a neurochemical involved in regulating metabolism which is also able to affect sleep. Sodium oxybate is the active ingredient in Xyrem. Xyrem has been approved to treat narcolepsy (severe daytime sleepiness) and cataplexy (sudden muscle weakness).
Zyrem was developed by the Office of Orphan Products Development (OOPD) – a department of the FDA dedicated to producing drugs for rare conditions. Acquired by Jazz Pharmaceuticals in the US in 2005 Xyrem is currently approved to treat narcolepsy. Currently undergoing Phase III trials for fibromyalgia (FM), Xyrem is also being studied in CFS, Parkinson’s, schizophrenia, essential tremor and others.
Xyrem May Work in ME/CFS/FM Because..
It is able to reduce the frequency of abnormal brainwaves (called alpha intrusions) that appear to impair deep sleep in many CFS and fibromyalgia patients. It is also one of the only drugs known to improve both sleep and reduce pain. Xyrem may enhance the activity of two neurotransmitters, dopamine and serotonin, both of which may be deficient in ME/CFS as well as growth hormone production. The highest concentrations of GHB are found in two areas of the brain; the hypothalamus and basal ganglia, that are of interest to CFS and FM researchers.
ME/CFS Physicians Report
Dr. Teitelbaum flatly states “Xyrem is the most effective way known to increase deep sleep and raise growth hormone”. Dr. Peterson reported that to his ‘amazement’ Xyrem helped with both sleep and pain in his patients with sleep disorders. Drs. Ross and Marion Hauser call it ‘probably one of the safest and most effective sleep aids that we know of.” They believe it may enhance growth hormone levels. Dr. Klimas notes that Xyrem it induces ‘slow wave’ sleep – the type of sleep most ME/CFS patients have the most trouble achieving.
Chronic Fatigue Syndrome and Fibromyalgia Studies
Currently in Phase III Clinical Trials for FM, Xyrem has been the focus of several extensive studies.A large 2012 trial found that from 42-50% of patients reported a greater than 30% reduction in pain. A 2011 trial containing over 500 patients found that from 55-60% of patients experienced a 30% drop in pain and significantly reduced fatigue and sleep disturbances. Subjective sleep quality was increased in a 2009 FM study.
A 2010 Spitzer retrospective study found that 60% and 75% of 118 CFS/FM patients experienced significant reductions in pain and/or fatigue. Two studies have found improved sleep and about a thirty percent reduction in fatigue and pain scores in fibromyalgia. Of particular interest was Xyrem’s abiity to reduce the frequency of anomalies observed in both FM and ME/CFS during sleep called alpha intrusions. Alpha intrusions involve the appearance of unusual high frequency brainwave patterns that are believed to disrupt deep sleep.
Dr. Teitelbaum recommends 9 cc’s (4.5 grams) at bedtime and then about 4 hours later if needed. Xyrem is fast acting and should be taken in bed.
Xyrem can be habit forming. Patients in clinical trials reported confusion (2.5%), depression (3.5%), incontinence at some point (7%), sleepwalking (4%). Headache (22%), nausea (21%) and dizziness (17%) and others were also found.
Do not take other sleep enhancing substances (alcohol, pain medication, muscle relaxants, sedative hypnotics, etc.) when taking Xyrem. Xyrem should be discontinued gradually. Rinse well with water and swallow after taking as Xyrem can damage tooth enamel.
GHB is known as the GHB is known as the date rape drug because of its ability to induce amnesia when combined with alcohol. It can only be obtained from a special compounding pharmacy. According to Dr. Staud, Xyrem’s cost is now up to about $30,000 a year. Jazz Pharmaceuticals has hiked the price up 220% since 2008 and some analysts expect another 70% boost by 2014.
Pain. 2011 May;152(5):1007-17. Epub 2011 Mar 11.Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study.Russell IJ, Holman AJ, Swick TJ, Alvarez-Horine S, Wang YG, Guinta D; Sodium Oxybate 06-008 FM Study Group.
Arthritis Rheum. 2009 Jan;60(1):299-309. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia Syndrome Study Group.
Scharf MB, Baumann M, Berkowitz DV, J Rheumatol. 2003 May;30(5):1070-4. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia.
Jacob Teitelbaum, MD., 2007. From Fatigued To Fantastic 3rd. ed., Avery Publishing.’
Sodium oxybate [Xyrem] for the treatment of Fibromyalgia – Source: Expert Opinion on Pharmacotherapy, Jun 16, 2011. ProHealth.com by Roland Staud