Wakix (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.
warnings
What is the most important information I should know about Wakix (Pitolisant)?
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 this medicine.
Side Effects
What are the side effects of Wakix (Pitolisant)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
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 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.
Pregnancy & Breastfeeding
Can I take Wakix (Pitolisant) if I’m pregnant or breastfeeding?
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 this medicine.
Interactions
What drugs and food should I avoid while taking Wakix (Pitolisant)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Wakix (Pitolisant)?
Use Wakix (Pitolisant) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Skip the missed dose and use your next dose the following morning at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Wakix (Pitolisant)?
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