Xywav (calcium, magnesium, potassium, and sodium oxybates) is a brand-name medication that’s prescribed for certain sleep disorders in adults and some children. Xywav can cause mild or serious side effects, such as nausea or headache.

Xywav has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.

Xywav can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Xywav in clinical trials:

  • headache
  • dizziness
  • nausea or vomiting
  • diarrhea
  • dry mouth

Mild side effects can occur with Xywav use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Xywav’s prescribing information.

Mild side effects that have been reported with Xywav include:

  • headache
  • dizziness
  • nausea or vomiting
  • diarrhea
  • dry mouth
  • decreased appetite
  • fatigue
  • sleepiness
  • increased sweating
  • tremors

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Xywav and want to tell the FDA about it, visit MedWatch.

Xywav may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Xywav’s prescribing information.

If you develop serious side effects while taking Xywav, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • anxiety or confusion, which may include symptoms such as:
    • difficulty concentrating
    • forgetfulness
    • restlessness
    • uncontrollable feelings of worry
    • irritability
  • sleep disorders, such as sleep apnea, which may include symptoms such as:
    • loud snoring
    • gasping for air while sleeping
    • fatigue
    • waking up with a dry or sore throat
  • parasomnias (unusual behaviors or dreams during sleep), which may include symptoms such as:
    • abnormal dreams
  • central nervous system (CNS) depression*
  • risk of misuse*
  • mental health problems*

* For more information about this side effect, see “Side effect specifics.”

ALLERGIC REACTION

For some people, Xywav solution can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Xywav, your doctor may recommend taking a different medication instead.

Xywav may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do side effects of Xywav in children compare with side effects seen in adults?

Overall, the side effects of Xywav reported in clinical trials are similar in children and adults.

However, some side effects were seen more often in children than adults, such as bedwetting and weight loss.

If you have questions about how the side effects of Xywav compare in adults and children, talk with your doctor or pharmacist.

Is there a risk of misuse with Xywav?

Yes, there is a risk of misuse with Xywav. In fact, Xywav has a boxed warning due to the risk of misuse. Misuse is when a drug is used other than how a doctor prescribes it. This can lead to serious side effects, including death. To learn more about this risk, see the “Side effect specifics” section below.

If you have questions about the risk of misuse, talk with your doctor or pharmacist.

Learn more about some of the side effects that Xywav may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Xywav.

Central nervous system depression

Xywav has a boxed warning about the risk of central nervous system (CNS) depression. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous. CNS depression is a rare but serious side effect reported in Xywav’s clinical trials.

Xywav works by slowing down the activity of the central nervous system. This can affect your breathing and motor skills and impair your judgment. Some of the symptoms of CNS depression may include:

  • sleepiness
  • slowed breathing rate
  • disorientation
  • dizziness
  • slow reflexes
  • heart rate that is lower than usual

More serious side effects such as seizures, coma, or death are also possible.

The risk of CNS depression is higher if used with other drugs that cause CNS depression, such as opioid pain medications, benzodiazepines, or muscle relaxers. CNS depression is more likely to occur if the drug is misused (a drug used in a way other than prescribed) but has also been reported at the recommended dosage.

What you can do

Tell your doctor all of the medications you are taking before starting treatment with Xywav. Your doctor can determine whether Xywav is safe to take with your medications. They may recommend stopping or decreasing the dose of some medicines. Or they may recommend a treatment other than Xywav to treat your condition.

Because of the risk of CNS depression when taken with alcohol, cannabis or certain drugs called sedative-hypnotics, your doctor likely won’t prescribe Xywav if you drink alcohol or take certain medications, such as zolpidem (Ambien) or eszopiclone (Lunesta).

It’s recommended that you don’t drive, operate heavy machinery, or do any other activities that require you to be fully awake for at least 6 hours after taking Xywav.

Talk with your doctor if you have any questions about the risk of CNS depression while taking Xywav.

Risk of misuse

Xywav has a boxed warning about the risk of misuse. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous. Misuse refers to using the drug in a way other than prescribed by your doctor. Xywav is classified as a controlled substance by the FDA due to this risk.

The misuse of Xywav can lead to serious side effects, including seizures, trouble breathing, coma, or even death.

What you can do

Before starting treatment with Xywav, it’s important to talk with your doctor if you’ve had a history of substance use disorder. Also, be sure to take Xywav only as prescribed by your doctor. Your doctor will talk with you about the risks of treatment with Xywav and determine if it’s a safe treatment option for you.

Due to the risk of misuse, Xywav is only available under a restricted program by the FDA called the risk evaluation and mitigation strategy (REMS). The FDA requires certain medications to have a REMS to make sure the drug is used safely and to help manage the serious risks of the medication. Only certain doctors can prescribe Xywav, and you’ll have to get the medication through a special pharmacy.

Talk with your doctor if you have any questions or concerns about the risk of misuse during treatment with Xywav.

Mental health problems

Xywav can cause some people to experience depression or suicidal thoughts while taking the drug. Depression was a common side effect reported in clinical studies. On the other hand, thoughts of suicide were rarely reported.

Symptoms of depression may include:

  • loss of interest in hobbies or activities you used to enjoy
  • trouble concentrating
  • difficulty making decisions
  • changes in appetite
  • fatigue (decreased energy)
  • persistent depressed mood
  • thoughts of suicide or dying

What you can do

Having depression or a history of depression or suicidal thoughts may increase the chances of these side effects occurring. Tell your doctor if you have or have had a history of depression or suicidal thoughts before starting treatment with Xywav. They’ll likely want to monitor you more closely for symptoms of depression or suicidal thoughts while taking Xywav.

If you or your loved ones notice any symptoms of depression or suicidal thoughts or behaviors during treatment with Xywav, you should talk with your doctor right away. They can determine if Xywav is safe for you to continue taking. They may also recommend a different medication to treat your condition.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

Below is important information you should consider before taking Xywav.

Xywav has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

Other precautions

Before taking Xywav, discuss your health history with your doctor. Xywav may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.