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 Formulary Chapter 4: Central nervous system - Full Chapter
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04.01  Expand sub section  Hypnotics and anxiolytics
 note  The Committee on Safety of Medicines (CSM) provides the following advice on benzodiazepine prescribing:
  • Benzodiazepines are indicated for the short-term relief (2-4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.
  • The use of benzodiazepines to treat short-term ‘mild’ anxiety is inappropriate and unsuitable.
  • Benzodiazepines should be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme distress.
    Abrupt withdrawal from benzodiazepines may produce confusion, toxic psychosis, convulsions, or a condition resembling delirium tremens. Therefore if a patient has been prescribed benzodiazepines long term withdrawal should be gradual
04.01.01  Expand sub section  Hypnotics
 note 
  • Consider non pharmacological treatments first e.g. sleep hygiene (Principles of sleep hygiene below, Leicestershire Partnership patient leaflet available here)
  • Prescribe a hypnotic only if severe insomnia is interfering with normal daily life
  • Limit to short period of time and review BNF advice.
  • If treatment with one of the recommended hypnotic medicines does not work, the doctor should not prescribe one of the others available.

Principles of sleep hygiene

  • Avoid excessive use of caffeine, alcohol or nicotine. A hot milky drink at bedtime may help promote sleep.
  • Do not stay in bed if not asleep.
  • Avoid daytime naps or periods of inactivity.
  • A warm bath or exercise a few hours before bedtime may promote sleep.
  • Avoid strenuous physical or mental activity near to bedtime.
  • Make sure the bed and bedroom are comfortable; avoid extremes of noise and temperature.
  • Rise at the same time every morning, regardless of sleep duration.

In patient use: recommendations

  • All PRN hypnotic prescriptions should be endorsed with a maximum frequency of 5 nights out of 7
  • PRN hypnotics should not be offered before 11pm
  • All regular hypnotic prescriptions should be assigned a review date of 2 weeks to ensure usage does not become long-term
  • All prescriptions for hypnotics on discharge should be queried unless the patient was a regular user of hypnotics prior to admission

Zopiclone
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First Choice
Green
As with benzodiazepines avoid prolonged use (risk of tolerance and withdrawal symptoms). 
Zolpidem
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Second Choice
Green

May be considered if patient experiences hangover effect with zopiclone. Zolpidem is contraindicated in people with psychosis

 
   
Temazepam
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Restricted Drug Restricted
Green
For patients who cannot tolerate other choices or who have previously responded to treatment.
The exemptions applied to Temazepam as a schedule 3 controlled drug have been removed. Temazepam should now be treated as a full CD. This includes ordering, storage, destruction and register requirements. In addtion there is a need for prescriptions to be written in words and figures and, in the hospital setting, the TTO letter should be printed and countersigned by the prescriber.  
   
Melatonin
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Restricted Drug Restricted

Melatonin 1mg/ml solution
There is now a licensed manufactured 1mg/1ml melatonin oral solution on the market. Please note this is contraindicated in children as it contains excipients at levels which can cause harm in children. For children please consider:
• First line crushing Circadin M/R tablets
• If a liquid is essential please prescribe a brand which is propylene glycol free and alcohol free such as Rosemont. This will need to be specified on the prescription.


For indications included in LMSG guidance. Simple amber classification only applies to doses up to 10mg daily.

Amber Simple for indications included in LMSG guidance. Simple amber classification only applies to doses up to 10mg daily.

Red  for circadian asynchrony in patients on HDU / ITU at UHL. It is also classified as RED for use for Huntington's Disease and learning disability.


 
Link  Leicestershire Guidance: Melatonin Guidelines for Children
Link  Simple Amber List
   
Melatonin M/R Tablets (Slenyto®, Circadin®)
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Formulary
Amber Simple

Please Prescribe By Brand Name

Circadin® - Approved for indications included in LMSG guidance. Simple amber classification only applies to doses up to 10mg daily. Circadin® is not supported for its licensed indication of primary insomnia in patients over 55 due to lack of evidence for effectiveness. This includes circadian asynchrony in elderly institutionalised patients.

Slenyto® - Approved for 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. New patients only

 
Link  Leicestershire Guidance: Melatonin Guidelines for Children
   
Promethazine
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Restricted Drug Restricted
Green
NICE recommends a sedating antihistamine is suitable for treating insomnia in patients who maybe prone to the development of tolerance and addiction 
   
Sodium Oxybate
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Restricted Drug Restricted
Amber Simple
High Cost Medicine
For initiation by sleep clinic at UHL only  
   
04.01.01  Expand sub section  Pitolisant
Pitolisant (Wakix®)
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Restricted Drug Restricted
Amber Simple

For treatment of narcolepsy.

Restricted to initiation by Specialist at Sleep Clinic.

 
   
04.01.02  Expand sub section  Anxiolytics
 note 
  • Limit to short period of time and review CSM Advice
  • Diazepam and its active metabolite have a long half life. There is a potential for accumulation especially in the very elderly.
  • Diazepam should only be given by the intramuscular route when oral and intravenous routes are not possible
  • Propranolol can often relieve the somatic symptoms of anxiety without the risks associated with benzodiazepine dependence
  • General Anxiety Disorder and Panic Disorder treatment options include antidepressant therapy
Diazepam
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First Choice
Green
 
Lorazepam
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Restricted Drug Restricted
Green
Lorazepam is shorter-acting than diazepam and seems more likely to produce dependence. For this reason it should only be prescribed as an anxiolytic for existing users or where treatment will be for a very short time (e.g. for its amnesic effect when a course of cytotoxic chemotherapy is administered). Lorazepam may occasionally be useful in calming an acutely agitated patient if used with an antipsychotic agent such as haloperidol.

 

Link  LPT Guidance: Rapid Tranquilisation Policy
Link  UHL Guidelines: Rapid Tranquilisation of Disturbed Adult Patients
   
 ....
 Non Formulary Items
Melatonin

View adult BNF View SPC online Track Changes
Non Formulary
Black

Indication: - Primary insomnia in adults. Circadian asynchrony in elderly institutionalised patients. This status is currently under review - May 2018

 
Melatonin (Colonis)  (1mg/ml oral solution)

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Non Formulary
Black

Short-term treatment of jet-lag in adults

 
  
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
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
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

Black

Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

Red

Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

Amber SCA

Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

Amber Simple

Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.  

Green Conditional

Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.   

Green

Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

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