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Xyrem

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Treatment & Uses
Side Effects
Treating Overdose
Safety Information
Before Using

Generic Name: sodium oxybate (SO dee um OX i bate)
Brand Names: Xyrem

What is Xyrem?

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Xyrem (sodium oxybate) is a central nervous system depressant.

Xyrem is used to reduce the number of cataplexy attacks (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.

Xyrem may also be used for other purposes not listed in this medication guide.

Important information about Xyrem

It is dangerous to try and purchase Xyrem on the Internet or from vendors outside of the United States. The sale and distribution of Xyrem outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only through a special program. Your doctor will explain the risks and benefits of using Xyrem, and the medication will be delivered to you from a central pharmacy.

Xyrem may be habit-forming and should be used only by the person it was prescribed for. Xyrem should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Never take more than your prescribed dose of Xyrem. Tell your doctor if the medicine seems to stop working as well.

Xyrem will cause drowsiness and must be taken while you are in bed. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking Xyrem. You may still feel sleepy the morning after taking the medication. Use caution when driving or doing anything else that requires you to be alert and awake.

Xyrem must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed, so that you will not have to get up to prepare the second dose. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.

Do not take other medicines that make you sleepy (such as alcohol, cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

Before taking Xyrem

It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of the United States. The sale and distribution of Xyrem outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

Do not take Xyrem if you:

are taking another medication that causes drowsiness; or
have a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Xyrem:

liver disease;
heart disease, high blood pressure, or kidney disease;
a history of alcohol or drug abuse;
a lung disorder such as asthma, emphysema, or bronchitis;
sleep apnea (breathing stops during sleep);
depression or suicidal thoughts; or
mental illness such as bipolar disorder or schizophrenia.

FDA pregnancy category B. Xyrem is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sodium oxybate passes into breast milk or if it could harm a nursing baby. Do not use Xyrem without telling your doctor if you are breast-feeding a baby.

How should I take Xyrem?

Take Xyrem exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Never take more than your prescribed dose of Xyrem. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Do not allow anyone else to use your medication.

Take Xyrem on an empty stomach several hours after a meal. It is important to take Xyrem at the same time each night.

Each dose of Xyrem must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any dose that has been mixed with water but not used within 24 hours of mixing.

You may need to be on a low-salt diet while you are using Xyrem, especially if you have high blood pressure, kidney disease, or heart disease.

To be sure this medication is helping your condition, your doctor will need to see you on a regular basis. Do not miss any scheduled appointments.

Do not stop using Xyrem suddenly or you may have withdrawal effects. Your doctor may recommend a gradual reduction in dose.

Store this medicine at room temperature away from moisture and heat. Keep track of how much of this medicine has been used from each new bottle. Xyrem is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but only at bedtime or during your normal sleeping hours. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme sleepiness or confusion, fainting, vomiting, sweating, difficulty breathing, muscle weakness, slow heartbeat, or seizure (convulsions).

What should I avoid while taking Xyrem?

Xyrem must not be taken with other drugs that are used for sleep or sedation.

Avoid drinking alcohol while taking sodium oxybate. Alcohol may increase drowsiness and dizziness caused by Xyrem. Sodium oxybate can cause side effects that may impair your thinking or reactions. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking Xyrem. You may still feel sleepy the morning after taking the medication. Use caution when driving or doing anything else that requires you to be alert and awake

Xyrem side effects

Stop using Xyrem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Xyrem and call your doctor at once if you have any of these serious side effects:

hallucinations or severe confusion;
shallow breathing;
sleepwalking; or
waking and confused behavior at night.

Less serious Xyrem side effects may include:

agitation or paranoia;
problems with bladder or bowel control;
depression;
nausea, vomiting, loss of appetite;
runny or stuffy nose and sore throat;
numbness or tingling;
tremors (uncontrolled shaking); or
blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xyrem?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Xyrem. Tell your doctor if you regularly use any of these medicines.

This list is not complete and there may be other drugs that can interact with Xyrem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Xyrem.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.