North East and North Cumbria
ICS Formulary
 
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4 Central nervous system
04-01-01 Hypnotics

Melatonin
Formulary
  • First line: melatonin 1mg and 5mg modified release tablets in line with licensed indications only.
  • Second line: melatonin 1mg, 2mg, 3mg, 4mg and 5mg tablets (crushed if necessary).
  • Third line: melatonin 1mg/1ml oral solution - 1st choice for patients unable to tolerate solid dose formulations. Consilient Health formulation to be used as it is alcohol and propylene glycol free

Approved Indications

Melatonin can be used to facilitate the induction of sleep, and increase the duration of sleep on the advice of an appropriate secondary care specialist, in the following situations:

1) Visually impaired or blind people with disturbed sleep wake cycles. Green plus
2) Delayed sleep phase syndrome and other circadian rhythm disorders.Green plus
3) Children with neurological or behavioural disorders including: Amber

  • Attention deficit hyperactivity disorder (ADHD).*
  • Chronic sleep onset insomnia.*
  • Neurodevelopmental disabilities (e.g. involving delayed brain maturation, sensory dysfunction - especially visual and dysfunction of sleep centres).*

4) Treatment of children and young adults with chronic fatigue syndrome / myalgic encephalomyelitis who have sleep difficulties (as recommended in NICE clinical guideline no. 53).* Amber
5) Prior to examinations such as a sleep encephalogram (EEG) in children and sedation prior to scans in paediatric oncology. Green plus
6) Patients with REM sleep behaviour disorder (RBD) - e.g. associated with degenerative conditions such as Parkinson’s disease or dementia, as a second line treatment to clonazepam. Green plus
7) To improve nocturnal sleep in critically ill patients (to aid weaning from mechanical ventilation) Green plus

*Note that for indications 3 and 4 in children and young people melatonin is classified as an ‘amber’ drug and therefore subject to formal shared care guidance.  Please follow relevant link below for the most recent guideline.

Link  Tees, Esk and Wear - Melatonin Shared Care Guideline
Link  North of Tyne, Gateshead and North Cumbria - Melatonin for the management of Sleep – Wake Disorders in Children and Young People
Link  North of Tyne, Gateshead and North Cumbria - Melatonin Deprescribing Guideline (March 2022)

View adult BNF  View SPC online  View childrens BNF