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XYWAV® Narcolepsy Homepage

ABOUT NARCOLEPSY

Narcolepsy is a chronic,
potentially disabling, condition

There are 2 types of narcolepsy:
narcolepsy type 1 and type 2.

Both types are characterized by the symptom of excessive daytime sleepiness (EDS)

Everyone with narcolepsy has EDS as a symptom.
  • The uncontrollable need to sleep during the day
  • Sleep episodes can come on randomly and at unusual or unexpected times
  • Most likely to happen in situations that don’t require active participation, such as when you are watching TV or reading a book
  • Can also occur when it is important to be alert, such as during conversations, eating, walking, or at work

People with narcolepsy type 1 also have cataplexy, which is a brief loss of muscle control that can happen when you feel a strong emotion

About 70% of people with narcolepsy are believed to have cataplexy as a symptom.
  • Attacks can be fairly mild—such as a sagging jaw, drooping eyelid, head drop, slurred speech, weakness in the arm or shoulder, or slightly buckling knees
  • In severe cases, people can fall or sink to the ground, even though they are awake and aware of their surroundings
  • In children, cataplexy may be most noticeable by unusual movements in the face, such as eyelids drooping, eyes closing, grimacing, mouth movements, or tongue sticking out
  • Cataplexy attacks usually last from a few seconds to a couple of minutes

Learning about narcolepsy

Since there is no cure for narcolepsy, management for symptoms, such as EDS and cataplexy, may be needed.

  • EDS is the uncontrollable need to sleep during the day. Everyone with narcolepsy has EDS
  • Cataplexy is a common symptom of narcolepsy and can be described as when your muscles suddenly become weak or go limp when you feel a strong emotion. About 70% of people with narcolepsy are believed to have cataplexy
Living with Narcolepsy

XYWAV helps treat the symptoms of cataplexy and EDS

XYWAV is approved by the Food and Drug Administration (FDA) to treat cataplexy and/or EDS in people ages 7 years and older with narcolepsy. In a clinical study, XYWAV, taken at night, has been shown to improve cataplexy and/or EDS in adults with narcolepsy during the day.

What is XYWAV

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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