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Prescribing
Information
Medication
Guide
Important Safety
Information


XYREM HQ has come to an end, but not our commitment to supporting your treatment
journey.
Looking for additional information about or support for XYREM?
Visit us here
Learn about another treatment option to help treat two key symptoms of
narcolepsy. Go


APPROVED USE

XYREM® (sodium oxybate) oral solution, 0.5 g/mL 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 XYREM 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 XYREM is a form of gamma hydroxybutyrate (GHB). Abuse
or misuse of illegal GHB alone or with other CNS depressants (drugs that cause
changes in alertness or consciousness) have 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. You or
your child must be enrolled in the XYWAV and XYREM REMS to receive XYREM.

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

Keep XYREM in a safe place to prevent abuse and misuse. Selling or giving away
XYREM 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 XYREM 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 XYREM. Those activities should
not be done until you know how XYREM affects you or your child.

Falling asleep quickly, including while standing or while getting up from the
bed, has led to falls with injuries that have required some people to be
hospitalized.

XYREM 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 take XYREM.
 * 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, and 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.

Tell your doctor if you are or your child is on a salt-restricted diet or if you
have or your child has high blood pressure, heart failure, or kidney problems.
XYREM contains a lot of sodium (salt) and may not be right for you or your
child.

The most common side effects of XYREM in adults include nausea, sleepiness,
dizziness, vomiting, bedwetting, and tremor. The most common side effects of
XYREM in children include, nausea, bedwetting, vomiting, headache, weight
decreased, decreased appetite, dizziness and sleepwalking. Your side effects may
increase when you take higher doses of XYREM. XYREM 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 XYREM.

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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| This site is intended for U.S. residents only.
US-XYR-2100007 Rev0621
Important Safety InformationWARNING: Taking XYREM 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 XYREM is a form of gamma hydroxybutyrate (GHB). Abuse
or misuse of illegal GHB alone or with other CNS depressants (drugs that cause
changes in alertness or consciousness) have 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. You or
your child must be enrolled in the XYWAV and XYREM REMS to receive XYREM.