• 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. 
2) Delayed sleep phase syndrome and other circadian rhythm disorders.
3) Children with neurological or behavioural disorders including: 

• 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).* 
5) Prior to examinations such as a sleep encephalogram (EEG) in children and sedation prior to scans in paediatric oncology. 
6) Patients with injurious parasomnia including REM sleep behaviour disorder (RBD) – e.g associated with degenerative conditions such as Parkinson’s disease or dementia, as an alternative to clonazepam.
7) To improve nocturnal sleep in critically ill patients (to aid weaning from mechanical ventilation) 

*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.

• To be used in accordance with NICE criteria

• Alcohol withdrawal - chlordiazepoxide is preferred in the management of alcohol withdrawal.

• 25mg and 50mg tablets
• Approved for the treatment of long-term insomnia in line with NICE via NHS Sleep Clinics at
  • Northumbria Healthcare NHS Foundation Trust;
  • South Tees Hosptials NHS Foundation Trust; and 
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • First 3 months supply from secondary care with a review at 3 months. If effective, transfer to primary care with a further 1 month supply from secondary care to allow for handover

• Approved for the treatment of narcolepsy with cataplexy in children age 7 years and above only in accordance with NHS England clinical commissioning policy.
•  The Northern (NHS) Treatment Advisory Group recommends the use of sodium oxybate in adult patients who have received and benefited from treatment with sodium oxybate as commissioned by NHS England. i.e. continuing treatment for those >19 years old.
• The Northern (NHS) Treatment Advisory Group also recommends sodium oxybate for use in adults who have not received it as a child as per the RMOC criteria, noting that may sometimes be used in combination with other agents.
• The following criteria for use in adults who have not received sodium oxybate as child apply:
• Patients presenting with narcolepsy with cataplexy according to International Classification of sleep disorders 3 (ICSD) criteria for Narcolepsy Type 1 AND
• Patients ≥ 19 years old AND
• Where patients have co-morbidities, which are also affecting sleep, these should be managed and adequately treated (for example moderate to severe obstructive sleep apnoea or restless legs syndrome) AND
• Failure to respond to non-pharmacological treatments consisting of behavioural and environmental adaptations, for example planned naps AND
• Inadequate response (within 3 months) to, or intolerable adverse effects from, or contra-indicated use of, more than one stimulant for narcolepsy, and more than one anticataplectic agent AND
• Assessed as being able to benefit from sodium oxybate via a specialist sleep centre.
• Sodium oxybate is generally considered as a final treatment option for patient