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Generic name: pitolisant [ pi-TOL-i-sant ]
Brand name: Wakix
Dosage form: oral tablet (17.8 mg; 4.45 mg)
Drug class: CNS stimulants

Medically reviewed by on Oct 26, 2023. Written by Cerner Multum.

What is pitolisant?

Pitolisant is used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.

Pitolisant may also be used for purposes not listed in this medication guide.

Pitolisant side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pitolisant may cause serious side effects. Call your doctor at once if you have:

Common side effects of pitolisant may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


You should not use pitolisant if you have severe liver disease.

Before taking this medicine

You should not use pitolisant if you are allergic to it, or if you have:

Tell your doctor if you have ever had:

Ask a doctor before using pitolisant if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pitolisant on the baby.

Pitolisant can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pitolisant, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose of pitolisant.

Pitolisant is not approved for use by anyone younger than 18 years old.

How should I take pitolisant?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Pitolisant is usually taken once daily when you wake up.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Pitolisant dosing information

Usual Adult Dose for Narcolepsy:

Initial Up Titration: 8.9 mg orally once a day for 1 week, then 17.8 mg orally once a day for 1 week, then may increase to 36 mg orally once a day
-Adjust dose based on patient response and tolerability
Maintenance dose: 17.8 to 35.6 mg/day
Maximum dose: 35.6 mg/day

-Total dose should be administered as a single dose in the morning during breakfast.
-It may take up to 8 weeks for some patients to achieve a clinical response.

Use: For the treatment of excessive daytime sleepiness in patients with narcolepsy.

What happens if I miss a dose?

Skip the missed dose and use your next dose the following morning at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pitolisant?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect pitolisant?

When you start or stop taking pitolisant, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Pitolisant can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect pitolisant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Popular FAQ

Wakix (pitolisant) increases histamine levels in the brain. Histamine is a neurotransmitter (a natural chemical) in the brain that helps to promote wakefulness and stable muscle tone throughout the day. Wakix has activity as an antagonist/inverse agonist at the histamine-3 receptors found primarily in the brain, but its exact mechanism is not fully known. Wakix is not a stimulant drug like amphetamine and is not a controlled substance. Continue reading

No, Wakix is not a controlled substance. It was the first treatment approved for narcolepsy that was NOT classified as a controlled substance. It works by increasing the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. Continue reading

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.