"Low doses of the muscle relaxant cyclobenzaprine https taken at bedtime help people with fibromyalgia https sleep better and feel less pain https according to a small study. Bedtime treatment of fibromyalgia patients with lowdose cyclobenzaprine was safe and appears to be effective says Seth Lederman MD president of TONIX Pharmaceuticals which funded the study. Fibromayalgia is a condition marked by fatigue https disturbed sleep and pain. About  million Americans have fibromyalgia. Cyclobenzaprine marketed in higher doses by others as Amrix https Fexmid https and Flexeril https is already widely used offlabel for patients with fibromyalgia Lederman says. Offlabel refers to the practice of prescribing medicines to treat conditions not been specifically approved by the FDA.  TONIX is developing a lowerdose version and improving the formula Lederman says. However a rheumatologist not connected to the study does not expect the new drug to be a gamechanger. The results of the study are published online in The Journal of Rheumatology. Treatment for Fibromyalgia Lederman and other researchers from the University of Toronto randomly assigned  fibromyalgia patients to take cyclobenzaprine beginning at a dose of  milligram a day and another  to the placebo group. Doses were increased as needed up to  milligrams a day. Some other cyclobenzaprine products come as milligram or milligram tablets. Twentynine patients completed the eightweek study. At the end the researchers found that sleep quality improved. The total sleep time increased from an average of . hours to . hours in the treated group. Fatigue decreased somewhat. Other results include  Pain declined  in the drug group over the study. That was  more than in the placebo group.  Tenderness improved  in the drug group. That was  more than in the placebo group. Tenderness affects specific points on the body that are extrasensitive to touch.  Depression https declined  in the drug group   more than in the placebo group. The side effects reported were similar for both groups. Headache https was the most common side effect reported in the drug group. Some also had dry mouth and drowsiness. Although three other drugs https are approved for treatment of fibromyalgia Lederman says they are all daytime treatments. None of the muscle relaxant medications is approved for fibromyalgia treatment https The higherdose muscle relaxants can sometimes produce excessive daytime drowsiness he says. A lack of sleep is thought to make symptoms of fibromyalgia https worse Lederman says. Once sleep is restored as he reports it was in his study the daytime symptoms may improve too. More study is needed to see if the new treatment is better than existing treatments. If all goes well Lederman says the medicine could be on the market as early as . He cannot estimate how much the medicine might cost. Second Opinion Brian Walitt MD MPH an assistant professor of medicine at Georgetown University is not impressed with the findings. He reviewed the study findings for WebMD but was not involved in the research. Referring to the  difference in pain reported between the drug and placebo groups Walitt asks If you have fibromyalgia are you really looking to be  better Overall the new drug dose if approved is not going to change things substantially for people with fibromyalgia says Walitt who is also associate director of rheumatology at the Washington Hospital Center."