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 Formulary Chapter 4: Central nervous system - Full Chapter
04.01.01  Expand sub section  Hypnotics
 note  First line options include non-pharmacological approaches including introducing 'sleep hygiene' measures and advice on relaxation techniques.
Melatonin (Circadin®)
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Formulary
Amber 1

Tablet m/r
For treatment of severe sleep disorders in children - more information

 Green   for its licensed indication- as monotherapy for the short-term treatment (13 weeks) of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. 

 
Link  Melatonin Shared care Guideline
   
Melatonin (Slenyto®)
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Formulary
Amber 1

Tablet m/r

 Licensed for the treatment of insomnia in children and adolescents aged 2 to 18 years with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient - more information.

 
Link  Melatonin Shared care Guideline
   
Melatonin 10mg/5ml oral suspension (AF and SF)
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Formulary
Amber 1

Melatonin 10mg/5ml oral suspension (alcohol and sugar free) - unlicensed unlicensed

When writing a prescription for this formulation please add “Alcohol and Sugar Free” to the dose (e.g. 2.5ml ON, alcohol and sugar free) - more information

 
Link  Melatonin Shared care Guideline
   
04.01.01  Expand sub section  Benzodiazepines
Controlled Drug Temazepam
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Formulary
Green
Tablet, Oral solution
CD storage requirements apply within ULHT for ALL temazepam products
 
   
04.01.01  Expand sub section  Zaleplon, Zolpidem and Zopiclone
Zopiclone
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First Choice
Green
Tablet
Has potential to cause tolerance, dependence and withdrawal symptoms, and is liable to abuse.Licensed for short-term use only (4 weeks). Maximum daily dose (adults) is 7.5mg at night
Do not crush zopiclone tablets (they are difficult to crush, taste very bitter and the bioavailability may be affected)- more information
 
Zolpidem Tartrate
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Second Choice
Green

Tablet
2nd line to zopiclone if patients haven't responded or have experienced adverse effects
If needed tablet can be crushed and mixed with water - more information

 
Link  MHRA: Risk of drowsiness and reduced driving ability
Link  NICE TA77 Insomnia - newer hypnotic drugs
   
04.01.01  Expand sub section  Chloral and derivatives
Chloral Hydrate
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Restricted Drug Restricted
Red

Mixture and Solution - unlicensed unlicensed
For paediatric use only

 
   
04.01.01  Expand sub section  Clomethiazole (Chlormethiazole) to top
04.01.01  Expand sub section  Antihistamines
Promethazine Hydrochloride
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Formulary
Green
Tablet, Elixir 
   
04.01.01  Expand sub section  Alcohol
04.01.01  Expand sub section  Sodium oxybate
Sodium Oxybate  (Xyrem®)
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Formulary
Red
High Cost Medicine

Oral solution
NHS England will commission sodium oxybate for symptom control of narcolepsy with cataplexy (children) in accordance with the criteria outlined below.
Patients in secondary care should be referred to the designated tertiary service

 
Link  Clinical Commissioning Policy: Sodium oxybate for symptom control of narcolepsy with cataplexy
   
 ....
 Non Formulary Items
Clomethiazole  (Heminevrin®)

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Non Formulary
RedRed
Capsule
 
Cloral Betaine  (Welldorm®)

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Non Formulary
RedRed
 
Flurazepam  (Dalmane®)

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Non Formulary
RedRed
 
Loprazolam

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Non Formulary
RedRed
 
Melatonin  (Bio-melatonin)

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Non Formulary
RedRed

Tablet 3mg (Bio-melatonin) - unlicensed
Oral solution 2mg/5ml and 5mg/5ml - unlicensed

Bio-melatonin and other unlicensed melatonin tablets / capsules are no longer recommended where the patients fits the criteria for the licensed alternative preparation - more information

 

 

Link  Melatonin Shared Care Guideline.
Link  NICE ESUOM2 Sleep disorders in children and young people with attention deficit hyperactivity disorder: melatonin - 4 January 2013
 
Melatonin  (Colonis Pharma)

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Non Formulary
RedRed

Tablet 3mg and 1mg/1ml oral solution.

The safety and efficacy of both formulations in children and adolescents aged 0 – 18 years has not been established and should not be used in this age group - more information.

 
Melatonin  (Pharm Nord)

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Non Formulary
RedRed

Tablet 3mg

Short-term treatment of jet-lag in adults.

No formal assessment

 

 
Melatonin  (Syncrodin®)

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Non Formulary
RedRed

Tablet

- no formal assessment

 
Nitrazepam

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Non Formulary
RedRed
Tablet, Oral Suspension
 
Triclofos Sodium  (Triclofos® oral Solution BP (Triclofos Elixir))

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Non Formulary
RedRed
 
Zaleplon  (Sonata®)

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Non Formulary
RedRed
 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Amber 1

Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol. Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred.  

Amber 2

Medicines suitable to be prescribed in primary care after specialist recommendation or initiation  

Green

This will signify a product that is approved for initiation in either primary or secondary care within licensed indications. Specialist initiation and shared care guidelines are not considered necessary.  

Grey

Medicines restricted for use in those patients under the care of external trusts i.e - Peterborough and Stamford Hospitals NHS Foundation Trust or the Northern Lincolnshire and Goole NHS Foundation Trust  

Red

This will signify that a product has been approved for use within secondary or tertiary care, or by a primary care hosted specialist service only and should not be routinely prescribed in primary care. RED drugs may be used within ULHT or LPFT subject to approval for use within each trust. ULHT and LPFT reserve the right to determine whether or not RED drugs will be used within their trusts. RED classification does not automatically signify that a drug will be available within secondary/tertiary care.  

RedRed

This will signify that a product is not recommended for prescribing in both primary and secondary care. All new products are classified as RED-RED pending assessment by PACEF.   

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