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. 

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:

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:

  1. significant sleep onset difficulties 
  2. 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.
  • Bisht V., Beach S. Melatonin-Audit of prescribing practice for children in a rural population. Archives of Disease in Childhood. 2014;99:A64.
  • British Medical Association, Royal Pharmaceutical Society of Great Britain, Royal College of Paediatrics and Child Health, Neonatal and Paediatric Pharmacists Group. BNF for Children 2014-2015. London: BMJ Group; 2014. [on line] available from: http://www.medicinescomplete.com/mc/bnfc/current/ accessed 29/12/2014.
  • 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.
  • Cecil V et al. Melatonin for treatment of sleeping disorders in children with ADHD: a preliminary open label study. European Journal of Pediatrics, 2003;162:554-555.
  • Cochrane Library 2009 issue 3, Melatonin for the prevention and treatment of jetlag (review).
  • De Leersnyder H, Zisapel N, Laudon M. Prolonged-release melatonin for children with neurodevelopmental disorders. Pediatr Neurol [Internet]. 2011 [cited 2011 Jul];45(1):23-6. In: Ovid MEDLINE(R) [Internet]. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=21723455.
  • ESUOM2: Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin Published: 04 January 2013 NICE: London [online] available from: http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESUOM2.jsp accessed 19/9/2013.
  • Gringas P. When to use drugs to help sleep. Archives of Disease of Childhood, 2008;93:976-981.
  • Hoebert M et al. Long term follow up of melatonin treatment in children with ADHD and chronic sleep onset insomnia. Journal of Pineal Research, Aug 2009;47(1):1-7.
  • Jain S., Horn P., Simakajornboon N., Holland K., Glauser T.  Melatonin improves sleep in children with epilepsy: Results from a randomized, double-blind, placebo-controlled, cross-over study. Epilepsy Currents. 2014;14:442.
  • Jeraisy Majed DM Ba Armah A.L., Al Bekairy A., Mohiuddin B., Altwaijry W.  Effect of melatonin in neuro-developmentally disabled children with sleep disorders. Canadian Journal of Neurological Sciences. 2014;41:S21-S22.
  • London New Drugs Group Briefing – Melatonin in paediatric sleep disorders Sept 2008.
  • M Smits et al. Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: A randomized placebo controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, Nov 2003; 42(11):1286-1293.
  • Montgomery P et al. The relative efficacy of two brief treatments for sleep problems in young learning disabled children: a randomised controlled trial. Archives of Disease in Childhood, 2004; 89:125-130.
  • Owens J. Pharmacotherapy of paediatric insomnia. Journal of the American Academy of Child and Adolescent Psychiatry, Feb 2009;48(2):99-107.
  • QIS Evidence Note 14 – Melatonin to assist in the management of sleep disorders in children with neurodevelopmental disorders Dec 2006.
  • Ross C et al. Melatonin treatment for sleep disorders in children with neurodevelopmental disorders: an observational study. Developmental Medicine and Child Neurology’ 2002; 44:339-344.
  • Sweis D. The Uses of Melatonin. Archives of Disease in Childhood, 2005; 90:74-77.
  • Stores G. Medication for sleep-wake disorders. Archives of Disease in Childhood, 2003; 88:899-903.
  • T Shah et al. Administration of melatonin mixed with soft food and liquids for children with neurodevelopmental difficulties. Developmental Medicine and Child Neurology 2008, 50: 845-849.
  • Therapeutic Research Faculty. Melatonin. Natural Medicines Comprehensive Database, 2004.
  • van Geijlswijk IM, Mol RH, Egberts TC, Smits MG. Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia. Psychopharmacology (Berl) [Internet]. 2011 [cited 2011 Jul];216(1):111-20. In: Ovid MEDLINE(R) [Internet]. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=medl&NEWS=N&AN=21340475.
Appendix 1: Leaflet for parents - sleep diary
Appendix 2: Sleep diary
Appendix 3: Good advice on sleeping for primary age children
Appendix 4: Tips on helping secondary age children sleep
Appendix 5: Melatonin for sleep disorders in children and adolescents (information for patients and carers)
Editorial Information

Last reviewed: 31 October 2020

Next review: 31 October 2021

Author(s): Melatonin Working Group

Version: 6

Co-Author(s): Patricia Hannam

Approved By: TAM subgroup of the ADTC

Reviewer Name(s): Sheila Watt

Document Id: TAM288