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Xyrem (sodium oxybate)
Questions and Answers

  1. What is Xyrem?
  2. Why is FDA approving GHB now?
  3. Why did FDA previously ban the sale of GHB?
  4. Will Xyrem be available by prescription only?
  5. What is the Xyrem Success Program?
  6. Is Xyrem classified as a controlled substance?
  7. What are some possible side effects of taking GHB?
  8. What should patients avoid while taking GHB?
  9. How will Xyrem be supplied?
  10. What should a patient do with unused Xyrem?
  11. Where can I get more information?
1.  What is Xyrem?

Xyrem is a drug whose active ingredient is sodium oxybate, commonly known as gamma hydroxybutyrate or GHB. Xyrem is used to reduce the number of cataplexy attacks in patients with narcolepsy. Cataplexy is a condition characterized by weak or paralyzed muscles.

2.  Why is FDA approving GHB now?

The FDA has approved Xyrem, manufactured by Orphan Medical, as a safe and effective medication for use in a limited population when properly prescribed. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted.

3. Why did FDA previously ban the sale of GHB?

In the early 1990s, GHB was marketed as a dietary supplement for many claimed purposes, including inducing sleep, releasing growth hormone, enhancing sexual activity and athletic performance, and relieving depression. It also gained favor as a recreational drug, and was used for date rape, because of its intoxicating effects.

Many serious adverse, events including deaths, were reported with the use and misuse of the GHB containing products. As use increased, so did the adverse event reports. That prompted FDA to make several public announcements alerting consumers to the dangers surrounding GHB and similar products.

While these products were listed as "party drugs" on Internet sites, advertised in muscle-building magazines, and sold in health food stores as dietary supplements, the FDA considered them to be unapproved new drugs and seizured the products to prevent their sale to consumers and any further illnesses or deaths.

However, since that time, Orphan Medical has conducted studies that show GHB is useful in reducing the number of cataplexy attacks in patients with narcolepsy.

4. Will Xyrem be available by prescription only?

Yes, Xyrem will be available by prescription only through a restricted distribution program, called the Xyrem Success Program.

5. What is the Xyrem Success Program?

The Xyrem Success Program is a limited distribution program designed to ensure safe use of the drug. Under the program, Xyrem will be available to prescribers through a single centralized pharmacy (1-866-XYREM-88 or 1-866-997-3688).  The program involves many risk management components, such as:

  • physician education
  • patient education
  • registration
  • detailed patient surveillance

6.  Is Xyrem classified as a controlled substance?

Yes,  Xyrem for proper medical use is controlled under Schedule III of the Controlled Substances Act (CSA). Illicit use of Xyrem will be subject to penalties under Schedule I, the most restrictive schedule of the CSA. This means that anyone who sells, distributes, or gives Xyrem to anyone else, or who uses Xyrem for purposes other than what it is prescribed for, may be punished under Federal and state law by jail and fines.

7. What are some possible side effects of taking GHB?

Xyrem can cause serious side effects including:

  • trouble breathing while asleep
  • confusion
  • abnormal thinking
  • depression
  • loss of consciousness.

Abuse of Xyrem could also lead to dependence, craving for the medicine, and severe withdrawal symptoms

8. What should patients avoid while taking GHB?

Xyrem may interfere with the ability to do certain things that require full attention.

  • Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem.
  • Do not drink alcohol or take sedatives. Alcohol and certain medicines can increase the chance of dangerous side effects.

9. How will Xyrem be supplied?

Xyrem will be supplied as an oral solution.

10. What should a patient do with unused Xyrem?

Patients should NEVER share Xyrem or any other prescription drug with anyone. Patients should consult the Medication Guide or the Patient Success Program, or contact the central pharmacy at 1-866-XYREM-88 (1-866-997-3688) to learn about the best way to dispose of any medication.

11. Where can I get more information?

The Xyrem Success Program includes detailed information about the safe and proper use of the medicine, as well as information to help the patient prevent accidental use or abuse of Xyrem by others. The Medication Guide summarizes the most important information about Xyrem. If you want more information, talk to your physician, or call the central pharmacy toll free number 1-866-XYREM-88 (1-866-997-3688).

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FDA/Center for Drug Evaluation and Research
Last Updated: July 17, 2002
Originator: OTCOM/DLIS
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