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CENTRAL NERVOUS SYSTEM DEPRESSION and MISUSE AND ABUSE.
Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients. Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see WARNINGS AND PRECAUTIONS].
Xyrem® (sodium oxybate) is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see WARNINGS AND PRECAUTIONS].
Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem Success Program®, using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88® (1-866-997-3688). [see WARNINGS AND PRECAUTIONS].
Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:
Sodium oxybate is a white to off-white, crystalline powder that is very soluble in aqueous solutions. Each mL of Xyrem contains 0.5 g of sodium oxybate in USP Purified Water, neutralized to pH 7.5 with malic acid.
What are the possible side effects of sodium oxybate (Xyrem)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using sodium oxybate and call your doctor at once if you have:
- hallucinations (seeing or hearing things), severe confusion;
- depression, agitation, unusual or unpleasant thoughts;
- suicidal thoughts or actions;
- shallow breathing;
- sleepwalking; or
- waking and confused behavior at night.
Common side effects may...
What are the precautions when taking sodium oxybate (Xyrem)?
Before taking sodium oxybate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency), liver disease, kidney disease, breathing problems (e.g., sleep apnea), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., heart failure, high blood pressure), mental/mood problems (e.g., depression, family/personal history of suicidal thoughts/attempts).
Sleep disorders may decrease your ability to...
Last reviewed on RxList: 4/28/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Xyrem Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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