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Brand Names: Xyrem

Generic Name: sodium oxybate (Pronunciation: SO dee um OX i bate)

• What is sodium oxybate (Xyrem)?
• What are the possible side effects of sodium oxybate (Xyrem)?
• What is the most important information I should know about sodium oxybate (Xyrem)?
• What should I discuss with my healthcare provider before taking sodium oxybate (Xyrem)?
• How should I take sodium oxybate (Xyrem)?
• What happens if I miss a dose (Xyrem)?
• What happens if I overdose (Xyrem)?
• What should I avoid while taking sodium oxybate (Xyrem)?
• What other drugs will affect sodium oxybate (Xyrem)?
• Where can I get more information?

What is sodium oxybate (Xyrem)?

Sodium oxybate is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.

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

What are the possible side effects of sodium oxybate (Xyrem)?

Stop using sodium oxybate 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 sodium oxybate 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 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 is the most important information I should know about sodium oxybate (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 sodium oxybate 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, sodium oxybate is available only through a special program. Your doctor will explain the risks and benefits of using sodium oxybate, and the medication will be delivered to you from a central pharmacy.

Sodium oxybate may be habit-forming and should be used only by the person it was prescribed for. Sodium oxybate 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 sodium oxybate. Tell your doctor if the medicine seems to stop working as well.

Sodium oxybate 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 sodium oxybate. 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.

Sodium oxybate 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).