Sleep pathway (Paediatric Guidelines)

TAM (Treatments and Medicines) NHS Highland
NHS Highland

Audience

  • Highland HSCP only
  • Community Paediatrics and Primary Care
  • Children only

The aim of this sleep pathway is to provide a guide for professionals considering a referral of a child or young person (CYP) with sleep difficulties to community paediatrics. The pathway is to encourage a standardised approach across all settings in CYP services in Highland.

Introduction

Sleep problems are common in CYPs. Although behavioural and environmental factors are the most common causes for sleep problems, there may be an underlying medical problem that needs to be assessed and managed by appropriate professionals.

CYPs with neurological and neurodevelopmental condition(s) are particularly prone to experience sleep problems. Their presentation is often complex and cause could be multi-factorial, including neurobiological alterations, such as delayed brain maturation, altered function of sensory organs, especially vision, altered pattern of normal sleep cycle, and inadequate or irregularities with the production of melatonin, which is a natural sleep hormone produced by the pineal gland in the brain.

Sleep problem terms

  • Delayed sleep onset (sleep latency).
  • Frequent night time waking, day-night reversal pattern, early morning wakening: these could be due to behavioural / social factors and therefore good sleep hygiene and behavioural management are recommended to support CYP.
  • Parasomnias such as night terrors, nightmares and sleepwalking. These are common in CYPs and may consist of abnormal movements, behaviours, emotions, and autonomic activity during transitions between sleep states, from sleep to wakefulness or during arousals from sleep.
    Causes could be obstructive sleep apnoea (which will need assessment by ENT), or sleep deprivation, stress and anxiety, or substance misuse (which require good sleep hygiene, behavioural management and referral to appropriate services for support).

Hours of sleep needed by children of different ages
Age Hours of sleep
Babies 4 to 12 months old 12 to 16 hours including naps
Toddlers 1 to 2 years old 11 to 14 hours including naps
Children 3 to 5 years old 10 to 13 hours including naps
Children 6 to 12 years old 9 to 12 hours
Teenagers 13 to 18 years old 8 to 10 hours

Quick reference guide

Sleep problem(s) identified or reported:

If a medical problem (not including developmental issues) is causing sleep difficulties: 

Refer to appropriate professional. 

  1. Itching from eczema:
    Manage in Primary Care or refer to Hospital Paediatrics, as appropriate.
  2. Childhood medical illnesses: constipation, skin problems such as eczema, asthmatic symptoms, night time itchiness from allergies, gastroesophageal reflux, possible seizures, suspected iron deficiency:
    Manage in Primary Care.
  3. Sleep disordered breathing (loud snoring, choking or periodic stopping of breathing during sleep):
    Refer to ENT / Hospital Paediatrics.
  4. Medications that affect sleep:
    Discuss with prescribing professional.
  5. Anxiety:
    Discuss with lead professional / named person to plan support and onward referral to appropriate professional.

OR

If NO medical problem:

Refer to Universal Services (ie Health Visitor, Early Years Practitioner, School Nursing team or Learning Disability nurse) for intervention, including an assessment and support with sleep hygiene and behavioural strategies.

Assessment includes: CYP’s environmental factors such as lack of routine, over stimulating bedroom, bedroom temperature, bedding, comfort, noise, sharing bedroom with other children and nocturnal enuresis. Assessment also includes parental physical and mental health problems.

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If the intervention worked well, ensure sleep hygiene measures and behavioural interventions are continued.

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If the intervention did NOT work, ensure the guidance and advice is being followed by the CYP and the family. These interventions may require a long period of adherence before benefit is seen, occasionally they can be ineffective.

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If sleep problem continues:

Despite 3 months of consistent and active work on sleep hygiene and behavioural interventions:

Consider referral to Community Paediatrics as per referral criteria

Referral criteria

The following needs to have happened prior to any sleep referral being considered:

  • 3 months of consistent and active work with CYP and their family on sleep hygiene & behavioural interventions by Universal Services, such as Health Visitor / Early Years Practitioner / School Nurse / Learning Disability Nurse.

Community Paediatrics ONLY accept sleep referrals for CYPs with either of the following:

  • Neurological condition, includes significant visual impairment.
  • Diagnosed neurodevelopmental condition(s).
  • CYPs who are on the NDAS (Neurodevelopmental Assessment Service) waiting list for an assessment for possible neurodevelopmental condition(s).

The following are to be provided with the sleep referral:

  • Completed sleep referral form (NHS Highland intranet access required).
  • Written evidence of which strategies did and did not work.
  • Sleep diary (NHS Highland intranet access required) completed by the CYP and family, over 2 weeks minimum, during a typical period for the CYP. For example, during school term.

Management in Community Paediatrics

If obstructive sleep apnoea or any other medical problem identified at triage or following an assessment in Community Paediatrics, a referral will be re-directed or CYP will be referred to appropriate service, such as ENT or Paediatric Respiratory.

If no medical problem is identified following an assessment in community paediatrics, sleep medication may be considered ONLY for delayed sleep onset (sleep latency) for CYPs with neurological or neurodevelopmental condition.

Medication

We do not recommend sedatives or hypnotics for sleep difficulties. If these are necessary for certain circumstances, they are only to be used for a 1 to 2-week period.

SIGN and NICE guidelines recommend that a trial of melatonin should ONLY be considered in: Children with neurodevelopmental condition(s) whose sleep difficulty has not resolved following behavioural interventions AND that melatonin should be used in combination with behavioural interventions.

  • NICE states that evidence for use of melatonin has shown a total increase in sleep time of only 20 minutes and a 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.
  • Melatonin is recommended for short term use only.

If CYP meets sleep referral acceptance criteria, and are accepted to Community Paediatrics, we may consider melatonin treatment for short term use, if the sleep problem is delayed onset of sleep.

  • Melatonin is NOT recommended for the management of sleep difficulties in neurotypical children.
  • Melatonin is NOT indicated for other types of sleep difficulties, such as frequent night time waking and early morning waking.

Melatonin prescribing options

First line: Melatonin 3mg tablets: Specialist recommendation only

  • This is the most cost-effective option.
  • These tablets are licensed for: Insomnia in children and adolescents aged 6 to 17 years with ADHD, where sleep hygiene measures have been insufficient.

Adjunctive treatment:

  • Continue behavioural measures and sleep hygiene measures provided by Universal Services.

Administration: 

  • Give 30 minutes before bedtime, preferably on an empty stomach, if possible.
  • Melatonin can take up to an hour to be effective.
  • Tablets can be crushed and given in soft food or a small drink for patients who are unable to swallow whole tablets.

Recommended dosing regimen: 

  1. Initial trial: 7 to 14 days: 3mg tablet daily
  2. Assess response and adjust dose.
    • No response (delayed time to sleep onset): increase to 6mg and then to 9mg, if necessary.
    • Good response: Stabilise the patient on therapy.
  3. Maximum dose = 9mg. Extra benefits of doses above 9mg are uncertain.
  4. Supply medicine for one further month after the dose has stabilised. Then review.
  5. Encourage drug-free holidays for 7 to 10 days during a non-stressful period. If necessary then re-start with 3mg and increase as per response.
  6. Treatment duration: To continue while significant sleep problem persists and patient continues to benefit.
  7. Discontinuation: Discontinue melatonin if ineffective or adverse drug reactions.
  8. Withdrawal of melatonin can be immediate. Provide necessary support when drug is discontinued: Behavioural measures and sleep hygiene measures provided by Universal Services are to be continued.

If any other sleep difficulties identified, consider a referral to appropriate professionals.

Swallowing difficulties:

Tablets can be crushed and given in soft food or a small drink for patients who are unable to swallow whole tablets.

For those patients who are unable to tolerate the tablet formulation, even with the advice of crushing the tablet, the patient is to be referred back to the Specialist Service for advice and recommendation on alternative, non-formulary options. 

Alternative, non-formulary options

Melatonin liquid: Specialist recommendation only

  • NOTE: This formulation is considerably more expensive than the tablets.
  • It should only be used in exceptional circumstances, eg in patients with enteral feeding tubes. 
  • Licensed for delayed sleep wake phase disorder & for insomnia with ADHD in children and adolescents aged 6 to 17 years, where sleep hygiene measures have been insufficient.
  • Off-label use in children under 6.
  • Different formulations may contain different excipients (eg, benzyl alcohol and polyethylene glycol) that may cause side effects, particularly in those under 6 years, and interact with other medicines. 

Melatonin 10mg capsules: Specialist recommendation only

  • This may be suitable for patients who are not able to tolerate 3 x 3mg tablets. 
  • Unlicensed.

Modified-release melatonin: Specialist recommendation only

  • This may be considered for those patients who wake throughout the night. This may be used alongside normal release melatonin. NB: The evidence base for this is poor.  
  • Off-label indication.
  • Please ensure that the patient / carer is aware that modified release formulations cannot be crushed.  

Clonidine: Specialist use only

If melatonin is not effective, not tolerated or is not sufficient for a CYP who has a neurological or neurodevelopmental condition, clonidine may be considered. This is an off-label indication. Note: this may be taken alongside melatonin.

This will be managed by the specialist service as below: 

  • Dose: 25 to 150 micrograms
  • Review at 4 weeks at Specialist Clinic: Patient and parent report on the duration taken for sleep augmentation.
  • If tolerated: ongoing prescriptions with close monitoring, including blood pressure, every 4 to 6 months or sooner. 

For full prescribing information, see: BNFC and SPC.

Comment re medicine licence status

MHRA advises that a licensed preparation should be considered first, even if it is for an off-label use, as the manufacturing quality is assured.

In line with the guidance from the General Medical Council (GMC), it is the responsibility of the prescriber to determine the clinical need of the patient and the suitability of using melatonin outside its authorised indications, or using an unlicensed formulation.

Responsibilities

Specialist Service responsibilities

  • Obtain informed consent prior to therapy, no need for written consent.
  • Provide an understanding of potential side-effects and the requirement for monitoring, to the patient and the patient’s parents / carers.
  • Prescribe melatonin until the patient is on a maintenance dose, when prescribing responsibilities can be transferred to Primary Care. 
  • If an unlicensed medicine is used, or a medicine is used off-label, the implications of this is explained to the patient / carer.
  • When a non-formulary medicine has been recommended
    • The non-formulary request to primary care is completed in full, including the reason why a non-formulary medicine is chosen.
    • That this decision is reviewed at each opportunity to see if a formulary option would be appropriate for future care.  
  • Discuss patient / carer responsibilities with them:
    • Ensure that behavioural and sleep hygiene measures are continued, even when medication is being taken, and after it has been discontinued.
    • Ensure compliance with medication.
    • To attend hospital clinic and GP appointments. Note: failure to attend appointments will result in melatonin treatment being stopped.
    • To report adverse effects to their doctor.
  • Review:
    • Initially at 3 months, then at least yearly in the longer term, or sooner, if any concern.
    • Assess and monitor the patient’s response to treatment.
    • Monitor patient parameters and check for possible complications, eg: 
      • Monitor height, weight and the onset of puberty / sexual development, particularly in children taking long-term melatonin.
      • Blood pressure if on clonidine.
    • Consider discontinuation of medication, when appropriate. 

Primary Care responsibilities

  • Primary care clinician prescribes melatonin as per Specialist’s guidance and contacts Specialist clinician if any concern.
    Please note, as per below, that patients must continue to engage with the Specialist Service for melatonin prescriptions to continue. 

Shared responsibilities

  • Ensure behavioural and sleep hygiene measures are ongoing.
  • Any adverse drug reaction/side effect should be reported by using Yellow Card Scheme.

Transfer to adult services

When CYPs with neurological and neurodevelopmental conditions leave school and they are still taking sleep medications, the specialist team will do an end of treatment review before transferring care to Primary Care or adult specialist services, as appropriate.

Further information for Health Care Professionals

This guideline has been produced based on recommendations and information on General Medical Council (GMC), National Institute for Health and Care Excellence (NICE), The Scottish Intercollegiate Guidelines Network (SIGN), Highland Formulary, British National Formulary for children (BNFc) and The Medicines and Healthcare products Regulatory Agency (MHRA).

Patient information

National resources:

NHS Highland resources: 

Other resources:

For young people: 

For families with disabled children:

Abbreviations

  • CYP – Children and Young Person
  • BNFc – British National Formulary for Children
  • NDAS – Neurodevelopmental Assessment Service
  • ENT - Ear, Nose and Throat

Editorial Information

Last reviewed: 05/12/2024

Next review date: 31/12/2027

Author(s): Community Paediatrics, Children’s services.

Version: 7.1

Approved By: TAMSG of the ADTC

Reviewer name(s): Dr S Gallella, Consultant Community Paediatrician.

Document Id: TAM288