Referral for Initiation of Melatonin (South Warwickshire)

Contact:

Department of Paediatrics Warwick Hospital Lakin Road Warwick CV34 5BW

Tel: 01926 495321

Email: swg-tr.paediatric.secretaries@nhs.net

Please attach the completed form to all new referrals for consideration of Melatonin ensuring they meet the following criteria:

Inclusion Criteria

Melatonin for Insomnia – Paediatric Prescribing Support Information for Primary Care

Scope:

This information is used to support prescribers in managing patients who have been initiated on melatonin by a specialist for the management of persistent chronic sleep disorder

Melatonin has been considered as appropriate for prescribing in Primary Care and the information contained in this document has been provided to support you to prescribe the medicine

Your patient has been identified as being suitable to receive melatonin in accordance with the indications detailed below

They have been started on treatment and have been reviewed to assess the efficacy and adverse effects of the treatment by the specialist team

Your patient’s dose is now stable and is detailed in the clinic letter and Specialist Initiated Drug Checklist (SIDC)

Prescribing information:

Please refer to Specialist Initiation Drug Checklist (SIDC) statements for the relevant formulations

These can be found on the Area Prescribing Committee netFormulary for Coventry and Warwickshire

Primary Care Review Guidance:

Monitoring:

• Monitor sleep and suitability to continue melatonin every 6 months
• Review longest sleep episode and sleep latency
• Use of a sleep diary may be suggested to assist with this on an annual basis for one week
• No blood monitoring is required
• General observation of these children is recommended

Drug Holidays – This can be considered prior to routine review on an annual basis

Treatment breaks can be abrupt and a two-week cessation period prior to review date may be considered

Use of a sleep diary for a week whilst on medication and for a week without medication may assist with objective review

Clinical reflection from The National Child and Adolescent Learning Disability Psychiatry Network suggests that the efficacy may be lost if melatonin is prescribed for longer than two years

It suggests that if the melatonin is withdrawn prior to this, sensitivity may be re-established, and melatonin successfully re-introduced at a lower dose

If sleep improvements are maintained without melatonin, therapy can be stopped. If sleep deteriorates and continues to be an issue, the original dose where sleep improved can be re-instated

Ongoing drug holidays can be considered at review

If there is a consistent correlation of sleep deterioration at drug holiday, patients should be advised to continue without break

How long the melatonin should be prescribed for?

The duration of treatment benefit may vary between individuals

Treatment with melatonin should be continued only when considered to be beneficial

If the patient appears to be gaining no benefit from melatonin, treatment should be stopped

Information from drug holidays should be considered as this allows comparison and highlights impact of melatonin pharmacotherapy

At least six months of clinical benefit should elapse before considering withdrawal

Withdrawal periods from therapy

For patients who have had established clinical benefits and wish to withdraw from therapy, or where there is a superseding clinical rational, withdrawal may be considered

It is suggested withdrawal may occur over a period of 3-4 weeks

However, for some children if withdrawal is not successful treatment may be necessary long term

Other resources:

Loughborough daily sleep diary and a fact sheet with patient guidance regarding improved sleep hygiene

Sleep resources for children and their families – The Cerebra website cerebra.org.uk is a useful resource for families and offers advice regarding sleep related issues in young people