Clinical Trial Results | WAKIX® (pitolisant) tablets

WAKIX Clinical Trial Results

WAKIX reduced EDS

WAKIX® (pitolisant) was studied in two clinical trials in 159 adults with narcolepsy.

  • The effect of WAKIX was compared with placebo (sugar pill) for the treatment of excessive daytime sleepiness (EDS) using a scale called the Epworth Sleepiness Scale (ESS)

    • In the trials, 97 people were treated with WAKIX, and 62 people received placebo

The majority of patients in the trials reported severe EDS (ESS score ≥16), which means they had a high chance of dozing or falling asleep in everyday situations, such as:

  • Reading

  • Watching TV

  • Sitting and talking

In clinical trials, WAKIX showed significantly greater improvement in ESS score compared with placebo

An improvement in ESS score means a lower chance of dozing or falling asleep in everyday situations.

  • Everyone responds to medication differently. Individual responses varied in the clinical trials.

Trial 1 was 8 weeks and included 61 adults with narcolepsy (31 people were treated with WAKIX and 30 received placebo). About 80% of the people in the trial had cataplexy, another common symptom of narcolepsy, and about 20% did not.

Trial 2 was also 8 weeks and included 98 adults with narcolepsy (66 people were treated with WAKIX and 32 received placebo). In this trial, 75% of people had cataplexy and 25% did not.

WAKIX is a once-daily tablet
taken in the morning

Learn what 
else 
to expect >

What are the possible side
effects of WAKIX?

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Indications and usage & Important Safety Information

Important Safety Information

Do not use WAKIX if you have severe liver disease.

Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. Tell your healthcare provider about all the other medicines you take.

The risk of QT prolongation may be greater in patients with liver or kidney disease. WAKIX is not recommended in patients with end-stage kidney disease.

The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. The dosage of WAKIX may need to be adjusted if you are taking these medicines.

WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.

Tell your healthcare provider if you are pregnant or planning to become pregnant. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. To enroll or obtain information from the registry, call 1-800-833-7460.

The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report negative side effects to Harmony Biosciences, LLC at 1-800-833-7460.

Please see Full Prescribing Information.

Indications and Usage

WAKIX is a prescription medicine for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

Indications and usage & Important Safety Information

Important Safety Information

Do not use WAKIX if you have severe liver disease.

Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. Tell your healthcare provider about all the other medicines you take.

The risk of QT prolongation may be greater in patients with liver or kidney disease. WAKIX is not recommended in patients with end-stage kidney disease.

The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. The dosage of WAKIX may need to be adjusted if you are taking these medicines.

WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.

Tell your healthcare provider if you are pregnant or planning to become pregnant. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. To enroll or obtain information from the registry, call 1-800-833-7460.

The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report negative side effects to Harmony Biosciences, LLC at 1-800-833-7460.

Please see Full Prescribing Information.

Indications and Usage

WAKIX is a prescription medicine for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

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