Indication
Insomnia
RAG rating
Double Red
Document type
Decision document
Place
Hertfordshire and West Essex ICB
Output type
Pharmacy / Prescribing
Document
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Melatonin (Slenyto)

HERTFORDSHIRE AND WEST ESSEX AREA PRESCRIBING COMMITTEE (HWE APC)

Slenyto for the treatment of insomnia

DOUBLE RED

Not recommended for primary or secondary care prescribing

Name generic (trade) Melatonin 1mg and 5mg prolonged-release tablets (Slenyto®)

What it is Naturally occurring hormone produced by the pineal gland

Indication Treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient

Date decision last revised HMMC October 2020, WEMOPB December 2020

Decision status Final

NICE / SMC Guidance NICE – no Guidance, SMC – not recommended for use within NHSScotland, AWMSG – not recommended for use within NHS Wales

HWE APC recommendation

Recommendation (in line with East of England Priority Advisory Committee recommendations):

  • Commissioning of melatonin (Slenyto®) for the treatment of insomnia in children and adolescents aged two to 18 years with Autism Spectrum Disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient, is not recommended as the case for cost effectiveness has not been proven.
  • Off label use for any other indication is not recommended. 

ASSESSMENT AGAINST THE ETHICAL FRAMEWORK

Evidence of Clinical Effectiveness

See PAC guidance statement

Cost of treatment and Cost Effectiveness

See PAC guidance statement

The needs of the population

The needs of the population appear to be low as there is an alternative treatment (Circadin®) that is lower cost.

The needs of the community

The impact on the health economy is considered high as Slenyto® is higher cost than other alternative pharmacological therapies.

Equity and equality

Patients with neurodevelopmental disorders are considered to be disabled under the Equality Act 2010. Approval of the PAC recommendations for Slenyto® has a neutral impact on patients as alternative pharmacological therapies are available. There is no differential impact expected on one or more equality groups differently to others Age; Disability; Gender reassignment; Marriage & Civil Partnership; Pregnancy & Maternity; Race; Religion & Belief; Sex; Sexual orientation.

Policy Drivers

Implementability

No issues identified. Approval of the PAC recommendations aligns with the Hertfordshire Melatonin Prescribing Support Document: Melatonin in Neurodevelopmental Disorders in patients under the age of 18 years.

References

See PAC guidance statement.

Version number
1.1
Developed by
HWE PMOT
Approved by
HMMC and WEMOPB
Date approved / updated
HMMC October 2020 and WEMOPB December 2020
Review date
This recommendation is based upon the evidence available at the time of publication. The recommendation will be reviewed upon request in the light of new evidence becoming available.
Superseded version
1.0 Adopted as part of harmonisation work across HWE
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