an alternative non-hormonal birth control method (for example: a condom or diaphragm) during treatment with Wakix and for at least 21 days after you stop treatment.

Ask your healthcare provider if you questions about effective birth control methods.

This is not all the information you need to know about Wakix (pitolisant) for safe and effective use and does not take the place of your healthcare provider's instructions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.