Wakix vs. Xyrem for Narcolepsy in Children: 7 Differences to Consider
Key takeaways:
Wakix (pitolisant) and Xyrem (sodium oxybate) are two medications approved for narcolepsy symptoms in children. Wakix comes as an oral tablet, while Xyrem comes as an oral solution.
Wakix is taken once daily first thing in the morning. It typically starts working within 1 to 2 weeks, but it can take up to 8 weeks for some people. Xyrem is taken at bedtime and requires 2 doses given at least 2.5 hours apart. It typically starts working within about 4 weeks.
Xyrem is a controlled substance, and it can be harmful if it isn’t taken properly. It requires extra steps from both you and your prescriber in order to fill a prescription. Wakix isn’t a controlled substance and doesn’t require extra steps. Both medications are typically filled through specialty pharmacies.
Table of contents
Narcolepsy is a condition that causes excessive daytime sleepiness. Symptoms can come at any time and may even include sudden muscle weakness that makes you collapse in place (cataplexy). For children, narcolepsy presents a unique challenge, as it remains difficult to diagnose and treat in kids. That’s where the medications Wakix (pitolisant) and Xyrem (sodium oxybate) come in.
Wakix and Xyrem are both approved to treat narcolepsy symptoms in children. If you're the parent of a child with narcolepsy, you may be wondering how to choose between them. Here, we'll compare Wakix versus Xyrem to help you make an informed decision.
1. Wakix and Xyrem come in different dosage forms
Wakix and Xyrem are both taken by mouth. But they come in different dosage forms.
Wakix comes as an oral tablet. It’s available in two different doses: 4.45 mg and 17.8 mg per tablet. Wakix tablets shouldn’t be crushed or chewed. This may present a problem if your child has trouble swallowing pills.
Xyrem comes as a concentrated oral solution (liquid). You’ll need to measure each dose and mix it with about ¼ cup of water before your child drinks it. This may be an easier option for kids who can’t swallow pills, but it requires more time and attention to properly measure and mix each dose.
2. Wakix and Xyrem are given at different times of day
Your child will take Wakix once daily in the morning, as soon as they wake up. They can take it with or without food. But taking Wakix with food can help lessen nausea caused by the medication.
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Xyrem, on the other hand, is taken at bedtime. Your child will take the first dose when they’re in bed and ready to go to sleep, at least 2 hours after eating. Then they’ll take a second dose 2.5 to 4 hours later. You may need to wake your child up to administer the second dose of Xyrem.
It’s not safe to give your child both Xyrem doses at once or less than 2.5 hours apart. Giving the second dose of Xyrem too soon after the first dose can be dangerous, as it can slow down your child’s breathing and heart rate to a dangerous level.
3. Wakix and Xyrem work differently to treat narcolepsy
Wakix and Xyrem treat narcolepsy in different ways.
Xyrem is approved for children age 7 and older. It treats both excessive daytime sleepiness and cataplexy symptoms. Xyrem works by improving nighttime sleep to help lessen sleepiness during the day. It does this through its effects on GABA receptors in the brain. Activating GABA receptors helps your child feel tired and go to sleep.
Wakix is approved for children age 6 and older. It’s approved to treat a few different symptoms in adults, but for children, it’s only approved to treat excessive daytime sleepiness. Wakix works by increasing histamine levels in the brain during the day. It’s common to think of antihistamines that make you sleepy, such as Benadryl (diphenhydramine), when you see the word “histamine.” Wakix basically has the opposite effect of these antihistamines. Instead of blocking histamine and making your child tired, it increases histamine to help them stay awake.
4. Xyrem is a controlled substance — Wakix isn’t
Another important difference is that Xyrem is a controlled substance, while Wakix isn’t.
Controlled substances are medications that carry a risk for dependence or misuse. There are restrictions on how they’re prescribed, dispensed, and refilled. And it’s important to store them safely out of the reach of children.
Not only is Xyrem a controlled substance, but it also carries a boxed warning (the FDA’s most serious warning) about the risk that it may slow down your breathing. This may make it a less appealing option to give to young children.
Wakix, on the other hand, is the first narcolepsy treatment that isn’t a controlled substance. A clinical trial found that Wakix had the same risk of dependence and misuse as a placebo (sugar pill). Wakix also doesn’t carry a boxed warning from the FDA.
Both Wakix and Xyrem are considered safe and effective for children when they’re administered as directed. Your pediatrician can discuss the risks and benefits of both medications with you and address any concerns.
5. Wakix and Xyrem have different side effects to consider
Wakix and Xyrem each come with different side effects. It’s a good idea to think about how these side effects may affect your child’s routine and well-being.
For children, the most common Xyrem side effects reported in clinical trials were nausea, bedwetting, and vomiting. Headache and decreased appetite were also common. Rarely, children taking Xyrem reported mood changes such as anxiety, depression, or suicidal thoughts.
The most common Wakix side effects reported in children included headache, insomnia, and nausea. Anxiety and irritability were also reported. Wakix can also raise the risk of an irregular heartbeat (arrhythmia) called long QT syndrome.
Other medications and certain heart conditions can increase the risk of certain side effects with Wakix or Xyrem. So it’s a good idea to review your child’s medication list and health history with your pediatrician when choosing a narcolepsy treatment.
6. Wakix may take longer to start working than Xyrem
As mentioned, both Wakix and Xyrem are effective narcolepsy treatments for children. But Wakix may take longer to work for some people.
You may start noticing your child’s symptoms improving within a week or two of starting Wakix. But for some children, it may take up to 8 weeks to start working. Part of the reason for this is that it takes 3 to 4 weeks to slowly increase the Wakix dosage up to the recommended daily amount.
With Xyrem, most people notice symptom improvement within the first 4 weeks or so of treatment. However, it can take 4 to 7 months for the medication to reach its full effect.
The main takeaway for either medication is that they can take some time to start working. So it’s OK if you don’t notice a change in your child’s symptoms right away.
7. There are extra steps required to receive Xyrem that aren’t required for Wakix
As mentioned above, Xyrem is a controlled substance that can be harmful if it isn’t taken properly. Because of that, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) program when prescribing it. REMS programs are designed to help ensure medications are prescribed and taken safely.
You, your prescriber, and your pharmacy must all be enrolled in the Xyrem REMS program before you can fill a prescription for it. In most cases, you’ll fill a Xyrem prescription through a specialty pharmacy. It typically can’t be filled by a local pharmacy. The specialty pharmacy will provide you with the information you need to complete your portion of the REMS program requirement.
Wakix doesn’t require a REMS program because it doesn’t carry the same risks as Xyrem. But like Xyrem, Wakix is a limited distribution drug that’s typically only dispensed by a specialty pharmacy.
How to save on Wakix and Xyrem
There are ways to save on Wakix and Xyrem. Both are available as brand-name medications. But you can also find Xyrem as a lower-cost generic. GoodRx can help you navigate ways to save on your prescription.
If you have commercial insurance, you may be eligible to pay as little as $0 for Wakix using a savings program from the manufacturer.
You may pay as little as $35 per month for brand-name Xyrem with a copay savings card if you have commercial insurance. A patient assistance program is also available if you’re uninsured or underinsured.
The bottom line
Wakix (pitolisant) and Xyrem (sodium oxybate) are oral medications approved to treat narcolepsy symptoms in children. Wakix is available as an oral tablet taken once daily in the morning, soon after waking up. Xyrem comes as an oral solution. It’s taken at bedtime and requires two doses, separated by at least 2.5 hours.
Xyrem is a controlled substance and requires extra steps from you and your prescriber to ensure you’re aware of its risks before you can fill your child’s prescription. Wakix isn’t a controlled substance and doesn’t have these requirements. Both Wakix and Xyrem are typically dispensed by a specialty pharmacy. Your pediatrician will work with you to help determine the best treatment option for your child.
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References
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