Possible Side Effects

Understanding the possible side effects of XYWAV

XYWAV can cause serious side effects that your doctor
will review with you carefully, 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
Difficulty concentrating

Tell your doctor if you have or had depression or have tried to harm yourself.Call your doctor right away if you have 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 in the XYWAV for IH clinical study included:

Nausea
Headache
Anxiety
Dizziness
Insomnia
Excessive sweating (hyperhidrosis)
Decreased appetite

Vomiting
Dry mouth
Diarrhea
Fatigue
Sleepiness (somnolence)
Tremor
Parasomnia

17 out of 154 people (11%) had side effects that made them stop taking XYWAV. Anxiety was the most common reason.

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. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

In clinical study participants who remained on treatment, side effects tended to occur early and diminish over time.

The possible side effects of XYWAV were seen in 2 clinical studies of more than 350 people living with IH or narcolepsy (aged 18 to 75).

What you should know about taking XYWAV with other medications:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially, tell your doctor if you take other medicines to help you sleep (sedatives).

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

If there are other medications you are currently taking, be sure to ask your doctor or pharmacist if XYWAV will interact or interfere with how they will work.

Talk to your doctorIf you're managing your IH with workarounds but still living with symptoms, it may be time to talk to a specialist about XYWAV or find a provider that can determine if XYWAV is right for you.

Tips for doctor discussion

Get information and stay supported

From learning more about your IH, to helping start the conversation with your doctor, and exploring XYWAV as a treatment option—take charge of your journey with support every step of the way.

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.