Is Xyrem approved for fibromyalgia?
Aug. 20, 2010 — An FDA advisory panel today overwhelmingly rejected the application of Jazz Pharmaceuticals for the approval sodium oxybate (Xyrem) for the treatment of fibromyalgia. The drug is chemically similar to GHB, widely considered a date-rape drug.
How does Xyrem help fibromyalgia?
For Fibromyalgia and Chronic Fatigue Syndrome Clinical trials on FMS have consistently shown that the drug can significantly improve sleep quality and reduce pain. A 2013 study (Spaeth) concluded that it had a good long-term safety profile as well.
What is the standard treatment for fibromyalgia?
The FDA has approved three drugs specifically for treating fibromyalgia, including pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella). However, other medications, such as amitriptyline (Elavil), cyclobenzaprine (Flexeril) or gabapentin (Neurontin) are usually considered first-line treatments.
Is sodium oxybate addictive?
Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine. Use the medicine exactly as directed. Sodium oxybate may be habit-forming. Misuse can cause addiction, overdose, or death.
What is Xyrem prescribed for?
Xyrem (sodium oxybate) Oral Solution is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) with an orphan disease designation to treat cataplexy (a condition where patients suddenly lose muscle tone, including voluntary muscle control, while awake) and excessive daytime sleepiness in …
How do you get sodium oxybate?
Sodium oxybate is available only from a certified pharmacy. Do not allow anyone else to use your medication. Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Avoid taking other medicines that make you sleepy or slow your breathing.
Who can prescribe Xyrem?
Only doctors enrolled in the Xyrem REMS program can prescribe Xyrem. To become certified, doctors must complete a one-time enrollment and be familiar with the Xyrem prescribing information.
Is gabapentin used for fibromyalgia?
The most commonly used anticonvulsants for fibromyalgia are pregabalin and gabapentin. These are normally used to treat epilepsy, but research has shown they can improve the pain associated with fibromyalgia in some people. Some common side effects of pregablin and gabapentin include: dizziness.
What are the side effects of misuse of Xyrem?
Abuse and misuse of XYREM can cause serious medical problems including seizures, trouble breathing, changes in alertness, coma, and death. XYREM can cause serious side effects including trouble breathing or changes in alertness.
How is Xyrem used to treat narcolepsy?
XYREM is a prescription medicine used to treat the following symptoms in people who fall asleep frequently during the day, often at unexpected times (narcolepsy): suddenly weak or paralyzed muscles when they feel strong emotions (cataplexy) excessive daytime sleepiness (EDS) in people who have narcolepsy.
Where can I get a prescription for Xyrem?
Because of these risks, XYREM is available only by prescription and filled through the central Certified Pharmacy in the XYREM REMS Program. Both patients and their doctors have to join this Program. XYREM is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:
Why is Xyrem considered a controlled substance ( CIII )?
XYREM is a controlled substance (CIII) because the active ingredient is a form of gamma hydroxybutyrate, or GHB, a chemical that has been abused and misused. Abuse and misuse of XYREM can cause serious medical problems including seizures, trouble breathing, changes in alertness, coma, and death.