Xyrem (sodium oxybate) is a brand-name oral solution. It’s used to treat narcolepsy in adults and some children. As with other drugs, Xyrem can cause side effects. These include nausea, vomiting, and dizziness.

Xyrem is prescribed to treat cataplexy or excessive daytime sleepiness in adults and children ages 7 years and older with narcolepsy.

Xyrem belongs to a drug class called central nervous system depressants. The drug is not available in a generic version.

Read on to learn about potential common, mild, and serious side effects of Xyrem. For a general overview of the drug, including details about its uses, see this article.

Xyrem 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 Xyrem in clinical trials:

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

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

Mild side effects that have been reported with Xyrem include:

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 Xyrem and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Xyrem. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

Xyrem may cause serious side effects. Though serious side effects aren’t common, they can occur. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Xyrem’s prescribing information.

If you develop serious side effects while taking Xyrem, 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:

* Xyrem has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.
Xyrem has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Xyrem and misuse” section below.
‡ An allergic reaction is possible after taking Xyrem. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

Xyrem can be prescribed for narcolepsy in children ages 7 years and older. Though many of the side effects of Xyrem are the same in adults and children, the most common side effects reported in children include:

If you have concerns about side effects that your child may experience while taking Xyrem, talk with your child’s doctor.

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

Does Xyrem cause long-term side effects?

Yes, it’s possible for Xyrem to cause long-term side effects. However, these side effects are rare.

Most side effects of Xyrem are short term. They may improve as you continue taking Xyrem or go away once treatment ends.

However, it’s possible for Xyrem to cause changes in mental health, such as depression, confusion, or suicidal thoughts. These changes in mental health may continue even after you stop treatment with Xyrem.

If you have concerns about long-term side effects from taking Xyrem, talk with your doctor.

Is hair loss a side effect of Xyrem?

No, you shouldn’t experience hair loss from taking Xyrem. Hair loss wasn’t a side effect that people taking Xyrem reported in clinical trials.

However, hair loss is a possible side effect of other medications that may be prescribed to treat narcolepsy. This includes Adderall (amphetamine/dextroamphetamine) and certain other stimulant drugs.

If you’re taking Xyrem and have concerns about hair loss during treatment, talk with your doctor.

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

Risk of central nervous system depression

It’s possible for Xyrem to cause central nervous system (CNS) depression. In fact, Xyrem has a boxed warning for this risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The purpose of a boxed warning is to alert healthcare professionals and people receiving treatment about the risks of taking a medication.

CNS depression refers to a slowing of brain activity and body functions controlled by your brain and spinal cord. In some cases, this condition may be life threatening.

Symptoms of CNS depression may be mild or serious and include:

What you can do

Due to the risk of CNS depression, you should not take Xyrem with certain other CNS depressants. These include opioid drugs, benzodiazepines, and alcohol. Combining any of these with Xyrem can increase the risk of more severe CNS depression. In some cases, this can be life threatening.

If you need to take opioids or benzodiazepines for a short time, your doctor may lower your dose of Xyrem. Or they may pause treatment with Xyrem until you can stop taking the other medication. Be sure to tell your doctor about any medications that you take before starting Xyrem treatment. They can help make sure that Xyrem is safe for you.

It’s important to avoid driving a car or operating other machinery until you know how Xyrem may affect you. Your doctor will likely recommend avoiding activities that require your full attention for at least 6 hours after taking Xyrem. (Keep in mind that Xyrem doses are taken right before going to sleep.)

Due to the risk of CNS depression, Xyrem is only available through a risk evaluation mitigation strategy (REMS) program. Both doctors and those receiving treatment must be enrolled in this program. The purpose of the REMS program is to decrease the risk of serious side effects that may be caused by Xyrem.

For more information about this program and the risk of CNS depression, talk with your doctor or pharmacist.

Nausea

It’s possible to experience nausea from taking Xyrem. This was one of the most common side effects reported in Xyrem’s clinical trials. Nausea may become more severe at higher doses of the drug.

What you can do

If you experience persistent or bothersome nausea during treatment, talk with your doctor. They may prescribe a lower dose of Xyrem or suggest other ways to manage this symptom.

However, it’s important to talk with your doctor before making any adjustments to your dosage. Always follow the dosage your doctor prescribes for you.

Dry mouth

Xyrem can cause dry mouth in certain people. However, in clinical trials, this side effect wasn’t common.

What you can do

If you experience persistent or bothersome dry mouth during treatment, talk with your doctor or pharmacist. They can help determine the cause of this side effect and recommend ways to manage it. For example, they may recommend certain over-the-counter mouthwashes or lozenges for dry mouth.

Allergic reaction

As with most drugs, Xyrem can cause an allergic reaction in some people. It’s not clear whether this side effect occurred in clinical trials. However, they’ve been reported since Xyrem was approved for use.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Xyrem. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

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.

Tell your doctor about any medical conditions that you have or any medications that you take before starting treatment with Xyrem. They’ll help make sure that Xyrem is a safe treatment option for you.

Boxed warnings

This drug has boxed warnings about the risk of central nervous system (CNS) depressionand the risk of misuse. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). For details on CNS depression, see the “Side effect specifics” section above. For more information on misuse, see the “Xyrem and misuse” section below.

Other precautions

Be sure to talk with your doctor about your health history before you take Xyrem. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Lung conditions. Before you start taking Xyrem, tell your doctor about any breathing problems you may have. This drug may slow down your breathing. If you already have a lung condition, such as asthma, taking Xyrem may make it worse. In this case, your doctor can help determine whether Xyrem is safe for you.

Sleep apnea. Xyrem may slow down your breathing. If you have sleep apnea, you may already have difficulty breathing while sleeping. Xyrem can make this condition worse. If you have sleep apnea, talk with your doctor to determine whether Xyrem may be safe for you.

High blood pressure. If you have high blood pressure, tell your doctor before taking Xyrem. This medication contains a high amount of sodium, which can increase blood pressure. If you have high blood pressure, taking Xyrem may make this condition worse. Your doctor will determine whether Xyrem is safe for you to take. They may advise considering Xyrem as part of your daily sodium intake.

Allergic reaction. If you’ve had an allergic reaction to Xyrem or any of its ingredients, your doctor will likely not prescribe Xyrem. Ask your doctor about other medications that may be better options for you.

Mood disorders. If you have any mood disorders, such as depression or anxiety, tell your doctor before starting treatment with Xyrem. Xyrem can cause mood changes. If you have a mood disorder, taking Xyrem may make your condition worse. Your doctor can advise whether Xyrem is the safest treatment option for you.

Liver problems. Tell your doctor about any liver problems that you have before taking Xyrem. If you have a liver condition, your body may not break down Xyrem as quickly as it should. This can cause the medication to build up in your body, which increases your risk of side effects. In some cases, your doctor may recommend a lower dose of Xyrem.

Kidney problems. Before taking Xyrem,tell your doctor about any kidney problems you may have. This medication contains a high amount of sodium. If you have kidney problems, taking Xyrem may make your condition worse. Your doctor can help determine whether this medication is safe for you to take.

Heart failure. If you have heart failure, tell your doctor before you start taking Xyrem. This medication contains a high amount of sodium. If you have heart failure, taking Xyrem may make your condition worse. Your doctor can help determine whether Xyrem may be safe for you.

Succinic semialdehyde dehydrogenase deficiency. It is contraindicated to take Xyrem if you have a rare brain disorder called succinic semialdehyde dehydrogenase deficiency. (A contraindication is a factor or condition that could prevent your doctor from prescribing a drug due to the risk of harm.) This condition can cause Xyrem to build up in your body, which increases your risk of serious side effects. Your doctor can discuss safer treatment options for you.

Alcohol with Xyrem

You should not take Xyrem with alcohol.

Both Xyrem and alcohol can cause CNS depression. This may cause difficulty breathing, low blood pressure, or fainting. Drinking alcohol during treatment with Xyrem may increase your risk of this side effect. In some cases, CNS depression can be life threatening.

If you drink alcohol and have questions about drinking it while taking Xyrem, talk with your doctor or pharmacist.

Pregnancy and breastfeeding while taking Xyrem

It’s not known whether Xyrem is safe to take during pregnancy or while breastfeeding.

There currently aren’t enough clinical trials to determine whether Xyrem may be safe to take during pregnancy. It’s also not known what effects the drug may have on a developing fetus.

In animal studies, there was an increased risk of pregnancy loss when Xyrem was given during pregnancy. In addition, animals given Xyrem during pregnancy had offspring with slower-than-usual growth. However, it’s important to note that animal studies don’t always indicate what may happen in humans.

In clinical trials, Xyrem passed into human breast milk. However, it’s not known what effects Xyrem may have on a child who is breastfed.

If you’re pregnant, breastfeeding, or planning for either, talk with your doctor before taking Xyrem.

Xyrem has a boxed warning for the risk of misuse. A boxed warning is the most serious warning recommended by the Food and Drug Administration (FDA). The purpose of a boxed warning is to alert patients and prescribers about the risks of taking a medication.

Misuse of a drug means taking it in a way that’s different than how it was prescribed. This may be more likely to occur if a person develops a dependence on Xyrem. With dependence, your body needs the drug to feel like it usually does. You can develop a dependence while taking a drug exactly as prescribed. However, it’s possible for dependence to lead to misuse.

If you take Xyrem long term, you may develop a tolerance to the drug. With drug tolerance, your body needs higher doses of a medication to achieve the desired effect. This may increase the risk of misuse. For this reason, it’s important to take Xyrem exactly as prescribed. Do not increase your dose without first talking with your doctor.

Xyrem misuse may cause serious side effects, such as severe central nervous system (CNS) depression. In fact, the drug has a boxed warning for this side effect. For more details, see the “Side effect specifics” section.

If you have a higher risk of misuse, including a history of substance use disorder, talk with your doctor. They can decide whether Xyrem is safe for you to take.

Due to the risk of misuse, Xyrem is only available through a risk evaluation mitigation strategy (REMS) program. The drug is only available to doctors and those receiving treatment who are enrolled in this program. The purpose of the REMS program is to decrease the risk of serious side effects that may be caused by Xyrem.

For more information about this program and the risk of misuse, talk with your doctor or pharmacist.

Side effects from Xyrem are usually mild. However, serious side effects can also occur from this medication.

If you’d like to learn more about Xyrem, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you might want to do some research on your own. These articles might help:

  • More information about Xyrem. For details about other aspects of Xyrem, refer to this article.
  • Cost. If you’d like to learn about Xyrem and cost, see this article.
  • Drug comparison. To learn how Xyrem compares with Xywav, read this article.
  • Interactions. To find out about Xyrem’s interactions, see this article.
  • A look at narcolepsy. For details about narcolepsy, see our science of sleep hub.

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.