Xyrem Online, Description, Chemistry, Ingredients - Sodium oxybate

Sodium oxybate is GHB,a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants; whether this affected respiration during the night is unknown. Xyrem^® is available only through restricted distribution, the Xyrem Success Program^SM,by calling 1-866-XYREM88^SM (1-866- 997-3688).

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g.,dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

Under the Xyrem Success Program^SM, Xyrem^® is made available to prescribers through a single centralized pharmacy and with the following procedures:1) The prescriber must contact the centralized pharmacy (1-866-XYREM88^SM),which will provide the prescriber with educational materials explaining the risks and proper use of sodium oxybate, and the details of the program. 2) Once the prescriber has read the materials and returned the necessary form, the pharmacy will ship educational materials to the patient. 3) Once it is documented that the patient has read the materials, the drug will be shipped to the patient. The Xyrem Success Program^SM also includes provisions for detailed surveillance of the patients (patients are to be seen no less frequently than every 3 months and physicians are expected to report all serious adverse events to the manufacturer) and information to help minimize the risks of inadvertent use by others (See WARNINGS).