Xywav can cause severe drowsiness and can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines. You should not do anything that requires you 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 is a federal controlled substance (CIII). The active ingredient of Xywav is a form of gammahydroxybutyrate (GHB) that is also a federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants, may cause serious medical problems.
Fatal side effects can occur if you take Xywav with: alcohol, other sleep medicines, or other drugs that cause drowsiness or slow your breathing.
Misuse of Xywav can cause breathing problems, seizure, loss of consciousness, or death. Keep the medication in a place where others cannot get to it.
Before taking this medicine
Do not drink alcohol or take other sleep medicines together with Xywav. Dangerous side effects or death could occur.
Do not give Xywav to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
To make sure Xywav is safe for you, tell your doctor if you have ever had::
breathing problems;
snoring, or sleep apnea (breathing stops during sleep);
depression or suicidal thoughts;
psychosis or unusual behaviors (anxiety, agitation, paranoia, aggression, hallucinations);
liver disease; or
a drug addiction.
Tell your doctor if you are pregnant or breastfeeding.
Xywav is not approved for use by anyone younger than 7 years old.
How should I take this medicine?
Take Xywav exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Xywav can cause severe drowsiness and can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine.
Xywav may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law. Do not allow anyone else to use this medicine.
Take Xywav at least 2 hours after a meal.
Xywav is usually taken in 2 doses, once at bedtime and again 2.5 to 4 hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Lie down right away after taking the medicine.
Prepare both doses while you are getting ready for bed. Place the second dose in a secure location next to your bed so you can take it without getting up. You may need to set an alarm to awaken for the second dose.
Each dose of Xywav must be mixed with 2 ounces (1/4 cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any Xywav dose that has been mixed with water but not used within 24 hours of mixing.
Do not allow a child to use this medicine without adult supervision.
Do not change your dose or stop using Xywav suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat.
Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover Xywav liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, pour any unused liquid medicine down a sink drain.
