SODIUM IN XYWAV

XYWAV is the first and only low‑sodium* oxybate

^*XYWAV contains 131 mg of sodium at the maximum recommended nightly dose.

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A woman discussing her sodium intake and her narcolepsy symptoms

If you’re considering an oxybate—either with stimulants or on its own—talk to your doctor about the high-sodium elephant in the room.

Ask about XYWAV, the only low-sodium option.

XYWAV has ~1509 mg less sodium per maximum recommended nightly dose than high-sodium oxybates

A bar graph comparing the sodium content of 9-g dose of XYREM/LUMRYZ (~1640 mg), 9-g dose of XYWAV (131 mg), and 4 large orders of fries (~1520 mg)

^†XYREM and LUMRYZ contain ~1,640 mg of sodium at the maximum recommended 9-g nightly dose.

^‡Based on an average of 380 mg of sodium in 1 large serving of French fries according to a 2012 USDA analysis of 3 fast-food chains.

^§XYWAV contains 131 mg of sodium at the maximum recommended 9-g nightly dose.

If you choose a high-sodium oxybate, such as XYREM^® (sodium oxybate) oral solution or LUMRYZ^™ (sodium oxybate) extended-release for oral suspension, you may go over the ideal daily sodium intake recommended by the American Heart Association without eating or drinking anything.

Transitioning from XYREM

Only XYWAV is clinically superior to XYREM, a high‑sodium oxybate, based on safety^‖

XYWAV has ~1509 mg less sodium per night than XYREM at the maximum 9‑g nightly dose^¶

Due to the reduction in sodium, the FDA determined XYWAV is clinically superior to XYREM by means of cardiovascular safety^‖

According to the FDA the differences in sodium content between XYWAV and XYREM at recommended doses will be clinically meaningful in reducing cardiovascular diseases for many people with narcolepsy who suffer from cataplexy and/or EDS^‖

Choosing XYWAV over high‑sodium oxybates, including the once‑nightly high‑sodium oxybate, reduces chronic sodium burden, which makes it the safer option.

A clinical trial comparing the efficacy and safety of XYWAV and LUMRYZ has not been conducted.

^‖The decision of the FDA Office of Orphan Product Development (OOPD) is based on findings that XYWAV provides a greatly reduced chronic sodium burden compared to XYREM. There are no head-to-head data for XYWAV and XYREM.

^¶XYWAV has 131 mg of sodium per maximum recommended 9-g nightly dose, while the equivalent dose of high-sodium oxybate XYREM contains ~1640 mg—a difference of ~1509 mg every single day.

Wondering if an oxybate treatment like low-sodium XYWAV might be right for you?

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IMPORTANT SAFETY INFORMATION

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.

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If you’re considering an .css-1bmnxg7{white-space:nowrap;}oxybate—either with stimulants or on its own—talk to your doctor about the high-sodium elephant in the room.

Ask about XYWAV, the only low-sodium option.

XYWAV has ~1509 mg less sodium per maximum recommended nightly dose than high-sodium oxybates

Wondering if an oxybate treatment like low-sodium XYWAV might be right for you?

XYWAV is the first and only low‑sodium* oxybate

If you’re considering an oxybate—either with stimulants or on its own—talk to your doctor about the high-sodium elephant in the room.