Melatonin prescribing

Licensed melatonin

Circadin® (prolonged-release melatonin 2mg tablet) is the only licenced formulation of melatonin in the UK, licensed for short-term treatment (up to 13 weeks) of primary insomnia characterised by poor quality of sleep in patients aged 55 or over19.

Unlicensed use of melatonin

However, in October 2014, 31 different formulations of melatonin were recorded as being supplied in primary care in England59; much of which are imported formulations of capsules, tablets, and liquids36. As a result, the unlicensed and/or off-label use of melatonin is common in the UK, including4280:

  • the prescribing of the many unlicensed formulations of melatonin available in the UK;
  • melatonin’s use in unlicensed indications including treatment of sleep disturbance in children adolescents, post-head injury, rapid eye movement sleep behavioural disorder and sleep phase disorders.

Guidance

When choosing between melatonin formulations, a healthcare professional should consider relevant guidance, their professional responsibilities and the cost implications. In particular, the GMC26 and MHRA47 advise that an unlicensed product should not be used where a product available and licensed within the UK could be used to meet the patient's need.

UK guidance on the choice of melatonin

  • MHRA Drug procurement advice48

    • Before June 2008, melatonin was only available in the UK in unlicensed medicinal products, many of which were non-pharmaceutical grade products imported from the United States of America, where melatonin products are classed as supplements, not medicines. These products are not required to be manufactured to the standards of Good Manufacturing Practice normal for pharmaceuticals. It is therefore important to ensure that the licensed product available in the UK is used wherever possible. This includes off-label use of the licensed product, if deemed suitable by the clinician.
  • MTRAC56

    • Commissioners may wish to bear the following in mind when considering the commissioning of melatonin:
      MHRA advise that “it is important to ensure that the licensed product available in the UK is used wherever possible. This includes off-label use of the licensed product, if deemed suitable by the clinician.”
  • London Procurement Partnership42

    • Circadin® should be first-choice for any new initiations of melatonin, and consideration should be given to switching existing patients to Circadin®, following review of treatment.
    • All other formulations of melatonin are unlicensed, may vary in availability and quality and are significantly more expensive than Circadin®.

Whilst there will be instances whereby alternative formulations of melatonin will be considered the most appropriate for selected patients (eg. liquid formulations for patients with swallowing difficulties), there is little evidence to support the use of unlicensed solid-dose formulations as research indicates that there is no dose–response relationship with melatonin4493.

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