Derek Enlander, M.D., a New York City and Long Island clinician who specializes in ME/CFIDS (myalgic encephalomyelitis/chronic fatigue immune dysfunction sydnrome) and FMS (fibromyalgia syndrome), read about the drug, Xyrem (sodium oxybate, Orphan Drug Corporation) and got permission and funding to hold a pilot trial to see if it would help the sleep during the REM cycle of patients.  Of the ten patients who participated in the twelve week trial, according to Dr. Enlander, "Seven patients had substantial improvement in their sleep pattern; this related to sleep onset, length of sleep and the feeling of restorative sleep."  Two patients participating in the trial had to drop out due to the adverse side effect of nausea and one was traveling and could not complete the study. 

     Of the majority who were helped by Xyrem, said Dr. Enlander, "Hepatic function and renal function were monitored prior, during and after the trial.  No side effects were noted."  He used the SF 25 questionnaire and found an improvement in mental and physical scoring where the patients felt their cognitive dysfunction and their fatigue levels were helped.  Both liver and kidney function as well as cardiac enzymes were monitored in patients.  It is hoped that the improved REM cycle will have a direct relationship  to decreased fatigue and improved cognition.

     We applaud the physician who goes out of his way to see if investigative new drugs will help the symptoms of ME/CFIDS!  Orphan Medical, subsequently, announced that it would enroll 150 patients for assessing the impact of the drug on fibromyalgia for a randomized, blinded trial.  The trials will be conducted throughout the United States and Canada and initial results are expected by 2005.

     The Food and Drug Administration approved Xyrem, also known as GHB, for a small population of those with narcolepsy who have cataplexy.  Cataplexy is characterized by weak or paralyzed muscles.