Although the role of melatonin in the management of sleep disturbance in ME/CFS remains uncertain, some people do use this product and claim that it is of benefit. But, with the Department of Health expressing concerns over safety, most doctors have been unwilling to prescribe melatonin and instead leave patients to search out their own source of supply.
One of the worrying aspects to do-it-yourself treatment with melatonin is that supplies are often obtained over the internet, sometimes from overseas – where there may be no guarantees about quality or safety.
The pharmaceutical company Lundbeck has just sent out a mailing to UK doctors informing them about the availability of a prolonged-release preparation of synthetic melatonin (known as Circadin) as a prescription only medicine.
Circadin has been licensed for use in the short-term treatment of primary insomnia (ie poor quality sleep) in patients who are 55 or over. It is not recommended for use in children and adolescents under the age of 18.
The suggested treatment regime is a 2mg tablet taken once daily following food, one to two hours before going to bed. Treatment should continue for three weeks.
Product information for Circadin contains detailed advice about medical cautions and contra-indications to its use (including liver damage, hereditary galactose intolerance and LAPP lactase deficiency); drug interactions (eg fluvoxamine, cimetidine, carbamazepine, oestrogens in contraceptive or hormone replacement therapy) and possible adverse effects (eg drowsiness, headaches, memory problems, mood alteration, vertigo, white blood cell and platelet disturbances)
It should, however, be noted that Circadin is only being recommended for primary insomnia in people aged 55 and over.
Doctors will therefore take a very cautious view about prescribing this product to people with ME/CFS, especially as the manufacturer also states that it is not recommended for use in people with autoimmune diseases (there is some evidence for an autoimmune immunological component to ME/CFS). However, doctors may be willing to consider doing so in certain circumstances.
Medical references to melatonin and ME/CFS:
Van Heukelom et al. Influence of melatonin on fatigue in severely affected in patients with chronic fatigue syndrome and late melatonin secretion. European Journal of Neurology, 2006, 13, 55 – 60.
Williams G et al. Therapy of circadian rhythm disorders in chronic fatigue syndrome: no symptomatic improvement with melatonin or phototherapy. European Journal of Clinical Investigation, 2002, 32, 831 – 837.
- Section 7:4 of ‘ME/CFS/PVFS – An Exploration of the Key Clinical Issues' contains more information on melatonin and other drugs that may be useful in helping to correct sleep disturbance in ME/CFS.The MEA would be interested to hear from anyone who has received Circadin on prescription.
Dr Charles Shepherd
Hon Medical Adviser, The ME Association