Sleep onset difficulties

What's New

There are now a number of licensed melatonin products, however no melatonin product is licensed for the treatment of sleep onset difficulties in children. Melatonin 3mg tablets have been added to the NHS Highland Formulary as a clinically effective and cost-effective treatment for sleep onset difficulties in children (off-label indication). No other melatonin products are recommended.

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Presentation

Sleep disorders in children with neurological and neurodevelopmental disorders are very common.
Causes include:

delayed brain maturation
altered function of sensory organs, especially vision
abnormalities of the sleep centres.

The particular types of sleep difficulties seen include:

delayed sleep onset
frequent wakening
early morning wakening
day-night reversal patterns.

Referral

Initial referral:
GPs, Community Paediatricians or Child Psychiatrists who have patients with a sleep onset difficulty must, in the first instance, refer the patient to a Health Visitor, School Nurse or Community Nurse, in order that behavioural measures, good sleep hygiene and sleep diaries may be introduced.
See the Sleep Diary and www.sleepscotland.org

Treatment failure onward referral:
Refer to Sleep Councillor for advice, where this is available.

Management

It is well known that improving sleep patterns leads to a general improvement in health, behaviour and wellbeing.

Drug therapy may only be commenced AFTER behavioural interventions and sleep hygiene measures have been carried out.

Behavioural measures

Behavioural modification and appropriate sleep hygiene measures may require a long period of adherence before benefit is seen and occasionally they are ineffective.

Advice about sleep hygiene should be discussed with the family, backed up with written information (Appendices 3 and 4), and in consultation with the Health Visitor, School Nurse, Community Children’s Nurse or Community Nurse for Learning Disabilities, as appropriate.

If melatonin is being considered, behavioural measures MUST be used first and maintained during the trial. The benefits of behaviour change continue longer over time than drugs.

Appendices

See Appendix 3: Good advice on sleeping for primary age children
See Appendix 4 Tips on helping secondary age children sleep

Sleep diary

Detailed sleep histories are key to the diagnosis of sleep disorders, which can be a major source of stress for the whole family and limited solutions are available.

Sleep diaries and parent information are vital.
A baseline sleep diary should be completed to aid diagnosis of the type of sleep disorder (Appendix 1 and 2) prior to any trial of melatonin.
Further diaries are used to monitor effectiveness and influence decision making. Some children may have noticeable improvement in their sleep pattern after the first dose of melatonin. Others may not show improvement for several days or even weeks.
Assess and diagnose children with sleep onset difficulties and their suitability for treatment.
Ensure behavioural measures and sleep diaries have been followed and are ongoing.

Appendices

See Appendix 1: Sleep Diary: Leaflet for parents
See Appendix 2: Sleep Diary

Melatonin

Melatonin may be viewed as an alternative to sedatives and hypnotics, which have adverse side-effects. It may be prescribed to assist development of improved sleep patterns and behaviours, ONLY WHEN, appropriate behavioural sleep interventions fail.

NICE state that evidence for use of melatonin has shown a total increase in sleep time of only 20 minutes and reduction in time taken to fall asleep of approximately 20 minutes. There are still ongoing concerns over the lack of long-term safety data in children, and there is uncertainty as to the effect on other circadian rhythms including endocrine or reproductive hormone secretion.

For information on side effects, cautions and contra-indications see:

BNFC
emc

Any serious reaction should be reported to the Commission of Human Medicines (CHM) by whomever they are highlighted to. Use the Yellow Card System to report adverse drug reactions, see: www.mhra.gov.uk/yellowcard.

Any child being considered for a trial of melatonin MUST have:

significant sleep onset difficulties
AND at least one of the following:
- ocular visual impairment
- severe to profound learning disabilities
- neurological disorder, eg cerebral palsy
- neurodevelopmental disorder, eg attention deficit hyperactivity disorder (ADHD) and autism.

NHS Highland recommends:

Melatonin 3mg tablets are a clinical and cost-effective option.

The Pharma Nord brand is cost-effective; the tablets can be crushed and given in a small drink or soft food for patients with swallowing difficulties.
Other melatonin products are not recommended. See: NHS Highland Formulary

Medicine status:

Melatonin 3mg tablets are licensed in the UK for short-term use for Jet lag in adults (this is not a formulary indication).
Sleep onset difficuties in children is an off-label indication.

Dosing information
Route of administration	Oral In swallowing difficulties the tablets can be crushed and given in a small drink or soft food (Pharma Nord brand).
Initial trial: 7 to 14 days	3mg tablets daily Give 30 minutes before bedtime, preferably on an empty stomach. It can take up to an hour to be effective.
Assess response and adjust dose	If non response (delayed time to sleep onset, disturbed sleep, early morning awakening), increase to 6mg or 9mg (maximum dose). Extra benefits of doses above 9mg are uncertain.
Stabilise the patient on therapy	Supply medicine for one further month after the dose has stabilised
Review	Stop melatonin for 1 week during a non-stressful period; repeat the sleep diary and review.
Adjunctive treatment	Behavioural measures and sleep diaries.
Treatment duration	Indefinite if significant sleep problem persists and patient continues to benefit.
Discontinuation	Discontinue if ineffective. Provide necessary supervision and support during drug discontinuation phase. Withdrawal of melatonin can be immediate. Monitor for recurrence of sleep disorders, depending on the frequency of use.

Transfer from Paediatric to Adult Care

As this group of patients move into adult care, consideration should be given to continuation of their therapy. If therapy continues beyond children’s services, care should be transferred to young persons or adult services as appropriate. The principles in this guideline apply equally to this group of patients as they become adults.

Prescriber responsibilities - Primary Care

Ensure behavioural measures are ongoing.
Provide an understanding of potential side-effects and the requirement for monitoring to the patient and the patient’s parents.
Obtain informed consent prior to therapy.
Monitor height, weight, growth and the onset of puberty/sexual development, particularly in children during long-term administration.
Additionally, these should be monitored if melatonin is stopped.
Assess and monitor the patient’s response to treatment and check for possible complications.
Assess: initially, at 3 months, then 6-monthly in the longer term.

Patient / carer responsibilities

To attend hospital and GP clinic appointments.
Failure to attend appointments will result in medication being stopped.
To report adverse effects to their doctor.

Supporting documentation – references

Banta S. Use of melatonin in children and adolescents: clinician’s and parent’s perspective. Child and Adolescent Mental Health, May 2008;13(2):82-84.
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C Cummings; Canadian Paediatric Society Community Paediatrics Committee Melatonin for the management of sleep disorders in children and adolescents Paediatric Child Health 2012;17(6):331-3. Importing unlicensed medicines Important information relating to specific products Melatonin MHJRA: London [on line] available from: http://www.mhra.gov.uk/Howweregulate/Medicines/Importingandexportingmedicines/Importingunlicensedmedicines/ accessed 29/12/2014.
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Cochrane Library 2009 issue 3, Melatonin for the prevention and treatment of jetlag (review).
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London New Drugs Group Briefing – Melatonin in paediatric sleep disorders Sept 2008.
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