Guidance for the prescribing and dispensing of melatonin.
From the Area Drug and Therapeutics Committee Melatonin is used to treat sleep disorders in children with neurological disorders, neuro-developmental disorders, (including Attention Deficit Hyperactivity Disorder, and autism) and visual impairment. Treatment is usually initiated by a consultant. In adults, Circadin 2mg is licensed for insomnia for short term use only. Licensed melatonin preparations are not available for use in children and prescriptions are being filled by a wide variety of unlicensed ‘specials’ of variable quality and cost. Two licensed preparations for melatonin are available: Circadin 2mg sustained release tablets, licensed in the UK to treat adults aged 55 years and over, and Bio-Melatonin 3mg immediate release tablets, licensed in Europe (but not the UK). Another manufacturer, PENN, is licensed to manufacture melatonin in the UK, but the product but is not licensed as a medicine. Prescribers are therefore asked to write prescriptions for oral melatonin as: Circadin 2mg MR tablets for doses of 2mg, 4mg, or 6mg daily (first choice) Bio-Melatonin 3mg tablets for doses of 3mg, 6mg or 9mg daily (second choice) For patients with swallowing difficulties, Bio-Melatonin tablets can be crushed and sprinkled on food or mixed with water, milk or yoghurt. Where there are swallowing difficulties, this is the preferred choice. The tablets can also be dispersed in water and administered via a PEG tube (must not be added directly to PEG feed). Being a licensed medicinal product, albeit in Europe, means that Bio-Melatonin 3mg tablets comply with the regulatory standards required for medicinal products; products available as supplements do not have to, and indeed may not, comply with these standards. Melatonin is generally well tolerated and no significant adverse effects have been reported for the licensed products. A starting dose of melatonin is given 20-30 minutes before the desired sleep time; if there has been an insufficient response after 7-10 days, the dose can be increased to 6mg (in some cases 9mg may be required). Circadin 2mg MR tablets are available through wholesalers and cost £15.39 for 30 tablets. Bio-Melatonin 3mg tablets are readily available, and the product packaging and Patient Information Leaflet are printed in English. They can be obtained directly from Pharmanord (UK), Telford Court, Morpeth, Northumberland NE61 2DB (telephone 01670 519989; FAX 01670 534903). The e-mail address is email@example.com. The cost is £16.83 for 60 tablets. Melatonin is also available in other strengths and formulations but these are more expensive than Circadin 2mg tablets and Bio-Melatonin 3mg tablets. Liquid formulations, usually 1mg in 1ml, are also more expensive, but may be of value in those with extreme swallowing difficulties, although Bio-Melatonin 3mg tablets can be crushed and dispersed in water etc.