Generic name: pitolisant (pi TOL i sant)
Brand name: Wakix
Drug class: CNS stimulants
Wakix (pitolisant) is an antagonist/inverse agonist of the histamine-3 receptor.
Wakix is used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.
Wakix is supplied as an oral tablet containing 4.45 mg or 17.8 mg or pitolisant.
Warnings
You should not use Wakix if you have severe liver disease.
Before taking this medicine
You should not use Wakix if you are allergic to pitolisant, or if you have:
- severe liver disease.
To make sure Wakix is safe for you, tell your doctor if you have:
- liver disease;
- kidney disease;
- a heart rhythm disorder; or
- long QT syndrome (in you or a family member).
Ask a doctor before using Wakix 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 this medicine, 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.
Wakix is not approved for use by anyone younger than 18 years old.
How should I take Wakix?
Take Wakix exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Wakix 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.
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 Wakix?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Wakix side effects
Get emergency medical help if you have signs of an allergic reaction to Wakix: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast or pounding heartbeats;, fluttering in your chest;
- shortness of breath; or
- sudden dizziness (like you might pass out).
Common Wakix side effects may include:
- 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.
What other drugs will affect Wakix?
When you start or stop taking Wakix, 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 interact with 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.