Learning how to prepare and take XYWAV
Follow the instructions for proper preparation and dosing
When you receive your first shipment of XYWAV, you’ll receive the Patient Quick Start Guide along with your medication and detailed preparation and dosing instructions. Here’s an overview of what you’ll need to know to take XYWAV:
- XYWAV is taken at night divided into 2 doses
- Prepare your 2 doses at the same time, prior to bedtime, and put them in a safe and secure place. Before you take or give XYWAV, each dose should be mixed with approximately ¼ cup of water in the empty pharmacy containers included in the first shipment
- Take your first dose while in bed and lie down immediately
- XYWAV can cause sleep very quickly without feeling drowsy. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes
- Take the second dose 2½ to 4 hours later, as instructed by your doctor, while in bed and lie down immediately after dosing. You should remain in bed after taking each dose of XYWAV
- Prepared doses should be taken within 24 hours after mixing
- If you miss the second dose, skip it
- Never take 2 doses of XYWAV at one time
- Wait at least 2 hours after eating before taking XYWAV
- Store XYWAV in a safe place, away from children and pets
- For children, give the first XYWAV dose at bedtime or after an initial period of sleep, while your child is in bed and have them lie down immediately. Give the second XYWAV dose 2½ to 4 hours after the first XYWAV dose. You may want to set an alarm clock to make sure you wake up to give the second XYWAV dose. Your child should remain in bed after taking the first and second doses of XYWAV
XYWAV Medication Guide
Read the Instructions for Use in the Medication Guide for detailed instructions on preparing and taking XYWAV.
This Medication Guide helps you with preparing and taking 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.