What is XYWAV?
XYWAV is the first and only lower-sodium oxybate approved by the FDA to treat cataplexy or excessive daytime sleepiness in people 7 years and older with narcolepsy.
How is XYWAV different from XYREM® (sodium oxybate) oral solution?
XYWAV has the same amount of oxybate as sodium oxybate, with 92% less sodium in each nightly dose.
Can I change from XYREM treatment to XYWAV?
Your doctor can help determine whether XYWAV is right for you. Talk to your doctor about an appropriate treatment plan.
Why did Jazz Pharmaceuticals make XYWAV?
XYREM contains a lot of sodium, with 1640 mg per day at the maximum recommended nightly dose for adults. XYWAV, with 131 mg of sodium per maximum recommended total nightly dose for adults, was developed to provide a lower-sodium oxybate option.
How do I take XYWAV?
If your doctor prescribes you XYWAV, he or she will give you detailed instructions on how to take your nightly doses. You will also receive additional materials to ensure that you understand how to mix and take your nightly XYWAV doses. Learn more about dosing.
What are the possible side effects of XYWAV?
The most common side effects in adult patients treated with XYWAV in the clinical trial included headache, nausea, dizziness, decreased appetite, 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, sleep walking, and other abnormal sleep-related events), diarrhea, excessive sweating (hyperhidrosis), anxiety, and vomiting. In patients who remained on treatment, side effects tended to occur early and diminish over time.
In children, the most common side effects include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.
These are not all the possible side effects of XYWAV. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
How much does XYWAV cost?
Jazz Pharmaceuticals is committed to making sure that people who are prescribed XYWAV can get it affordably.
What support is available if my doctor prescribes XYWAV?
Jazz Pharmaceuticals, the leader in sleep medicine, is committed to helping you get therapy support and assistance throughout your treatment journey based on your personal needs every step of the way.
- Nurse and pharmacy support—Your JazzCares® Nurse Case Manager will be with you from the very beginning in your treatment journey, and a pharmacist is available 24/7 to answer questions about your prescription
- Access and affordability—The Certified Pharmacy will assist you with navigating the insurance process and understanding your insurance coverage to help get your treatment started
- Personalized resources—At different points along the way, you will receive relevant tools and resources to help as you start and continue your therapy, including:
- myWAV, the 24/7 digital tool for personalized support and motivation
- A Starter Kit to help you get started on your path to your first shipment of XYWAV
- A Welcome Kit with everything you need to manage your XYWAV treatment
- Prescription refill reminders
- Tools and resources to help you consider your overall health when managing your narcolepsy
- Information and support resources for caregivers and loved ones
Why can’t I get XYWAV at my local pharmacy?
Because of the risk of CNS depression, abuse, and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS. You or your child must be enrolled in this program to receive XYWAV.
In addition, the Certified Pharmacy is the only pharmacy in the United States that is permitted to fill your XYWAV prescription and send it directly to you.
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)
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 Program 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. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.
The most common side effects of XYWAV in adults include headache, nausea, dizziness, decreased appetite, 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, sleep walking, and other abnormal sleep-related events), diarrhea, excessive sweating (hyperhidrosis), anxiety and vomiting.
The most common side effects of 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.