Xyrem (Sodium Oxybate) for Fibromyalgia

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Sodium oxybate is the active ingredient in the narcolepsy drug Xyrem, which has been studied for fibromyalgia (FMS) and is sometimes used off-label for FMS and chronic fatigue syndrome (ME/CFS).

This drug carries a risk of addiction and abuse, so it's classified as a Schedule III controlled substance. That means it's only available to people meeting strict eligibility requirements, and doctors are required to monitor its use very closely.

Sodium oxybate is a form of gamma-hydroxybutyrate (GHB), which is also known as the "date rape drug."

What It Does

Sodium oxybate is a central nervous system depressant that's thought to help you attain the deeper stage 3 and stage 4 levels of sleep. It's currently approved in the U.S. for reducing daytime sleepiness and cataplexy (sudden loss of muscle strength) in people with narcolepsy.

Deep sleep is believed to be impaired in FMS and ME/CFS, resulting in unrefreshing sleep.

For Fibromyalgia and Chronic Fatigue Syndrome

The FDA in 2010 rejected sodium oxybate as a treatment not because it doesn't work, but because the agency was concerned about the societal consequences of making a potentially dangerous drug available to millions of people.

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.

A 2010 study (Spitzer) suggested it may be effective in ME/CFS as well, but this was the first study of this drug for ME/CFS.


Sodium oxybate is taken in liquid form, mixed with water. A typical starting dose for patients with narcolepsy is 4.5 grams a night, divided into 2 equal nightly doses. People frequently work up to 6-9 grams nightly, still in 2 equal doses.

Generally, patients are advised to prepare both doses and put them on the nightstand, then take the first one while sitting in bed. You might need an alarm clock to wake you up for the second one. This drug works quickly, so you should stay in bed once you've taken it.

Side Effects

Stop using sodium oxybate and get immediate medical help if you have symptoms of an allergic reaction, such as:

  • Difficulty breathing
  • Hives
  • Swelling of the face, lips, tongue or throat

Stop using sodium oxybate and call your doctor right away if you have serious side effects, which include:

  • Hallucinations
  • Severe confusion
  • Shallow breathing
  • Sleepwalking
  • Waking up confused during the night

Other side effects may be less serious, including:

  • Agitation
  • Paranoia
  • Bowel or bladder control problems
  • Depression
  • Nausea or vomiting
  • Loss of appetite
  • Runny nose or nasal congestion and sore throat
  • Numbness or tingling
  • Tremors
  • Blurred vision

It's possible for you to have side effects not listed here. Be sure to discuss side effects with your doctor.

Getting Sodium Oxybate

Doctors can prescribe sodium oxybate off-label if they choose. However, because of the risks, it's not easy to get sodium oxybate.

For you to get it, your doctor has to enroll you in a special program.

The prescription then goes to the only pharmacy in the U.S. that's allowed to fill it, and the pharmacy ships the medication to you.

If you want to try sodium oxybate, talk to your doctor. Keep in mind, though, that some doctors may be uncomfortable prescribing it.


NIH Publication NO. 04-5326.

June 2007, U.S. Food and Drug Administration, "Living with Fibromyalgia".

Russell IJ, et al. Pain. 2011 May;152(5):1007-17. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study.

Spaeth M, et al. Annals of the rheumatic diseases. 2012 Jun;71(6):935-42. Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial.

Spaeth M, et al. Arthritis research and therapy. 2013 Nov 11;15(6):R185. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia.

Spitzer AR, Broadman M. Pain practice. 2010 Jan-Feb;10(1):54-9. Treatment of the narcoleptiform sleep disorder in chronic fatigue syndrome and fibromyalgia with sodium oxybate.

Staud R. Expert opinion on pharmacotherapy. 2011 Aug;12(11):1789-98. Sodium oxybate for the treatment of fibromyalgia.

Swick TJ. Therapeutic advances in musculoskeletal disease. 2011 Aug;3(4):167-78. Sodium oxybate: a potential new pharmacological options for the treatment of fibromyalgia syndrome.