We're here to help.
We welcome your
inquiries.
Safety Information[1]
XYREM® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug - which means that it has a moderate dependence risk. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.
It is very important to keep XYREM out of reach of children and pets.
XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.
The active ingredient of XYREM is gamma-hydroxybutyrate (GHB). GHB is a chemical that has been abused and misused. Abuse and misuse of XYREM can cause serious medical problems, including seizures, loss of consciousness, coma and death. Abuse of XYREM can lead to dependence, craving for the medicine, and severe withdrawal symptoms.
XYREM can cause sleep very quickly. Therefore, take XYREM only at bedtime and while in bed.
Do not drive a car, operate heavy machinery, or perform any activity that is dangeous or that requires mental alertness for at least 6 hours after taking XYREM. When you first start taking XYREM, until you know whether it makes you sleepy the next day, use extreme care while performing these activities.
You should not drink alcohol or take other medicines that cause sleepiness. You could have serious side effects.
You can get XYREM only by prescription. You must get it through the central pharmacy. Before you first receive XYREM, your doctor or the central pharmacy will confirm that you understand how to use the drug safely and effectively.
You should see your doctor at least every 3 months. It is critical to keep those appointments to continue your XYREM therapy. Also, be sure to check in with your doctor during the first several weeks on XYREM regarding potential changes in your dose.
Download the complete XYREM Medication Guide.
References:
- ^ The XYREM Success Program® for Patients, Jazz Pharmaceuticals, Inc.
Important Safety Information
1. XYREM® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.
2. It is very important to keep XYREM out of reach of children and pets.
3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.
BOXED WARNING:
!Warning
Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of 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.
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).
XYREM is available through the XYREM Success Program®, using a centralized pharmacy 1-866-XYREM88® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.
