Melatonin

SHARED CARE PROTOCOL AND INFORMATION FOR GPs

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Melatonin clinical indication: for the treatment of sleep-wake cycle disorders in children.

Sleep disorders are common in children with neurological disorders, autism and visual impairment. These children often have disturbed sleep patterns, with delayed onset, fragmentation and frequent nocturnal awakening. Sleep disorders can be a major source of stress for the whole family and limited solutions are available. Behavioural modification and appropriate sleep hygiene measures are usually tried, but may be ineffective. Hypnotics and sedatives are generally effective initially but tolerance quickly develops and many cause unacceptable adverse effects. There is significant clinical experience with the use of Melatonin for the treatment of paediatric sleep-wake cycle disorders. Results in terms of improved sleep patterns have been generally favourable and adverse effects minimal.

As outlined in the NHS Circular 1992 (Gen 11) a consultant may seek the GPs involvement in prescribing for a patient where there is a Shared Care agreement. This leaflet provides information on Melatonin treatment guidelines for the shared care of therapy between the hospital consultant and GP concerned.

For use in children over three years of age with neurodevelopment disability, autism, visual impairment or neuropsychiatric disorders and chronic sleep disturbance where:

• Symptoms of sleep disturbance have been present for at least six months or sleep disturbance is so severe
  that the family are heading for crisis

• After failure of sleep hygiene improving measures e.g. a fixed bedtime routine.

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Recommended starting dose: 3mg given 20-30 minutes before desired sleep time. If there has been an insufficient response after 7-10 days, consider increasing dose to 6mg. In some cases a dose of 9mg may be tried although additional benefit of doses above 6mg is uncertain. For children who continue to have a fragmented sleep pattern after an initial two-week trial, consider using Sustained Release preparation. If child is unable to swallow capsules, they may be opened and the contents given with a small amount of food or liquid (if Sustained Release preparation the granules should not be crushed or chewed). The contents may be administered via a gastrostomy.

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In the UK Melatonin is classified as a medicine and is only available on a doctor's prescription. It is currently

unlicensed for use in the UK and is only available on a "named patient" basis.

The Melatonin used is synthetic.

Product used at Royal Hospital for Sick Children, Edinburgh -

Prolongevity- Life Extension USA (imported via IDIS World Medicines, Telephone 0208 410 0700)

3mg immediate release capsules, 3mg six-hour time-release capsules.

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Melatonin Shared Care Responsibilities

Aspects of care for which the Consultant Pediatrician and/or Psychiatrist is responsible:

• Assessing suitability of patients for treatment

• Initiation and supply of medicine for one further month after the dose has been stabilized, including
  conversion to sustained release preparation where appropriate

• Assess and monitor patient's response to treatment

• Liaison with GPs to agree to share the patient's care

• Report any suspected adverse events to the CSM.

• Discontinuation - advising the GP when a trial withdrawal of Melatonin should be undertaken.

Aspects of care for which the GP is responsible:

• Prescribing Melatonin once dose stabilized

• Liaison with the Consultant Pediatrician regarding any complications of treatment.

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Melatonin is generally well tolerated and no significant adverse effects have been reported with pharmacologically regulated Melatonin. Both increased and reduced seizure frequency has been reported in children with epilepsy.

Precautions and Contra-indications

It is contra-indicated in pregnancy due to unknown effects.

Should be used with caution in children with epilepsy, seizure frequency should be monitored.

None reported in the literature.

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