Pitolisant

Generic name: pitolisant [ pi-TOL-i-sant ]
Brand name: Wakix
Dosage form: oral tablet (17.8 mg; 4.45 mg)
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Drugs.com on Aug 9, 2024. 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 is also used to treat excessive daytime sleepiness caused by narcolepsy in children at least 6 years old.

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:

• pounding heartbeats or fluttering in your chest;

• dizziness, fainting;

• loss of consciousness; or

• hallucinations.

Common side effects of pitolisant may include:

• headache;

• nausea;

• anxiety; or

• sleep problems (insomnia).

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.

Related/similar drugs

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

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

• severe liver disease.

Tell your doctor if you have or have ever had:

• heart rhythm disorder;

• long QT syndrome (in you or a family member);

• liver disease; or

• kidney disease.

It is not known if pitolisant will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose. Tell your doctor right away if a pregnancy occurs.

Ask a doctor if it is safe to breastfeed while using pitolisant.

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.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

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

Comments:
-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?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

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.

Tell your doctor about all your other medicines, especially:

• medication used to treat or prevent allergies.

This list is not complete and many other drugs may affect pitolisant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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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.

Medical Disclaimer

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