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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 4 - Central nervous system 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
04.01.01 Hypnotics
BLMK Melatonin Prescribing Support Information – For use in Children & Young People MHRA Drug Safety: Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression (March 2020) NICE CG112: Sedation guidelines in children and young people (NICE 2010) NICE TA77: Insomnia - newer hypnotic drugs RCGP Top Tips for Dependence Forming Medications (2019) RCGP Top Tips for Dependence Forming Medications (2019)

Melatonin tablets (Adaflex®)

Amber SPIS
Restricted Drug Restricted

Available as 1mg, 2mg, 3mg, 4mg and 5mg

Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient (licensed)

The tablet is also licensed to be crushed and mixed with water directly before the administration.

Entry reviewed: December 2024

BNF BNFc SPC
Melatonin Prescribing Support Information – For use in Children & Young People

Melatonin 2mg modified release (m/r) tablets
(Adult use - REM sleep disorder in Parkinson's disease)

Amber SPIS
Formulary

 

Prescribe generically.

 

Entry reviewed: October 2025

BNF BNFc SPC

Melatonin 2mg modified release (m/r) tablets
(Oral)

Amber SPIS
Restricted Drug Restricted

unlicensedUNLICENSED for ADHD

Use in children and adolescents is off-label.

The decision to use m/r tablets will be made by the specialist and is determined by the child’s sleep profile, usually if there are problems with sleep duration e.g. frequent night waking or disrupted sleep.

 

Entry reviewed: October 2025

BNF BNFc SPC
Melatonin Prescribing Support Information – For use in Children & Young People

Melatonin 1mg/mL oral liquid (Ceyesto®)

Amber SPIS
Restricted Drug Restricted

Licensed for: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient.

For use in patients where crushing and mixing of Adaflex® with water directly before administration is not suitable.

Please prescribe by brand name; Ceyesto is a licensed product.

 

Entry reviewed: December 2024

BNF BNFc SPC
Melatonin Prescribing Support Information – For use in Children & Young People

Melatonin 3mg immediate release tablets (Ceyesto®)

Amber SPIS
Restricted Drug Restricted

Licensed for: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient.

Melatonin 3mg immediate release tablets (ceyesto®) are an additional option for paediatric and adolescent patients requiring melatonin:

  • who require an immediate release melatonin product
  • who can swallow tablets and are already prescribed an immediate release melatonin product
  • who are on doses of 3mg, 6mg or 9mg daily

    Entry reviewed: December 2024

BNF BNFc SPC
Melatonin Prescribing Support Information – For use in Children & Young People
Non formulary items

Melatonin liquids (Kidmel, Colonis brands)

 
Non Formulary

 

Colonis and Kidmel have been removed from the Formulary following release of Ceyesto Liquid (licensed product) - see Ceyesto monograph.

The ICB acknowledge there may be a minority of cases where switch is not possible - these patients may remain on their usual medication where the reason is clearly documented in the clinic letter.

 

Entry reviewed: November 2023

BNF BNFc SPC

Melatonin (Slenyto®) (Oral)

DNP
Non Formulary

1mg and 5mg prolonged release tablets.

JPC did not approve use (September 2020) due to lack of cost effectiveness data.

 

BNF BNFc SPC
04.01.01 Benzodiazepines
04.01.01 Zaleplon, Zolpidem and Zopiclone
04.01.01 Chloral and derivatives
04.01.01 Clomethiazole (Chlormethiazole)
04.01.01 Antihistamines
04.01.01 Alcohol
04.01.01 Sodium oxybate
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.