Key TakeawaysThe Food and Drug Administration (FDA) approvedXywavto treat adults with idiopathic hypersomnia, a rare sleep disorder where an individual does not get rest from sleeping.There are no other drugs approved in the United States to treat idiopathic hypersomnia.Xywav will only be available through certified healthcare providers and pharmacies.

Key Takeaways

The Food and Drug Administration (FDA) approvedXywavto treat adults with idiopathic hypersomnia, a rare sleep disorder where an individual does not get rest from sleeping.There are no other drugs approved in the United States to treat idiopathic hypersomnia.Xywav will only be available through certified healthcare providers and pharmacies.

The drug was already approved to treat adults and children over the age of 7 years with narcolepsy and cataplexy orexcessive daytime sleepiness. This approval marks a new use for the drug.

What Is Hypersomnia?

“Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” Eric Bastings, MD, the deputy director of the Office of Neuroscience at the Center for Drug Evaluation and Research, said in astatementfrom the FDA.

Bastings added that “a novel indication for Xywav is significant as the FDA has never granted an approval for idiopathic hypersomnia.”

What Is Idiopathic Hypersomnia?

What to Know About Xywav

Xywav is an oral mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. Oxybate is another name for gamma-hydroxybutyrate (GHB), which depresses the central nervous system.

GHB is sometimes used illicitly as a “date rape” drug that can easily be slipped into a drink to make someone unconscious.

Xyrem is approved for the treatment of cataplexy and excessive daytime sleepiness. Each dose of Xyrem contains a large amount of sodium—more than the daily recommended level of sodium in the higher doses. Xywav has far less sodium per dose than Xyrem.

Xywav received FDA approval for the treatment of idiopathic hypersomnia after the agency reviewed the data from a clinical study that included 154 adult patients with the condition.

Why Do I Feel Sleepy All Day?

During the trial, the patients were randomly put into two groups. Some continued taking Xywav, and others were switched to a placebo. Researchers found that patients who were switched to placebo experienced worse sleep and more idiopathic hypersomnia symptoms than the patients who took Xywav.

The FDA gave XywavFast Track, Priority Review, and Orphan Drug designations, which speeds up the approval process.

How to Take Xywav

Xywav is a concentrated solution that must be diluted with water. The drug’s manufacturer advises patients to take the diluted drug once they are already in bed because it can take effect within five minutes and the onset of sleep can be sudden.

If two doses are used, they need to be taken between 2.5 and 4 hours apart. Patients should keep their second dose on their night table and might need to set an alarm to make sure that they wake up to take it on time.

What This Means For You

Accessibility and Limitations of Xywav

Oxybate has the potential for physical or psychological dependence; therefore, it is a Schedule III controlled substance.

Patients who abruptly stopped taking Xyrem—another prescription version of oxybate—have reported withdrawal. Symptoms of withdrawal can include, insomnia, anxiety, psychosis, confusion, and more.

Xywav carries the potential for abuse. Since it causes central nervous system depression, the FDA is requiring that it be prescribed and dispensed through a Risk Evaluation and Mitigation Strategy program (REMS).

Known Side Effects

In theclinical trialfor the drug:

Some people taking Xywav have also reported sleep-related side effects, such as abnormal dreams, sleep terrors, sleep talking, sleepwalking, sleep talking, and abnormal dreams, sleep paralysis, and sleep talking.

Xywav can also have more serious side effects like:

Xywav depresses the centralnervous system. It has the potential to slow breathing rate and lower blood pressure—possibly to dangerously low levels. Therefore, Xywav should not be taken with alcohol or any drugs that also depress the central nervous system, such as antidepressants, antipsychotics, benzodiazepines, or opioids.

Getting Xywav to Treat Your Idiopathic Hypersomnia

Oxybate can cause physical dependence. It is also a drug that can be abused, which means that there are special requirements for Xywav prescriptions.

If you think that you might have idiopathic hypersomnia, ask your doctor for a referral to a sleep specialist. They might ask you tokeep a sleep diaryand have an overnight test in a sleep laboratory.

How Sleep Disorders Are Diagnosed

9 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration (FDA).FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment.Jazz Pharmaceuticals.Xywav FAQs.U.S. Department of Justice. Drug Enforcement Administration.Gamma hydroxybutyric acid.Jazz Pharmaceuticals.Transitioning from Xyrem.Jazz Pharmaceuticals.How to Prepare and Take Xywav.Food and Drug Administration (FDA).XYWAV: Highlights of Prescribing Information.Jazz Pharmaceuticals.Xywav Medication Guide.Jazz Pharmaceuticals.Xywav.Jazz Pharmaceuticals.How to Get Xywav.

9 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration (FDA).FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment.Jazz Pharmaceuticals.Xywav FAQs.U.S. Department of Justice. Drug Enforcement Administration.Gamma hydroxybutyric acid.Jazz Pharmaceuticals.Transitioning from Xyrem.Jazz Pharmaceuticals.How to Prepare and Take Xywav.Food and Drug Administration (FDA).XYWAV: Highlights of Prescribing Information.Jazz Pharmaceuticals.Xywav Medication Guide.Jazz Pharmaceuticals.Xywav.Jazz Pharmaceuticals.How to Get Xywav.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration (FDA).FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment.Jazz Pharmaceuticals.Xywav FAQs.U.S. Department of Justice. Drug Enforcement Administration.Gamma hydroxybutyric acid.Jazz Pharmaceuticals.Transitioning from Xyrem.Jazz Pharmaceuticals.How to Prepare and Take Xywav.Food and Drug Administration (FDA).XYWAV: Highlights of Prescribing Information.Jazz Pharmaceuticals.Xywav Medication Guide.Jazz Pharmaceuticals.Xywav.Jazz Pharmaceuticals.How to Get Xywav.

Food and Drug Administration (FDA).FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment.

Jazz Pharmaceuticals.Xywav FAQs.

U.S. Department of Justice. Drug Enforcement Administration.Gamma hydroxybutyric acid.

Jazz Pharmaceuticals.Transitioning from Xyrem.

Jazz Pharmaceuticals.How to Prepare and Take Xywav.

Food and Drug Administration (FDA).XYWAV: Highlights of Prescribing Information.

Jazz Pharmaceuticals.Xywav Medication Guide.

Jazz Pharmaceuticals.Xywav.

Jazz Pharmaceuticals.How to Get Xywav.

Meet Our Medical Expert Board

Share Feedback

Was this page helpful?Thanks for your feedback!What is your feedback?OtherHelpfulReport an ErrorSubmit

Was this page helpful?

Thanks for your feedback!

What is your feedback?OtherHelpfulReport an ErrorSubmit

What is your feedback?