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What is XYREM®?
XYREM is a prescription medication that has been approved for the treatment of narcolepsy, to:[1][2]
- Reduce too much daytime sleepiness
(Excessive Daytime Sleepiness occurs in 100% of narcolepsy patients) - Reduce cataplexy (weak or paralyzed muscles attacks)
(Cataplexy occurs in 60-100% of narcolepsy patients)
Source: [3][4]
XYREM taken at night has been proven to help people with narcolepsy to stay awake better during the day and to have fewer cataplexy attacks.[1]
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.[1]
If you have been prescribed XYREM, see Getting Started with XYREM for information and tips on how to safely fill, take, and store your XYREM prescription.
Safety Information[1]
The active ingredient of XYREM is a form of gamma-hydroxybutyrate (GHB). GHB is a chemical that has been abused and misused. Abuse and misuse of XYREM can cause serious medical problems, which may include seizures, loss of consciousness, coma and death. Abuse of XYREM can lead to dependence, which may include craving for the medicine and severe withdrawal symptoms.
References:
- ^ XYREM® Medication Guide, Jazz Pharmaceuticals, Inc.
- ^ Bassetti C, Aldrich MS. Narcolepsy. Neurol Clin. 1996;14:545–571.
- ^ The XYREM® International Study Group. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1:391–397.
- ^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals; 2005.
- ^ The US XYREM® Multicenter Study Group. A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25:42–49.
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.
