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Prescribing InformationMedication Guide
Important Safety Information

For Healthcare
Providers
Prescribing Information
Medication Guide
Important Safety Information

For Healthcare Providers



DISCOVER XYWAV


DISCOVER XYWAV


FOR NARCOLEPSY

XYWAV can help treat cataplexy and/or excessive daytime sleepiness (EDS).


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FOR IDIOPATHIC HYPERSOMNIA (IH)

XYWAV is the first and only FDA-approved treatment for adults with IH.


LEARN MORE

XYWAV oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)
is the only FDA‑approved treatment for cataplexy and/or excessive daytime
sleepiness in narcolepsy and for idiopathic hypersomnia (IH) in adults.

XYWAV oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)
is the only
FDA‑approved treatment for cataplexy and/or excessive daytime sleepiness in
narcolepsy and for 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.

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.

 * Prescribing Information
 * Medication Guide
 * Important Safety Information

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