WAKIX (Pitolisant)

What is this medication?

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.

How should I use this medication?

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.

Dosing 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 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.

How should I store this medication?

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)

What should I avoid while taking Wakix?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Wakix may cause serious side effects.

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 side effects of Wakix 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 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.