Frequently Asked Questions
Learn more about WAKIX
Whether you're newly diagnosed with narcolepsy or have been diagnosed for years and are ready for a change, find the answers to your questions about WAKIX and narcolepsy below.
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Narcolepsy with cataplexy is usually called narcolepsy type 1. Narcolepsy without cataplexy is usually called narcolepsy type 2. All people living with narcolepsy have excessive daytime sleepiness (EDS), and nearly 2 out of 3 people with narcolepsy may have cataplexy. Find out more about narcolepsy.
There are many types of healthcare providers that can help manage your narcolepsy. Some of these providers include sleep specialists, neurologists, psychiatrists, pulmonologists, primary care doctors (PCPs), nurse practitioners, and physician assistants.
The main symptom of narcolepsy is excessive daytime sleepiness (EDS), which is the persistent feeling of tiredness. All people with narcolepsy have EDS, but each person may describe his or her EDS differently. Learn more about how people may describe EDS.
Cataplexy is the sudden onset of weak or paralyzed muscles and is usually brought on by strong emotions or certain situations. Nearly 2 out of 3 people with narcolepsy may also have cataplexy, but it may be difficult to recognize. Learn more about what cataplexy can feel like.
Cataplexy can cause people with narcolepsy to collapse completely, but more often it affects specific areas of the body. It’s not always obvious that the experiences of cataplexy are related to narcolepsy. Talk to your healthcare provider if you think you may have cataplexy. Learn more about what cataplexy can feel like.
WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. You do not have to have both EDS and cataplexy to take WAKIX.
The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age. Learn more about WAKIX.
WAKIX was initially approved by the FDA for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy in August 2019 and received an additional FDA approval for cataplexy in adults with narcolepsy in October 2020. Learn more about WAKIX.
WAKIX is a first-of-its-kind medication. While the way WAKIX works is not fully understood, it is thought that WAKIX reduces excessive daytime sleepiness (EDS) or cataplexy by increasing histamine levels in the brain. Watch a video of how WAKIX is thought to work.
WAKIX is not a controlled substance. A controlled substance is a drug or chemical that is regulated by the government based on its potential for abuse or dependence.
WAKIX is not a stimulant.
WAKIX prescriptions are filled through a Specialty Pharmacy, which may be different than how you’ve received other prescription medications. The Specialty Pharmacy will ship WAKIX to the location of your choice. A Specialty Pharmacy is different from a traditional pharmacy, or retail pharmacy. Specialty Pharmacies are often used for diseases or disorders that have smaller groups of people and where additional financial support might be needed. Understand what happens after WAKIX is prescribed for you.
Eligible patients may pay as little as a $0 copay on their WAKIX prescription with the WAKIX for You Program. This offer is valid only for patients who have commercial (nongovernment-funded) insurance. Additional terms and conditions apply. Once you are prescribed WAKIX, you have the option to sign up for the WAKIX for You patient support program. This program provides individual reimbursement and financial support based on your specific needs and eligibility. Contact WAKIX for You at 1-855-WAKIX4U (1-855-925-4948) Monday through Friday, 8 AM to 8 PM Eastern Time. Learn more about WAKIX for You.
Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease. WAKIX may not be right for patients with certain heart or other medical conditions or taking certain medications. Talk to your healthcare provider for more information.
In the clinical trials of adults with narcolepsy, the most common side effects for WAKIX compared with placebo were insomnia, nausea, and anxiety.
Other side effects in the clinical trials that occurred in people taking WAKIX included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, and decreased appetite.
These are not all of the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away. Learn more about possible WAKIX side effects.
Everyone responds to medication differently. It's important to know that WAKIX may take some time to work, and for some patients, it may take up to 8 weeks to achieve a response. Talk to your healthcare provider about what to expect when taking WAKIX. Learn more about what to expect when taking WAKIX.
WAKIX tablets are taken once daily in the morning, as soon as you wake up. Titration means that your healthcare provider will start you at a lower dose and may increase it each week to find the dose that’s right for you. Always take WAKIX exactly as your healthcare provider has prescribed. Learn more about the dosing for WAKIX.
If you miss a dose, take the next dose the following morning as soon as you wake up. If you have any more questions, talk with your healthcare provider.
Some antihistamines can prevent histamine from working in the brain. These medications may reduce the effectiveness of WAKIX and should be avoided. Your healthcare provider can tell you which antihistamines to avoid and may be able to provide suggestions about what antihistamines or alternative treatments can be taken with WAKIX. Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Learn what role histamine plays in the brain.
WAKIX may reduce the effectiveness of hormonal contraceptives (birth control). Women who can become pregnant should use an alternative non-hormonal type of birth control while taking WAKIX and for at least 21 days after discontinuation of treatment.
Talk to your healthcare provider if you are pregnant or planning to become pregnant. WAKIX has a voluntary registry that helps researchers learn more about the safety of WAKIX when used during pregnancy. You are encouraged to enroll in the WAKIX Pregnancy Registry if you are pregnant or become pregnant while taking WAKIX. For more information about the registry or to enroll, call the WAKIX Pregnancy Registry Coordination Center at 1-877-302-2813 or visit WakixPregnancyRegistry.com.
Indications and usage & Important Safety Information
Important Safety Information
Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or 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 at 1-800-833-7460.
Indications and Usage
WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or sudden onset of weak or paralyzed muscles (cataplexy) in adults with narcolepsy.
Please see Full Prescribing Information.
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