People with narcolepsy often need to take medicines to manage their symptoms. Many of these medicines carry a high risk for abuse or misuse, so there are restrictions on how they are prescribed and used. Some of these medicines also carry a risk for serious side effects.
Wakix is a unique medicine that is approved for the treatment of narcolepsy but does not carry a risk for abuse or misuse. As of 2024, this medicine is approved for use in people with narcolepsy who are at least 6 years old.
How Does Wakix Work for Narcolepsy?
Although many people struggle with drowsiness and getting enough sleep at some point in their lives, some people have sleep disorders that cause chronic (long-term) issues with sleep. These types of sleep disorders are caused by changes in the way that the brain processes and responds to sleep.
One of these disorders, narcolepsy, causes extreme sleepiness during the day and difficulty focusing or staying awake. As a result, many people with narcolepsy experience sleep attacks in which they fall asleep without warning, even if they are in the middle of an activity. Some people with narcolepsy also experience something called cataplexy. During a cataplexy attack, a person suddenly loses muscle control. This can cause all types of issues depending on which muscles are affected, from drooping eyelids, to difficulty speaking, to not being able to move at all.
Getting more sleep at night does not help with these symptoms, so treatment may include different types of medicines. One type of medicine that is often used to treat narcolepsy is sodium oxybate, or gamma-hydroxybutyrate (GHB). This medicine is taken at night and seems to change the way the brain responds to sleep so that a person feels less tired during the day. However, it can cause serious side effects and carries a high risk of abuse or misuse, so there are restrictions on prescribing and taking this medicine.
Many of the other medicines used for narcolepsy are stimulants, which are taken in the morning to make a person feel more awake during the day. These medicines also carry a high risk for abuse and misuse, so there are restrictions on prescribing and taking these medicines as well.
Wakix is not a stimulant and is not at high risk for abuse or misuse. The active ingredient in Wakix, called pitolisant, blocks a certain receptor in the brain called the histamine-3 (H3) receptor. This forces a chemical called histamine to bind to other receptors in the brain instead, changing the way that the brain regulates sleep and wakefulness.
How Do I Use It?
Wakix is a tablet that is taken by mouth every morning, right after waking up. If the morning dose is missed, it should not be taken later in the day. Wait until the next morning to take another dose.
When you start taking Wakix, you will start on a low dose. After 1 week, your dose will be increased. If you tolerate this higher dose well for a week, then your health care provider may increase your dose again. Depending on how well you tolerate the medicine, your dose may be adjusted up or down over time.
How Was It Studied for Treating Narcolepsy in Adults?
Three studies were done to see if Wakix was safe and effective for adults with narcolepsy. Everyone in these studies had narcolepsy with excessive daytime sleepiness. About half of the people in these studies were male and about half were female, with an average age of about 37. The race of the people in two of the studies was not reported. The other study reported that most (94%) of the people were White, but it did not report on the race of the other people in the study.
Two of the studies required everyone to have narcolepsy but not cataplexy:
- These studies compared Wakix with a placebo or another medicine called modafinil (Provigil), which is a stimulant that is approved for use in people with narcolepsy. No one knew if they were receiving Wakix, modafinil, or a placebo.
- These studies evaluated effectiveness by measuring symptoms of sleepiness on a scale that asks people to rate how likely they are to fall asleep in different situations. Scores can range from 0-24, with higher scores meaning a person is more likely to fall asleep in many situations.
In the third study, everyone had narcolepsy and cataplexy.
- This study compared Wakix with placebo, and no one knew which one they were receiving.
- The study measured efficacy by counting the number of cataplexy attacks people had each week.
What Were the Benefits in Adults?
Sleepiness score. After 8 weeks, the people who took either Wakix or modafinil had lower sleepiness scores than the people who took placebo. This means that both of these medicines have similar benefits for reducing sleepiness, and both work better than placebo.
Number of cataplexy attacks (adults). The number of cataplexy attacks each week before the study started was compared to the number of attacks each week after the study started. The people who were taking Wakix had only about one-quarter (25%) as many cataplexy attacks as they did before the study started. The people who took placebo had about two-thirds (62%) as many cataplexy attacks as they did before the study started. This means that Wakix was more effective than placebo for reducing the number of cataplexy attacks each week.
How Was It Studied in Children?
One study was done to see if Wakix was safe and effective for treating narcolepsy in children who were 6-17 years old. Everyone in this study had narcolepsy, with or without cataplexy, and the average age was about 14. About half of the children were male and about half were female. The race of the children in this study was not collected or reported.
This study compared Wakix with placebo, and no one knew which one they were receiving. Efficacy was measured using a scale that asked patients or parents to rate how often certain symptoms have occurred. Scores can range from 0-44, with a score above 14 meaning that a person probably has narcolepsy.
After 8 weeks in the study, the children who took Wakix had a lower score on the narcolepsy symptom scale than the children who took placebo. This means that Wakix helped to reduce symptoms more than placebo.
How Quickly Will Wakix Work for Narcolepsy?
When you start taking Wakix, you will need to increase your dose over 2-3 weeks, so it may not begin to work right away. Some people will notice their symptoms improve within the first 2-3 weeks of taking the medicine. However, other people may need to take the medicine for 6-8 weeks before they notice an improvement in their symptoms.
If your symptoms are not improving, do not increase your dose or stop taking the medicine without talking to your health care provider first. If you are concerned that Wakix is not working for you, your health care provider can discuss whether a higher dose or another treatment option may be best.
How Can I Prevent or Manage Side Effects?
Wakix may cause a rare, dangerous heart rhythm problem called QT prolongation. Before you start using Wakix, let your health care provider know if you or anyone in your family has a history of this condition. It is also important to let them know if you have a history of low potassium or magnesium levels or a history of kidney or liver problems, since this can increase your risk of this side effect. Once you have started taking Wakix, tell your health care provider right away if you faint or have changes in your heart rate or rhythm.
Some people who take Wakix have had trouble with falling asleep or waking up in the middle of the night. To help reduce the risk of this happening, make sure to take Wakix right when you wake up in the morning. If you forget to take it first thing in the morning, do not take it later in the day.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Wakix, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
There are many medicines that can alter blood levels of Wakix, and Wakix can alter the blood levels of many other medicines. It is important for your health care provider to be aware of every medicine you are taking before you start using Wakix. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them to determine the best treatment plan for you.
It is especially important to let your doctor know if you are using any antihistamines, such as chlorpheniramine and diphenhydramine (Benadryl), which are commonly used to treat allergy symptoms. These medicines may make Wakix less effective.
What Are Other Unique Considerations to Be Aware Of?
If you are using a hormonal birth control method, Wakix may make your birth control less effective. Talk with your health care provider about your options. A non-hormonal form of birth control should be used while taking Wakix and for at least 3 weeks after stopping Wakix.
Are There Any Special Steps Required to Get Wakix?
Wakix is a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at wakix.com/wakix-for-you-support-program.
