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 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.
- See Appendix 3: Good advice on sleeping for primary age children
- See Appendix 4 Tips on helping secondary age children sleep
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.
- See Appendix 1: Sleep Diary: Leaflet for parents
- See Appendix 2: Sleep Diary
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:
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: https://yellowcard.mhra.gov.uk/
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
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.
Route of administration
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
Stop melatonin for 1 week during a non-stressful period; repeat the sleep diary and review.
Behavioural measures and sleep diaries.
Indefinite if significant sleep problem persists and patient continues to benefit.
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.