Uses
What is Xywav used for?
Xywav (calcium/magnesium/potassium/sodium oxybates) is commonly used for the following conditions.
- Narcolepsy, which includes cataplexy and excessive daytime sleepiness (EDS)
- A sleep disorder called idiopathic hypersomnia
Xywav may also be used for other conditions as determined by your healthcare provider.
How does Xywav work (mechanism of action)?
Xywav works by binding to certain receptors in the brain called GABA receptors. By binding to these receptors while you are sleeping, Xywav changes the way that the brain responds to sleep.
How is Xywav supplied (dosage forms)?
Xywav is available as a 0.5 g/mL oral solution that is taken by mouth.
How should I store Xywav?
Xywav should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in the original bottle in a cool, dry place.
Once a dose of Xywav has been mixed with water, it must be used within 24 hours. If it is not used within 24 hours, it should be poured down the sink drain.
Side Effects
What are the most common side effects of Xywav?
The most common side effects of Xywav are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Anxiety
- Bedwetting
- Decreased appetite
- Diarrhea
- Dizziness
- Drowsiness
- Dry mouth
- Headache
- Insomnia
- Issues while sleeping, called parasomnias (see below)
- Nausea and vomiting
- Sweating more than usual
- Tremor
- Weight loss (in children)
There may be other side effects of Xywav that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Xywav?
While less common, the most serious side effects of Xywav are described below, along with what to do if they happen.
Severe Allergic Reactions. Xywav may cause allergic reactions, which can be serious. Stop taking Xywav and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Behavior Changes. Xywav may cause behavior changes in a small number of people. Tell your healthcare provider right away if you have any of the following symptoms.
- Aggressive behavior
- Confusion
- Disconnecting from reality (psychosis)
- Seeing or hearing things that others do not see or hear, also called hallucinations
- Other changes in behavior or mood
Breathing Problems. Xywav may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your healthcare provider if you develop severe sleepiness or trouble breathing, especially when you start Xywav or when your dose is increased. Get emergency help if you have any of the following symptoms.
- Changes in the color of your skin, including bluish color to your lips and fingernails
- Confusion
- Shortness of breath
- Feeling dizzy, lightheaded, or fainting
- Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat
- Slow or shallow breathing
- Excessive sleepiness or trouble staying awake
Central Nervous System (CNS) Depression. Xywav may slow down your central nervous system (CNS), which controls many vital functions throughout the body. Call your healthcare provider right away if you have any of the following symptoms of CNS depression.
- Confusion
- Excessive sleepiness or trouble staying awake
- Memory problems
- Slow or shallow breathing
- Slowed response or reaction time
- Slurred speech
Sleep Disorders (Parasomnias). Xywav may cause parasomnias, which are sleep disorders that cause strange behaviors while sleeping. Let your healthcare provider know if you are experiencing any new issues or behaviors while sleeping. Some examples of parasomnias include the following.
- Bedwetting (enuresis)
- Night terrors that cause you to wake up
- Sleepwalking
Risk of Misuse and Addiction. Misusing Xywav can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take Xywav exactly as prescribed. Tell your healthcare provider if you feel that Xywav is not working. Call your healthcare provider right away or go to the nearest emergency room if you experience any of the following serious symptoms.
- Sudden confusion or feeling disoriented
- Feeling paranoid
- Suicidal thoughts or actions
- Seizures
- Trouble breathing
Suicidal Thoughts and Actions. Xywav may cause depression and/or suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
Warnings & Precautions
Who should not use Xywav?
Allergies to Ingredients. People who are allergic to any of the following should not take Xywav.
- Calcium oxybate
- Gamma-hydroxybutyrate
- GHB
- Magnesium oxybate
- Potassium oxybate
- Sodium oxybate
- Xywav
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Xywav.
A Rare Condition Called Succinic Semialdehyde Dehydrogenase Deficiency. Xywav should not be used by anyone with this condition. People with this condition are not able to break down Xywav in the body.
Alcohol Use. If you drink alcohol, you should not use Xywav. See the Interactions section for more details.
Drug Interactions. Xywav should not be taken while you are using certain other medicines. Before taking Xywav, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
What should I know about Xywav before using it?
Do not take Xywav unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Xywav with other people, even if they have the same condition as you. It may harm them.
Keep Xywav out of the reach of children. Xywav is a controlled substance because it can be misused or lead to dependence. Store Xywav in a safe place to protect it from theft. It is illegal to sell or give away this medicine.
Xywav is a liquid medicine. Use an accurate measuring device to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist to recommend an appropriate measuring device.
Xywav is mixed with water before use. You should receive instructions from your pharmacy on how to mix your medicine with water. Once a Xywav dose has been mixed, it must be taken within 24 hours. If it is not used within 24 hours, it should be poured down the sink drain.
Xywav can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination for at least 6 hours after taking Xywav, until you know how Xywav affects you.
If Xywav is misused, it can cause serious health issues and breathing problems. To reduce the risk of this happening, Xywav is only available through a restricted program. As part of this program, Xywav can only come from a specific certified pharmacy. This pharmacy can only ship the medicine to people who are enrolled in the restricted program.
Xywav should be taken right before going to sleep. It is best to take it while in bed, then to lay down and stay in bed for the night, since you may fall asleep without feeling sleepy first. Your healthcare provider may prescribe one or two doses of Xywav each night. If you are supposed to take a second dose, you may need to set an alarm to wake you up for that dose.
What should I tell my healthcare provider before using Xywav?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Xywav is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Breathing problems
- Depression
- Other mental health problems
- History of drug abuse
- History of suicide attempts
- Liver problems
- Sleep apnea
Pregnancy. It is not known if or how Xywav could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Xywav while you are pregnant or trying to get pregnant.
Breastfeeding. Xywav passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Xywav while breastfeeding.
How can I get more information about Xywav?
For more information about Xywav, you can visit the manufacturer’s website at www.xywav.com or call them at 866-997-3688.
Interactions
Does Xywav interact with foods or drinks?
Xywav should be taken on an empty stomach. Avoid taking Xywav within 2 hours after food.
Drinking alcohol when using Xywav can cause serious health issues, including breathing problems, heart problems, severe drowsiness, and even death. If you are using Xywav, you should not drink alcohol.
Does Xywav interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Xywav.
- An antidepressant, which is a medicine used to treat depression
- An antipsychotic, which is a medicine for certain mental health conditions
- A barbiturate, such as phenobarbital, butalbital, or primidone, which is a medicine that may be used to treat insomnia, migraines, or seizures
- A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
- A medicine to relax the muscles
- A sedative, such as zolpidem (Ambien and others), zaleplon (Sonata), eszopiclone (Lunesta), or any other medicine used to help you sleep
- An opioid, such as oxycodone, morphine, codeine, or fentanyl, which is a medicine used for certain types of pain
- Divalproex (Depakote), which is a medicine used to control seizures
- Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, certain medicines to treat seizures, and medicines for anxiety
This may not be a complete list of medicines that can interact with Xywav. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Xywav?
If you or someone else has used too much Xywav, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Xywav?
If a dose is missed, skip the missed dose and only take the next dose. Do not take double or extra doses.
Are you currently using Xywav (calcium/magnesium/potassium/sodium oxybates)?
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