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In this Article

• 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 should I discuss with my healthcare provider before taking 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.

Do not take sodium oxybate 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 this medication:

• 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.

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.

FDA pregnancy category B. Sodium oxybate 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 this medication without telling your doctor if you are breast-feeding a baby.

How should I take sodium oxybate (Xyrem)?

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

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.

Each dose of sodium oxybate 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 sodium oxybate 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 sodium oxybate, especially if you have high blood pressure, kidney disease, or heart disease.

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.

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 sodium oxybate suddenly or you may have withdrawal effects. Your doctor may recommend a gradual reduction in dose.

Store sodium oxybate at room temperature away from moisture and heat.

Keep track of how much of this medicine has been used from each new bottle. Sodium oxybate 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.