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What is XYWAV?

XYWAV is the only FDA-approved treatment for adults with Idiopathic Hypersomnia (IH)

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  • Why consider XYWAV?
  • How was XYWAV studied?
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Why consider XYWAV?

Here are some reasons why you may consider XYWAV to treat your Idiopathic Hypersomnia.

  1. First and only: XYWAV is the first treatment of its kind to be approved by the FDA for Idiopathic Hypersomnia.
  2. Taken at night: XYWAV is different—it's a prescription medicine taken at night to help treat multiple symptoms of Idiopathic Hypersomnia, such as excessive daytime sleepiness, sleep inertia (severe grogginess or confusion when waking up), long sleep time, and cognitive impairment.
  3. Individualized dosing: Your doctor will help find the best dose for you with twice- and once-nightly options.
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Patient Casey sharing how XYWAV® helped her IH symptoms

When I was first diagnosed with Idiopathic Hypersomnia, my treatment plan focused on excessive daytime sleepiness, but I also needed help managing my other IH symptoms. That's when my doctor told me about twice-nightly XYWAV.”

Casey

XYWAV IH Ambassador

Learn about taking XYWAV

Real patient compensated for their time. Individual results may vary.

XYWAV was studied across several aspects of Idiopathic Hypersomnia:

Excessive daytime sleepiness icon
Excessive daytime sleepiness, the most common symptom of Idiopathic Hypersomnia.
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Severity of Idiopathic Hypersomnia symptoms, including:
  • Sleep inertia (severe grogginess or confusion when waking up)
  • Long sleep time
  • Cognitive impairment

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Patient Diana shares her XYWAV® story

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Diana, a real patient and XYWAV IH Ambassador, shares her XYWAV story.

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other XYWAV IH Ambassadors

How was XYWAV studied?

  • The efficacy and safety of XYWAV was studied in 115 people aged 19-75 with Idiopathic Hypersomnia.
  • All people in the clinical study started treatment with XYWAV. Some participants continued taking their stimulant or wake‑promoting agent along with XYWAV.
  • XYWAV was adjusted to a stable dose (the dose that worked best for each person). Then they were randomly assigned to:
    • Continue treatment with XYWAV.
    • or
    • Stop taking XYWAV for 2 weeks. These people were switched to a placebo, a treatment that is inactive. This was to see if there was a difference in their symptoms.
Efficacy and safety study graph

This study was double-blinded. That means neither the investigators who ran the study nor the people in the study knew who got XYWAV or who got placebo during the period of the study that measured how well XYWAV worked.

*Not everyone completed the 10- to 14-week portion of the study

See study results

How does XYWAV work?

Although the exact way XYWAV works is unknown, it is thought to work during sleep to help with daytime symptoms.

Live & on-demand webinars

Check out our webinar series presented by experts in Idiopathic Hypersomnia and treatment with XYWAV. Programs cover a variety of topics and even include a live Q&A!

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Want to know more?

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XYWAV® (calcium, magnesium, potassium, and sodium oxybates) oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) is a prescription medicine used to treat:

  • the following symptoms in people 7 years of age or older with narcolepsy:
    • sudden onset of weak or paralyzed muscles (cataplexy)
    • excessive daytime sleepiness (EDS)
  • idiopathic hypersomnia (IH) in adults.

Important Safety Information

WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

The active ingredient of XYWAV is a form of gamma-hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you or your child has any of these serious side effects.

Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child's prescription for XYWAV filled.

Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.

Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.

XYWAV can cause serious side effects, including the following:

  • Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
  • Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
  • Sleepwalking. XYWAV can cause sleepwalking, which can cause injuries. Call your doctor if this occurs.

The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleepwalking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.

The most common side effects of XYREM (which also contains oxybate like XYWAV) in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.

XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.

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.

Please see full Prescribing Information, including BOXED Warning, and Medication Guide.

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