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Pitolisant

Brand names: Wakix

What is pitolisant used for?

  • Pitolisant is used to treat a lot of sleepiness during the day in patients with narcolepsy.

Before taking pitolisant, tell your doctor:

  • If you are allergic to pitolisant; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have any of these health problems: Low magnesium levels, low potassium levels, or slow heartbeat.
  • If you have ever had a long QT on ECG or other heartbeat that is not normal.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are taking any of these drugs: Clomipramine, diphenhydramine, imipramine, mirtazapine, pheniramine, or promethazine.

This is not a list of all drugs or health problems that interact with pitolisant.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pitolisant with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take pitolisant?

  • Tell all of your health care providers that you take pitolisant. This includes your doctors, nurses, pharmacists, and dentists.
  • It may take several weeks to see the full effects.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking pitolisant and for 3 weeks after stopping pitolisant.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is pitolisant best taken?

Use pitolisant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take in the morning.
  • Take pitolisant when you wake up.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of pitolisant that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with pitolisant. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of pitolisant?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Trouble sleeping.
  • Upset stomach.
  • Anxiety.
  • Signs of a common cold.
  • Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out pitolisant?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about pitolisant, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take pitolisant or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pitolisant. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated April 5, 2023.