Sodium Oxybate (Xyrem) Helpful in Fibromyalgia

As we have noted for years, an old natural remedy called GHB (Gamma Hydroxy Butyrate) was very safe and effective for sleep and wonderful for fibromyalgia. It increased stage 4 deep sleep and growth hormone release better than any prescription and was cheap, safe, and natural. Anyone could get it easily. So of course the government made it illegal.

The government's story? The DEA decided they were going to go after "club drugs" including date rape drugs. I consider this a laudable goal, but IMHO this meant going after Rohypnol (the drug actually used for date rape) — not GHB. The amount of GHB that it would take to knock one out would taste awful and would not be feasible.

Because it was safe and cheap, many physicians (I included) guessed that GHB would come out as as an expensive medication a year after being made illegal — which it did. It went from cheap, easy to take, GHB capsules for 30-90 cents a night to a nasty, teeth rotting liquid at $18 a night — with major paperwork.

Despite being another example of a government regulation causing much more harm than good, in cases of severe insomnia unresponsive to other medications, Xyrem is a reasonable option — if your insurance will pay for it. If you fall asleep easily during the day, ask your MD to consider adding a diagnosis of narcolepsy (common in FMS and can be confirmed with a MSLT test if you'd like — though the test may not be worth the cost). A diagnosis of narcolepsy usually means your insurance will pay for the Xyrem. Xyrem knocks you out for 4 hours, and then you can repeat a second dose. Even with having to come off all other sleep meds in the study below, fibromyalgia patients had improved sleep and less pain! If you have side effects on it, ask your physician to raise the dose so you sleep through the side effects. It can be very helpful, and most Fibromyalgia and Fatigue Center physicians know how to go through the paperwork for their patients to get it.

See the press release below for more information.

Press Release

NEW YORK (Reuters Health) Jan 21, 2009 — Sodium oxybate relieves pain and improves function, with few adverse events, in patients with fibromyalgia syndrome, researchers report in the January issue of Arthritis and Rheumatism.

"Sodium oxybate therapy was well tolerated and significantly improved the primary outcome variables," lead investigator Dr. I. Jon Russell told Reuters Health. "In addition, significant improvement was seen with many of the secondary outcome variables which addressed a wide variety of the fibromyalgia syndrome symptoms."

Dr. Russell of University of Texas Health Science Center at San Antonio and colleagues came to this conclusion following a study involving 188 patients. After discontinuing their prestudy medications, the patients were randomized to 4.5 gm or 6 gm of sodium oxybate or matching placebo once nightly for 8 weeks.

"Sodium oxybate is the sodium salt of gamma-hydroxybutyrate, a metabolite of gamma-aminobutyrate acid," the investigators explain. The drug is currently approved by the U.S. Food and Drug Administration to address cataplexy and symptoms of daytime sleepiness in narcolepsy patients.

One hundred forty-seven patients (78%) completed the trial. Intention-to-treat analysis showed significant benefit with both doses of the agent, based on patient self-reports of pain, sleep outcomes and quality of life. Improvements in their visual analogue pain score were significantly correlated with sleep outcomes.

Less than 28% of patients reported dose-related nausea and less than 18% reported dose-related dizziness. Most episodes tended to resolve and caused few patients to withdraw from the study.

The investigators conclude that "this proof-of-concept study suggests that sodium oxybate is effective and safe for the management of fibromyalgia syndrome symptoms," and that further investigation is warranted.

References

Arthritis Rheum 2009;60:299-309.