Xywav is a brand-name oral solution prescribed for certain sleep disorders. Xywav contains the active ingredients calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. It belongs to the central nervous system depressant drug class.
Xywav is approved by the Food and Drug Administration (FDA) to treat the following sleep disorders:
- idiopathic hypersomnia in adults
- narcolepsy symptoms of excessive daytime sleepiness and cataplexy in adults and children ages 7 years and older
Drug details
You’ll find key information about Xywav below.
- Drug form: oral solution
- Generic available? no
- Prescription required? yes
- Controlled substance? yes
- Year of FDA approval: 2002
Xywav has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Xywav precautions” section.
Xywav is available only as a brand-name medication. It’s not currently available in a generic form.
A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.
The Xywav dose your doctor prescribes will depend on several factors. These include:
- the type and severity of the condition you’re using Xywav to treat
- your age
- other medical conditions you may have
- other medications you may be taking
- in children, body weight in kilograms (kg)*
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
* For reference, 1 kg is about 2.2 pounds (lb).
Drug form and strength
Xywav comes as an oral solution. It’s available in one strength of 0.5 grams (g) per milliliter (mL) of solution. Xywav comes in a 180-mL bottle.
Dosage for idiopathic hypersomnia
Doctors prescribe Xywav to treat idiopathic hypersomnia in adults. For this use, doctors may prescribe the drug in one or two nightly doses.
When prescribed as one nightly dose: The usual starting dosage of Xywav is 3 g (6 mL) or less, taken once each night. You’ll take the dose at bedtime.
When prescribed as two nightly doses: The usual starting dosage of Xywav is 4.5 g (9 mL) or less, divided into two doses each night. You’ll take the first dose at bedtime and the second dose 2.5 to 4 hours later. For example, you may take 2.25 g (4.5 mL) at bedtime followed by 2.25 g (4.5 mL) up to 4 hours later. Your doctor can tell you how much Xywav to take for each dose.
With either option, your doctor may increase your dosage by up to 1.5 g per night each week until you reach the maximum dosage. Your ongoing dosage will depend on how your condition responds to Xywav treatment.
The maximum recommended single dose of Xywav is 6 g (12 mL), while the maximum total nightly dose is 9 g (18 mL).
Your doctor may prescribe a different dosage depending on certain factors, including whether you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.
Dosage for certain narcolepsy symptoms
Doctors prescribe Xywav to treat narcolepsy symptoms of excessive daytime sleepiness and cataplexy in adults. For this use, doctors prescribe the drug in two nightly doses.
The usual starting dosage of Xywav is 4.5 g (9 mL) per night or less, divided into two doses. You’ll take the first dose at bedtime, and the second dose 2.5 to 4 hours later. For example, you may take 2.25 g (4.5 mL) at bedtime, followed by 2.25 g (4.5 mL) up to 4 hours later. Your doctor will tell you how much Xywav to take for each dose.
Your doctor may increase your dosage by up to 1.5 g per night each week. Your ongoing dosage will depend on how your condition responds to Xywav treatment. The maximum recommended nightly dose of Xywav is 9 g (18 mL).
Your doctor may prescribe a different dosage depending on certain factors, including whether you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.
Children’s dosage
Doctors prescribe Xywav to treat narcolepsy symptoms of excessive daytime sleepiness and cataplexy in children ages 7 years and older.
For this use, doctors prescribe the drug in two nightly doses. Your child will take the first dose at bedtime and the second dose 2.5 to 4 hours later.
For children weighing less than 20 kg (about 44 lb), their doctor will recommend the appropriate Xywav dosage to treat their condition.
The following table outlines the recommended dosage for children weighing 20 kg (about 44 lb) or more.
| Body weight in kg | Approximate body weight in lb | Usual starting dose | Maximum recommended nightly dose |
| 20 kg to less than 30 kg | 44 lb to less than 66 lb | up to 2 g, divided into two nightly doses | up to 6 g, divided into two nightly doses |
| 30 kg to less than 45 kg | 66 lb to less than 99 lb | up to 3 g, divided into two nightly doses | up to 7.5 g, divided into two nightly doses |
| 45 kg or more | 99 lb or more | up to 4.5 g, divided into two nightly doses | up to 9 g, divided into two nightly doses |
For example, a child weighing 35 kg (about 77 lb) may be prescribed 1.5 g (3 mL) at bedtime, followed by 1.5 g (3 mL) up to 4 hours later. Your child’s doctor will tell you how much Xywav to give your child for each dose.
Your child’s doctor may increase the dosage by up to 1.5 g per night each week, depending on your child’s weight. Your child’s ongoing dosage will depend on how their condition responds to Xywav treatment.
Your child’s doctor may give them a different dosage depending on certain factors, including whether your child has liver disease. If you have questions about the dosage that’s right for your child, talk with their doctor.
How to take
Xywav comes as an oral solution that you mix with a certain amount of water. Before bedtime, you’ll prepare each nightly dose of Xywav using the syringe and containers that come with the drug. You’ll place the prepared doses next to your bed.
Try to take each prepared dose of Xywav within 24 hours. Be sure to discard any unused doses you do not take within 24 hours.
Your doctor or pharmacist can provide step-by-step instructions on how to prepare each Xywav dose. You can also refer to the drug’s medication guide or the manufacturer’s website for idiopathic hypersomnia and dose preparation instructions.
About taking Xywav
Here is some information about key dosage issues.
- When to take: You’ll take Xywav at bedtime right before lying down. If you’re prescribed a second nightly dose, you’ll take it 2.5 to 4 hours after the first dose.
- If you miss a dose: If you miss your first dose of Xywav, take it as soon as you remember at bedtime. If you miss your second dose and it’s been more than 4 hours since your first dose, skip the missed dose. Then take your next dose the following night at the regular time.
- Taking Xywav with food:Take Xywav at least 2 hours after eating. This is because taking Xywav with food lowers the level of the drug in your body, which may make it less effective.
- Length of use: Xywav may be used as a long-term treatment. If you and your doctor determine that Xywav is safe and effective for you, you may take it long term.
- Length of time to work: For many people, Xywav works within 15 minutes after they take it. Since Xywav can work quickly to help you fall asleep, it’s important to lie down right after taking each dose.
Overdose
Taking more than the recommended dosage of Xywav can lead to serious side effects. Do not take more Xywav than your doctor recommends.
Overdose symptoms
Symptoms of an overdose can include:
- agitation
- blurred vision
- confusion
- difficulty breathing
- excessive sweating
- headache
- loss of consciousness
- seizures
- slow heart rate
- vomiting
In extreme cases, an overdose of Xywav may lead to coma.
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
Xywav can cause mild or serious side effects. The following lists contain some key side effects that may occur while taking Xywav. These lists do not include all possible side effects.
For more information about the possible side effects of Xywav, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Xywav, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Xywav. To learn about other mild side effects, talk with your doctor or pharmacist or view Xywav’s prescribing information.
Mild side effects of Xywav can include:
- diarrhea, nausea, or vomiting
- dizziness
- dry mouth
- excessive sweating
- fatigue
- headache
- loss of appetite
- sleep changes, such as insomnia or sleepiness
- tremors
These side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Xywav aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening, or you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- changes in mental health or behavior, which may include symptoms such as:
- anxiety
- confusion
- depression
- suicidal thoughts or behaviors
- parasomnia (unusual dreams or behaviors during sleep), which may include symptoms such as:
- risk of central nervous system (CNS) depression*
- risk of misuse*
* Xywav has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Xywav precautions” section.
Side effects in children
Many side effects of Xywav in children are expected to be the same as those in adults. (For lists of possible side effects, see “Mild side effects” and “Serious side effects.”) However, weight loss and bedwetting were reported more often in children than in adults.
If you have questions about how Xywav may affect your child, talk with their doctor or pharmacist.
ALLERGIC REACTIONFor some people, Xywav can cause an allergic reaction. But this side effect wasn’t reported in the drug’s clinical trials.
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.
The Food and Drug Administration (FDA) approves prescription drugs such as Xywav to treat certain conditions.
Xywav for idiopathic hypersomnia
Xywav is approved to treat idiopathic hypersomnia in adults.
Idiopathic hypersomnia is a sleep disorder that occurs without a known cause. People with this condition may feel extremely sleepy during their usual waking hours despite having a full night’s sleep. Other symptoms may include headache, sleep hallucinations, or feeling confused after waking up.
To learn more about Xywav for idiopathic hypersomnia, talk with your doctor. You can learn more about sleep by visiting our sleep hub.
Xywav for certain narcolepsy symptoms
Xywav is approved to treat certain narcolepsy symptoms in adults and children ages 7 years and older.
Narcolepsy is a sleep disorder that impacts the brain’s ability to manage sleeping and waking up. People with this condition may have sudden episodes of extreme sleepiness during usual daily activities, such as driving.
Doctors can prescribe Xywav to treat the following narcolepsy symptoms:
- Excessive daytime sleepiness. With this symptom, you may feel extremely sleepy during your usual waking hours despite having a full night’s sleep.
- Cataplexy. With cataplexy, you may have sudden muscle weakness or loss of muscle control.
To learn more about Xywav for excessive daytime sleepiness or cataplexy, talk with your doctor. You can learn more about sleep by visiting our sleep hub.
Xywav and children
Xywav is prescribed for specific narcolepsy symptoms in children ages 7 years and older. These include excessive daytime sleepiness and cataplexy. For details, see “Xywav for certain narcolepsy symptoms” above.
Your child’s doctor can tell you more about Xywav for excessive daytime sleepiness or cataplexy.
Xywav can interact with several other medications. However, the drug’s manufacturer hasn’t reported any interactions with supplements or foods.
Before taking Xywav, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
For more information about Xywav and interactions, see this in-depth article.
Interactions with medications
The following list highlights some medications that can interact with Xywav. This list does not contain all drugs that may interact with Xywav. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
| Medications that can interact with Xywav | • opioids, such as oxycodone (Oxycontin, Xtampza ER) and morphine (Mitigo, MS Contin, others) • benzodiazepines, such as alprazolam (Xanax) and lorazepam (Ativan, Loreev XR) • muscle relaxers, such as cyclobenzaprine (Amrix) and methocarbamol (Robaxin) • sedative hypnotics, such as eszopiclone (Lunesta) and zolpidem (Ambien, Edluar) • divalproex sodium (Depakote, Depakote ER) |
Alcohol interaction
It is not safe to consume alcohol while taking Xywav.
This is because drinking alcohol can increase the risk of central nervous system (CNS) depression. Xywav has a boxed warning about the risk of this side effect.*
If you have questions about avoiding alcohol while taking Xywav, talk with your doctor or pharmacist.
* A boxed warning is the most serious warning from the FDA. To learn more, see the “Xywav precautions” section.
As with all medications, the cost of Xywav can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Financial and insurance assistance:If you need financial support to pay for Xywav, or if you need help understanding your insurance coverage, help is available.
A program called JazzCares is available for Xywav. For more information and to find out if you’re eligible for support, call 833-533-5299 or visit the program website.
Generic version:Xywav is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.
To learn more about saving money on prescriptions, check out this article.
Other drugs are available that can treat idiopathic hypersomnia or narcolepsy symptoms. Some may be a better fit for you than others. If you’re interested in finding an alternative to Xywav, talk with your doctor. They can tell you about other medications that may work well for you.
Examples of drugs that are alternatives to Xywav include the following:
If you can become pregnant, consider the following information about pregnancy and breastfeeding.
Xywav and pregnancy
It is unknown whether you should take Xywav during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Xywav and breastfeeding
It is unknown whether you should take Xywav while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.
Xywav is used to treat certain sleep disorders. These include idiopathic hypersomnia and narcolepsy symptoms of excessive daytime sleepiness and cataplexy.
Xywav belongs to a class of drugs called central nervous system (CNS) depressants. This means the drug slows the activity of the CNS, which includes your brain and spinal cord.
Xywav’s mechanism of action (how it works) to treat sleep disorders is not fully understood. The drug is thought to affect chemicals that help calm the brain during sleep. This may lead to better sleep and less tiredness during the day.
To learn more about how Xywav works, talk with your doctor or pharmacist. You can also visit the drug manufacturer’s website for idiopathic hypersomnia and narcolepsy.
Here are answers to some frequently asked questions about Xywav.
How does Xywav compare with Xyrem?
Xywav and Xyrem have some similarities and differences. Both drugs are used to treat narcolepsy symptoms of excessive daytime sleepiness and cataplexy. But Xywav is also approved to treat idiopathic hypersomnia.
Both Xywav and Xyrem contain the active ingredient sodium oxybate. Xywav also contains three other active ingredients: calcium oxybate, magnesium oxybate, and potassium oxybate.
However, Xywav contains less sodium (salt) than Xyrem. For this reason, Xywav is generally a safer option for people following a low sodium diet for conditions such as high blood pressure or kidney disease.
Both Xywav and Xyrem have boxed warnings for the risks of central nervous system (CNS) depression and misuse.* Due to these risks, the drugs are available only through the Xywav and Xyrem risk evaluation and mitigation strategy (REMS) program. The healthcare professional prescribing these drugs and the pharmacist dispensing them must be certified by the REMS program.
If you have other questions about how Xywav compares with Xyrem, talk with your doctor or pharmacist.
* A boxed warning is the most serious warning from the FDA. To learn more, see the “Xywav precautions” section.
Is Xywav a stimulant, or does it help you wake up?
No, Xywav is not a stimulant drug. Instead, it belongs to a class of drugs called central nervous system (CNS) depressants.
Similar to Xywav, stimulants can be used to treat idiopathic hypersomnia and narcolepsy. However, Xywav works differently from these drugs. While stimulants help increase alertness while you’re awake, Xywav may help calm your brain during sleep.
As a result, Xywav isn’t a drug that will help you wake up. However, taking this drug may improve sleep and reduce tiredness during the day.
If you have other questions about Xywav or stimulants, talk with your doctor or pharmacist.
Is Xywav habit forming?
Yes, Xywav has the potential to be habit forming. This means that taking the drug long-term could lead to dependence. Drug dependence is when your body needs a drug to be present to function as it usually does.
Xywav also has a boxed warning for the risk of misuse.* Misuse refers to taking a drug in a way other than how a doctor prescribes it.
Because of these risks, Xywav is a controlled substance. This means that doctors and pharmacies must follow certain regulations to prescribe and dispense it.
It’s important to take Xywav exactly as your doctor has prescribed it. Do not change your dosage or adjust the way you take Xywav without talking with your doctor.
If you have other questions about the risks of taking Xywav, talk with your doctor. They can help you decide whether Xywav is the right treatment option for you.
* A boxed warning is the most serious warning from the FDA. To learn more, see the “Xywav precautions” section.
This drug comes with several precautions.
FDA warnings
This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Risk of central nervous system (CNS) depression: Taking Xywav may lead to CNS depression. This is because Xywav belongs to a class of drugs called CNS depressants. It works to treat sleep disorders by slowing down the activity of the CNS, which includes your brain and spinal cord. If the CNS is slowed down too much it may lead to serious side effects, including:
- respiratory depression (shallow or slow breathing)
- low blood pressure
- loss of consciousness
- seizures
In extreme cases, CNS depression can lead to coma or death.
Taking Xywav, even as your doctor prescribes, may lead to CNS depression. However, this risk may be increased if you take Xywav with other CNS depressants. This includes alcohol and medications such as opioids and benzodiazepines.
Keep in mind that CNS depression could affect your ability to drive safely or perform certain activities. It’s important to avoid these activities for at least 6 hours after taking a dose of Xywav.
Due to this risk, Xywav is available only through the Xywav and Xyrem risk evaluation and mitigation strategy (REMS) program. The healthcare professional prescribing the drug and the pharmacy dispensing it must be certified by this program.
If you have questions about the risk of CNS depression with Xywav, talk with your doctor.
Risk of misuse: Xywav carries a risk of misuse. With misuse, a drug is taken in a way other than how a doctor prescribes it.
Misusing Xywav may lead to serious side effects. Examples include seizures, respiratory depression, and loss of consciousness. In extreme cases, misuse can lead to coma or death.
Due to this risk, Xywav is available only through the Xywav and Xyrem REMS program. The healthcare professional prescribing the drug and the pharmacy dispensing it must be certified by this program.
If you have questions about the risk of misuse with Xywav, talk with your doctor.
Other precautions
Before taking Xywav, it’s important to 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 tell your doctor if any of the following apply to you:
- breathing problems, including sleep apnea
- mental health conditions, including suicidal thoughts or behaviors
- liver damage
- succinic semialdehyde dehydrogenase deficiency (a rare inherited condition that affects how your body breaks down Xywav)
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Xywav, see the “Xywav side effects” section.
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.
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.