UNLICENCED PRODUCT
MELATONIN

For the treatment of paediatric sleep disorders

Indications:

Treatment of paediatric sleep disorders.

Clinical Evidence:

There are no published controlled trials with melatonin for the treatment of paediatric sleep disorders. Data on the efficacy and safety of melatonin are limited chiefly to case reports and reviews involving around 150 children.

Children studied ranged from 3 months to 23 years old and had severe sleep disorders which had failed to respond to conventional management, including strict bedtime scheduling and sedatives. These children were also mentally retarded, visually impaired, multiply disabled, neurologically disabled or suffered with a combination of these disabilities. Melatonin was administered at doses generally between 0.5 – 10mg before the desired bedtime.

Response to melatonin was largely assessed using sleep diaries and carers observations, with no standardisation against pre-defined criteria. Overall the data suggest a good subjective response to melatonin given at bedtime (77-86%). Randomised controlled trials need to be performed to fully evaluate the use of melatonin in this patient population.

Safety:

The limited clinical data suggest that melatonin is well tolerated in children. Adverse events that have been reported include a potential effect on seizure frequency in patients with epilepsy.

In general reviews of melatonin treatment in adults and children the most commonly documented side effects included reductions in body temperature, sedation, headache, depression, tachycardia and pruritis. There are no published safety data on the long term use of melatonin for any purpose.

• Melatonin is an unlicensed product. It is only available on prescription on a named patient basis. Such prescibing incurs increased clinical responsibility and liability on the prescriber for the efficacy, safety and the quality of the product.
• Melatonin was previously available as a nutritional supplement from health food shops and pharmacies. It was later withdrawn by the MCA because of concerns about its use as a medicinal product and a lack of evidence on its safety.

• The data available on the use of melatonin in children, relates specifically to its use in children with chronic sleep disorders associated with neurological disorders and/or visual impairment.

• At current prices the cost of one year’s treatment with melatonin capsules 5mg at bedtime is £368 or £51 with the 3mg tablets. Given the lack of evidence, no conclusions on the cost-effectiveness of treatment with melatonin can be made.

The decision of the committee is based on the published information available at the time the drug was considered.

The Committee’s decision remains open to review in the event of significant new evidence emerging.

A summary sheet with more detailed information can be obtained from MTRAC at the Department of Medicines Management, Keele University, Keele, Staffordshire ST5 5BG Tel: 01782 584203 FAX: 01782 713586

© MTRAC, Department of Medicines Management