Wakix
Wakix (pitolisant) is a medication that treats excessive daytime sleepiness in adults and children ages 6 and older with narcolepsy. It's also used to treat cataplexy, or sudden muscle weakness after having strong emotions, in adults with narcolepsy. This medication is taken by mouth once a day in the morning. You'll typically start the medication at a lower dose and then slowly raise the dose over time. Side effects include headache, nausea, and trouble sleeping.
What is Wakix (pitolisant)?
What is Wakix (pitolisant) used for?
Excessive daytime sleepiness or cataplexy (sudden muscle weakness) in adults with narcolepsy
Excessive daytime sleepiness in children ages 6 and older with narcolepsy
How Wakix (pitolisant) works
Wakix (pitolisant) is a histamine-3 (H3) receptor antagonist/inverse agonist. It's not entirely clear how the medication works to treat daytime sleepiness and cataplexy in people with narcolepsy. But it's thought to work by raising histamine levels in your brain, which helps you stay awake.
Drug Facts
More on Wakix (pitolisant) essentials
What are the side effects of Wakix (pitolisant)?
Common Side Effects
- Headache (18%)
- Trouble sleeping (6%)
- Nausea (6%)
- Anxiety (5%)
- Headache (19%)
- Trouble sleeping (7%)
Other Side Effects
- Upper respiratory infection
- Muscle, bone, or joint pain
- Fast heart rate
- Seeing or hearing things that aren't there
- Irritability (cranky mood)
- Stomach pain
- Poor appetite
Serious Side Effects
- Abnormal heart rhythm (QT prolongation): chest pounding, irregular heartbeat, chest pain, short of breath, feeling faint or lightheaded
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Wakix (pitolisant)
Pros
Lowers how many cataplexy attacks you get per week
A narcolepsy treatment that's not a controlled substance
Only need to take it once a day
Cons
Not the best medication if you have liver or kidney problems
Might need to take more than one tablet for your dose
Can take a couple months to see the full effects of this medication
Pharmacist tips for Wakix (pitolisant)
Wakix (pitolisant) comes in two different tablet strengths: 4.45 mg and 17.8 mg. Depending on your dose, you might need to take more than one tablet at a time. Talk with your prescriber or pharmacist if you're unsure about how many tablets you need to take for each dose.
Take Wakix (pitolisant) in the morning when you first wake up, with or without breakfast. Food doesn't affect the way the medication works.
If you wake up and forget to take your Wakix (pitolisant) dose, it's recommended that you skip that dose. Take your next dose the following morning when you wake up. Don't double up on missed doses because this can raise your risk of side effects.
Before you start Wakix (pitolisant), make sure to tell your prescriber and pharmacist about all the medications you take. And once you start treatment, tell them about any new medications you plan to take. Wakix (pitolisant) interacts with a lot of common medications, including antihistamines, heart medications like amiodarone (Pacerone), and sertraline (Zoloft). Some medications can either make Wakix (pitolisant) work less well or raise your risk of side effects.
Wakix (pitolisant) can make hormonal birth control not work as well. Using a nonhormonal form of birth control (like condoms or spermicide) during treatment and for at least 3 weeks after stopping the medication if you use birth control.
Frequently asked questions about Wakix (pitolisant)
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What are the risks and warnings for Wakix (pitolisant)?
Wakix (pitolisant) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Life-threatening abnormal heart rhythm (QT prolongation)
Risk factors: History of heart problems | Heart rhythm problem called long QT syndrome | Taking medications that can affect heart rhythm | Liver or kidney problems | Low potassium or low magnesium
In some people, Wakix (pitolisant) can cause heart rhythm changes called QT prolongation, which can be life-threatening. Avoid this medication if you have a history of heart problems or if you're taking other medications that cause changes in heart rhythm. In addition, having severe liver or kidney problems can lead to higher levels of Wakix (pitolisant) in the body, which can also raise your risk of having heart problems. Talk to your provider about your medical history, including your heart health and all the medications you take. Seek medical help immediately if you feel faint or have an irregular heartbeat while you're taking Wakix (pitolisant).
Wakix (pitolisant) dosage forms
Typical dosing for Wakix (pitolisant)
You'll typically start Wakix (pitolisant) at a lower dose, and the dose will be slowly increased over time.
Adults:
Week 1: The typical starting dose is 8.9 mg by mouth once a day in the morning.
Week 2: Your prescriber will raise the dose to 17.8 mg by mouth once a day in the morning.
Week 3: If needed, your prescriber might raise your dose to a maximum of 35.6 mg once a day in the morning.
Children:
Week 1: The typical starting dose is 4.45 mg by mouth once a day in the morning.
Week 2: Your child's pediatrician will raise the dose to 8.9 mg by mouth once a day in the morning.
Week 3: Your child's pediatrician will raise the dose to 17.8 mg by mouth once a day in the morning.
Week 4: For those who weigh 40 kg (88 lbs) or more, if needed, your child's pediatrician might raise the dose to a maximum of 35.6 mg once a day in the morning.
Your dose might differ if you have kidney or liver problems, if you're taking a medication that interacts with Wakix (pitolisant), or if you have certain genetics that affects how well your body gets rid of Wakix (pitolisant).
More on Wakix (pitolisant) dosage forms
Wakix (pitolisant) contraindications
Severe liver problems
What is the latest news about Wakix (pitolisant)?
Wakix (pitolisant) images
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References
Best studies we foundAdamkovic, A., et al. (2023). 0909 pitolisant pregnancy registry: An observational study of the safety of pitolisant exposure in pregnant women and their offspring. Sleep.
Dauvilliers, Y, et al. (2019). Long-term use of pitolisant to treat patients with narcolepsy: Harmony III study. Sleep.
Harmony Biosciences, LLC. (2024). Wakix- pitolisant hydrochloride tablet, film coated [package insert]. DailyMed.
Meskill, G. J., et al. (2022). Clinical impact of pitolisant on excessive daytime sleepiness and cataplexy in adults with narcolepsy: An analysis of randomized placebo-controlled trials. Central Nervous System Drugs.
Meskill, G. J., et al. (2022). Pitolisant for the treatment of cataplexy in adults with narcolepsy. Expert Opinion on Orphan Drugs.
National Institute of Neurological Disorders and Stroke. (2023). Narcolepsy.
Newsom, R., et al. (2023). Cataplexy. SleepFoundation.
Pagel, J.F. (2009). Excessive Daytime Sleepiness. American Family Physician.
Sarfraz, N., et al. (2022). Pitolisant, a novel histamine-3 receptor competitive antagonist, and inverse agonist, in the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Health Psychology Research.
Watson, N. F., et al. (2021). Time to onset of response to pitolisant for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy: An analysis of randomized, placebo-controlled trials. Central Nervous System Drugs.
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