Uses
What is Wakix used for?
Wakix (pitolisant) is commonly used for narcolepsy, which includes excessive daytime sleepiness (EDS) and cataplexy.
How Wakix Works for Narcolepsy
Wakix may also be used for other conditions as determined by your healthcare provider.
How does Wakix work (mechanism of action)?
Wakix blocks a receptor in the brain called the histamine-3 (H3) receptor. This may change the way that the brain regulates sleep and wakefulness.
How is Wakix supplied (dosage forms)?
Wakix is available in the following dosage forms that are taken by mouth.
- 4.45 mg oral tablets
- 17.8 mg oral tablets
How should I store Wakix?
Wakix should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Wakix?
The most common side effects of Wakix are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Anxiety
- Headache (in children)
- Nausea
- Trouble sleeping (insomnia)
There may be other side effects of Wakix that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Wakix?
While less common, the most serious side effects of Wakix are described below, along with what to do if they happen.
Severe Allergic Reactions. Wakix may cause allergic reactions, which can be serious. Stop taking Wakix and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Heart Rhythm Changes. Wakix may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take some medicines for other heart rhythm problems. Your risk of heart rhythm problems caused by Wakix may be higher if you have liver or kidney problems. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.
Warnings & Precautions
Who should not use Wakix?
Allergies to Ingredients. People who are allergic to any of the following should not take Wakix.
- Pitolisant
- Wakix
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Wakix.
Serious Liver Problems. If you have serious liver problems, you should not take Wakix.
What should I know about Wakix before using it?
Do not take Wakix unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Wakix with other people, even if they have the same condition as you. It may harm them.
Keep Wakix out of the reach of children.
If you use hormonal birth control to prevent pregnancy, you may need to use a different form of birth control while you are taking Wakix and for 21 days after stopping Wakix. Speak with your healthcare provider about your other birth control options.
What should I tell my healthcare provider before using Wakix?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Wakix is right for you.
In particular, make sure that you discuss any of the following.
- A test showing that you are a “poor CYP2D6 metabolizer”
- Heart problems, including an abnormal heart rhythm
- Kidney problems
- Liver problems
- History of low potassium levels (hypokalemia)
- History of low magnesium levels (hypomagnesemia)
Other Medicines and Supplements. Wakix may interact with other medicines and supplements. Before using Wakix, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Wakix could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Wakix while you are pregnant or trying to get pregnant. If you become pregnant while taking Wakix, you can register for the Wakix pregnancy registry by calling 800-833-7460. This registry collects safety information about the use of Wakix during pregnancy.
Breastfeeding. Wakix passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Wakix while breastfeeding.
How can I get more information about Wakix?
For more information about Wakix, you can visit the manufacturer’s website at www.wakix.com or call them at 855-WAKIX4U (855-925-4948).
Interactions
Does Wakix interact with foods or drinks?
There are no known interactions between Wakix and foods or drinks.
It is unknown if drinking alcohol will affect Wakix.
Does Wakix interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Wakix.
- A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD)
- An antihistamine, such as chlorpheniramine or diphenhydramine (Benadryl), which is a medicine commonly used to treat allergy symptoms
- Medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
Many other medicines may alter the blood levels of Wakix, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Wakix. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Wakix?
If you or someone else has used too much Wakix, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Wakix?
If you miss a dose, wait until it is time to take your next dose the following morning. Do not take double or extra doses.