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Wakix

Generic name: pitolisant [ pi-TOL-i-sant ]
Dosage form: tablet (4.45 mg, 17.8 mg)
Drug class: CNS stimulants

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 9, 2023.

What is Wakix?

Wakix tablets are used to treat adults with excessive daytime sleepiness (EDS) or cataplexy (sudden loss of muscle strength) both are symptoms of narcolepsy, which is a long-term sleep disorder.

Wakix is thought to work by changing the amount of histamine in the area of the brain that controls sleep and wakefulness, as it acts on the histamine-3 (H3) receptor.

Narcolepsy is a disorder that affects how well the brain control sleep-wake cycles. Often people with narcolepsy have interrupted sleep and may feel very sleepy during the day, which interferes with their life. Everyone that has narcolepsy has excessive daytime sleepiness, which is when they have an overwhelming sense of sleepiness that comes on quickly.

Cataplexy is when you have a sudden loss of muscle tone while you are awake, which leads to muscle weakness and loss of muscle control. Cataplexy can be mild and only last a short time, or it can be severe with a full body collapse.

Wakix is the only FDA-approved medicine for narcolepsy medicine that is not a controlled substance treatment.

Wakix is not a stimulant medicine.

Warnings

You should not use Wakix if you have severe liver disease.

Before taking this medicine

You should not use this medicine if you are allergic to pitolisant or any of the inactive ingredients. Click here for a full list of ingredients.

You should not use Wakix if you have:

Tell your doctor if you have ever had:

Pregnancy

Ask a doctor before using this medicine if you are pregnant or planning a pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Wakix 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 this medicine.

Breastfeeding

Ask a doctor before using this medicine if you are breastfeeding or planning to breastfeed

Pitolisant 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 tablet is usually taken once daily when you wake up, it can be taken with or without food.

Your doctor will probably start you on a low dose and gradually increase your dose, not more than once every 7 days.

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.

Wakix dosage information

The recommended dosage range for Wakix is 17.8 mg to 35.6 mg taken once daily in the morning upon wakening.

The dosage should be increased gradually as follows:

Week 1: Start with a dosage of 8.9 mg (two 4.45 mg tablets) once daily

Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily

Week 3: Dose may increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily

Note: Dose may be adjusted based on tolerability.
It may take up to 8 weeks for some patients to achieve a clinical response.

Wakix is supplied as an oral tablet containing 4.45 mg or 17.8 mg of pitolisant.

 

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Wakix may cause serious side effects.

Call your doctor at once if you have:

Common side effects of Wakix may include

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 this medicine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Wakix 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 may affect 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.

To check for interactions with Wakix click on the link below.

Storage

Store at 20° C to 25° C (68° F to 77°F); excursions permitted between 15° C to 30° C (59° F to 86° F)

Ingredients

Active ingredient: pitolisant hydrochloride

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Company

Distributed by: Harmony Biosciences, LLC, Plymouth Meeting, PA 19462 USA Wakix is a registered trademark of Bioprojet Pharma.

Popular FAQ

Wakix (pitolisant) increases histamine levels in the brain. Histamine is a neurotransmitter (a natural chemical) in the brain that helps to promote wakefulness and stable muscle tone throughout the day. Wakix has activity as an antagonist/inverse agonist at the histamine-3 receptors found primarily in the brain, but its exact mechanism is not fully known. Wakix is not a stimulant drug like amphetamine and is not a controlled substance. Continue reading

No, Wakix is not a controlled substance. It was the first treatment approved for narcolepsy that was NOT classified as a controlled substance. It works by increasing the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. Continue reading

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Wakix only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.