Data extracted : 24/11/2017
 Formulary Section 4: Central nervous system
04.01 Hypnotics and anxiolytics
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
Link   CSM Advice: Benzodiazepine withdrawal
04.01.01 Hypnotics

  • 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

Link   LPT Hypnotic Guidance
Link   NICE CG 26: Post-traumatic stress disorder (PTSD)
Link   NICE TA 77: Insomnia -newer hypnotic drugs
First Choice:
As with benzodiazepines avoid prolonged use (risk of tolerance and withdrawal symptoms).
Second Choice:
May be considered if patient experiences hangover effect with zopiclone.
Second Choice:
Restricted Drug  Temazepam 
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.
Restricted Drug  Melatonin 
Classified as simple amber for indications included in LMSG guidance.

Melatonin is classified as 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.

Circadin® (Melatonin) 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.
However this product may be used off label for other approved indications as specified above
Restricted Drug  Promethazine  
NICE recommends a sedating antihistamine is suitable for treating insomnia in patients who maybe prone to the development of tolerance and addiction
Restricted Drug  Sodium Oxybate 
For initiation by sleep clinic at UHL only
04.01.02 Anxiolytics

  • 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
Link   NICE CG 113: Generalised anxiety disorder and panic disorder in adults
First Choice:
Restricted Drug  Lorazepam 
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.

04.02 Drugs used in psychoses and related disorders

  • For new onset psychosis seek specialist psychiatric advice

  • If the therapeutic goal is calming then a benzodiazepine may be more appropriate. These should only be prescribed for short periods.

  • If there is an ongoing requirement for antipsychotics seek specialist advice.

  • ECG monitoring is required before initiation of many antipsychotic drugs. Check SPC before prescribing

  • Patients on atypical antipsychotics should be monitored in line with the Leicestershire Partnership Trust Guidance on the monitoring of metabolic parameters in patients prescribed regular antipsychotics and agreed shared care agreement for prescribing of atypical antipsychotics. 

  • The Royal College of Psychiatrists has issued advice on the use of antipsychotics above their licensed dose.  Leicestershire Partnership Trust (LPT) guidance available below.

  • There is a clear increased risk of stroke and a small increased risk of death when antipsychotics (typical or atypical) are used in elderly people with dementia. Local guidance on management of behavioural problems in dementia and an antipsychotic drug prescribing care plan in dementia have been produced. 

  • Levomepromazine is also used in the treatment of nausea and vomiting associated with cytotoxic therapy.

  • Zuclopenthixol acetate (Clopixol Acuphase) is available for use only by specialists in psychiatric settings.

  • Haloperidol may be used by specialists in palliative care or ITU.  It is also an option for use in rapid tranquilisation if a parenteral form is required and appropriate.
Link   Leicestershire Guidance: Physical Monitoring for Patients on Antipsychotics
Link   LPT Guidance: High Dose Antipsychotics
Link   MHRA advice: Atypical antipsychotics: monitoring
Link   NICE CG 178: Psychosis and schizophrenia in adults (Replaces NICE CG82)
First Choice:
Restricted Drug  Amisulpride 

For use on the advice of a specialist in psychiatry.

Restricted Drug  Clozapine 
For use on the advice of a specialist in psychiatry.
Treatment resistant schizophrenia. Classified RED i.e. not suitable for GP prescribing

Restricted Drug  Flupentixol 
For use on the advice of a specialist in psychiatry for schizophrenia
Restricted Drug  Lurasidone 
Schizophrenia in adults aged 18 years and over.
For those who do not respond to or do not tolerate aripiprazole, or those who are not suitable for clozapine.
Restricted Drug  Olanzapine 

For use on the advice of a specialist in psychiatry. Also licensed for treatment of mania.

Long-term safety and tolerability of olanzapine:
Following long-term (>24 weeks) treatment with olanzapine, the types of metabolic changes seen in young people aged 12−18 years are similar to those seen in adults. However, the magnitude of changes in parameters such as body weight and some blood lipid levels appears to be greater in young people

Restricted Drug  Promazine Hydrochloride 
Short term adjunctive management of psychomotor agitation
Option for the treatment of agitation in the elderly but see also guidance on treatment of behavioural disturbance in dementia below.
Restricted Drug  Quetiapine  
Immediate release tablets only. For use on the advice of a specialist in psychiatry in line with NICE Clinical Guideline for Bipolar Disorder only.
Restricted Drug  Sulpiride 
If for use in schizophrenia or psychoses–to be initiated after discussion with specialist
Restricted Drug  Zuclopenthixol 
For use on the advice of a specialist in psychiatry
Restricted Drug  Aripiprazole Oral 
For bipolar disorder restricted to use in line with NICE TA
In Schizophrenia as an option if quetiapine causes problems with prolactin, aripiprazole is the drug of choice in these circumstances.

Date of entry of decision to Formulary:July 2013

Restricted Drug  Aripiprazole I.M. 
Intramuscular preparation available for Rapid Tranquilisation only.
04.02.02 Antipsychotic depot injections
Restricted Drug  Aripiprazole long-acting injection  (Abilify Maintena®)
Specialist in Psychiatry Initiation only
Restricted Drug  Flupentixol Decanoate 
Specialist in Psychiatry Initiation only
Restricted Drug  Fluphenazine Decanoate 
Specialist in Psychiatry Initiation only
Restricted Drug  Haloperidol Decanoate 
Specialist in Psychiatry Initiation only
Restricted Drug  Risperidone  (Risperdal Consta®)
Specialist in Psychiatry Initiation only.
Restricted Drug  Zuclopenthixol Decanoate 
Specialist in Psychiatry Initiation only.
Restricted Drug  Olanzapine embonate (olanzapine pamoate)  (Zypadhera®)
For use by specialists in psychiatry only
04.02.03 Drugs used for mania and hypomania
Olanzapine is also licensed for treatment of mania
Link   MHRA Advice: Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions associated with the HLA-A* 3101 allele.
Link   NICE CG 185: Bipolar disorder (Replaces CG38)
Restricted Drug  Carbamazepine 
Specialist in Psychiatry Initiation only.
Restricted Drug  Lithium 
Specialist in Psychiatry Initiation only. BNF recommends to prescribe by brand. Priadel is the brand recommended for new patients due to cost.
Restricted Drug  Semisodium Valproate  (Depakote®)
Mania in bipolar disorder. Specialist in Psychiatry Initiation only.
04.03 Antidepressant drugs

  • Antidepressants are not recommended for the initial treatment of mild depression

  • Patients should be informed of delay in onset of action, potential side effects and the risk of withdrawal / discontinuation symptoms

  • If a patient fails to respond to the first antidepressant prescribed, check compliance and side effects before a gradual increase in dose in line with the schedule suggested by the Summary of Product Characteristics.

  • Consider switching to another antidepressant if there has been no response after a month. If there has been a partial response, a decision to switch can be postponed until 6 weeks.

  • Antidepressants should be continued for at least six months after remission of an episode of depression, because this greatly reduces the risk of relapse.

  • There is an increased risk of bleeding when SSRIs are given with NSAIDs or aspirin.  If no alternatives are appropriate NICE guidance recommends that gastroprotection is offered. 

  • Cumulative use of drugs with anticholinergic side effects have been shown to be associated with an increased risk for dementia. The long-term impact of prescribing these drugs should be considered when initiating them as the untoward effects may not be reversed by withdrawing them later down the line.
Link   NICE CG 113: Generalised anxiety disorder and panic disorder in adults
Link   NICE CG 26: Post-traumatic stress disorder (PTSD)
Link   NICE CG 28: Depression in children and young people
Link   NICE CG 31: Obsessive Compulsive Disorder
Link   NICE CG 9: Eating disorders
Link   NICE CG 90: Depression in adults (Update)
Link   NICE CG 91: Depression in adults with a chronic physical health problem
First Choice:
Higher cost than citalopram.
The cost of sertraline has increased significantly due to fluctuating supply problems. Consider citalopram as first line in new patients unless inappropriate e.g. patients with QT prolongation.
First Choice:
Cost effective choice in patients where QT interval prolongation is not an issue (see MHRA advice below for detail) Maximum daily dose 40 mg for adults; 20 mg for patients older than 65 years; and 20 mg for those with hepatic impairment.
Also licensed for panic disorder
Second Choice:
Second Choice:
For depression, in line with SCA
Restricted Drug  Lofepramine 
If a tricyclic is considered appropriate.
Restricted Drug  Paroxetine 
Specialist use for the treatment of OCD
Restricted Drug  Venlafaxine 
Third line only. Please note that venlafaxine twice daily tablets should be considered first as they have a lower cost acquisition than Sustained Release once daily preparations.
For doses >300mg traffic light status is Amber
Restricted Drug  Clomipramine 
For initiation by or on the advice of a specialist in psychiatry. For OCD only in line with NICE CG 31. Not recommended as an initial choice for non specialists.
Restricted Drug  Mianserin 
As an option a)If the patient is on specific concurrent medication likely to interact with usual choices. b)In resistant depression as augmentation therapy. See NICE guidance below. For initiation by or on the advice of a specialist in psychiatry.
Restricted Drug  Moclobemide 
Reversible monoamine-oxidase inhibitor (RIMA)
For initiation by or on the advice of a specialist in psychiatry.
Not recommended as an initial choice for non specialists.
Restricted Drug  Phenelzine 
For initiation by or on the advice of a specialist in psychiatry. Option in PTSD
Restricted Drug  Escitalopram 
’Green for treatment resistant depression and generalised anxiety disorder only

’Green All indications except treatment resistant depression and generalised anxiety disorder

The MHRA has advised that escitalopram is associated with dose-dependent QT interval prolongation and should not be used in those with: congenital long QT syndrome; known pre-existing QT interval prolongation; or in combination with other medicines that prolong the QT interval. ECG measurements should be considered for patients with cardiac disease, and electrolyte disturbances should be corrected before starting treatment.
For escitalopram, the maximum daily dose for patients older than 65 years is now reduced to 10 mg/day.
Restricted Drug  Vortioxetine 
Third line only

Date of entry of decision to formulary: February 2016
04.04 CNS stimulants and other drugs used for attention deficit hyperactivity disorder
Link   NICE CG 72: ADHD
Link   SCA: ADHD Adults
Link   SCA: ADHD in children and adolescents
First Choice:
Restricted Drug  Methylphenidate 
Specialist paediatric initiation only.
Prescribe methylphenidate modified release by brand; different brands have specific release characteristics which may be tailored to individual patient circumstances (Equasym XL, Medikinet XL, Concerta XL).
Methylphenidate immediate release preparations are interchangeable and can be prescribed generically.
Restricted Drug  Atomoxetine 
Specialist paediatric initiation only.
Restricted Drug  Dexamfetamine 
Specialist paediatric initiation only.
Restricted Drug  Lisdexamfetamine mesilate 
Lisdexamfetamine is a Schedule 2 controlled drug
For ADHD refractory to methyphenidate. Specialist initiation only.
May also be used as an alternative to a ’specials’ preparation in patients unable to swallow solid dosage forms. (Off-label use if not refractory to methylphenidate)
The capsule can be opened and the entire contents dissolved in a glass of water. See SPC for further detail

Restricted Drug  Guanfacine 
Specialist paediatric initiation only
Restricted Drug  Modafinil  (Provigil®)
For treatment of narcolepsy only. Restricted to initiation by Specialist at Sleep Clinic
04.05 Drugs used in the treatment of obesity

  • Obesity is a risk factor for cardiovascular disease, diabetes, gallstones and osteoarthritis. The simplest and most effective method to lose unwanted weight is to consume fewer calories than are required to maintain current body weight. If an increase in physical activity is also combined with this approach, weight loss will be accelerated.
  • Drugs to increase weight loss should only be prescribed for individuals with a BMI of 30 kg/m2 or above and in whom a 3-month program including supervised diet, exercise and behaviour modification has failed to produce a reasonable weight loss.
  • If other medical risk factors are present (e.g. coronary heart disease, diabetes hypertension or sleep apnoea) it may be appropriate to introduce drug treatment at a BMI of 28 kg/m2 or greater.
Link   Leicestershire Guidelines: Diabetes (pages14-15)
Link   NICE CG 43: Obesity
Prescribe in line with NICE guidance.
Treatment with orlistat should be discontinued after 12 weeks if less than 5% of the body weight has been lost since the start of therapy.
04.06 Drugs used in nausea and vertigo

  • Anti-emetics should only be prescribed when the cause of nausea or vomiting is known. If an anti-emetic is indicated, the drug should be chosen according to the aetiology.

  • Metoclopramide, prochlorperazine and haloperidol may cause extrapyramidal side effects, particularly in children and young adults. Domperidone is much less likely to cause these. Acute dystonias may be treated with procyclidine injection.

  • Sickness in pregnancy is best left untreated unless severe. Specialist advice should be sought before using an antiemetic in pregnancy.

  • Dexamethasone, Lorazepam and Levomepromazine are also used in nausea and vomiting associated with cytotoxic therapy.

  • Levomepromazine tablets are available as 25mg strength and also as a 6mg (unlicensed) strength to assist administration of smaller doses. Take care when prescribing that the correct strength is specified.

  • For further information on prescribing of anti-emetics in malignancy see ’Nausea and Vomiting’ section (page 18) of Leicestershire guidance.

  • Hyoscine patches are occasionally used by specialists in palliative care or neurology for treatment of hypersalivation.

  • For further information regarding the use of anti-emetics in palliative care please see the LOROS guidance on symptom management.
First Choice:
Metoclopramide Hydrochloride 
For symptoms associated with gastro-duodenal, hepatic and biliary disease because it acts directly on the gastro-intestinal tract.
Can cause dystonic reactions in young adults.
The MHRA have advised that the maximum dose in adults in 24 hours is 30mg. The usual dose is 10mg up to three times a day. Treatment should be limited to a maximum of 5 days.
First Choice:
Nausea associated with vertigo.
Avoid in the elderly during very hot or very cold weather (risk of hyper- or hypothermia)
Second Choice:
Acts at the chemoreceptor trigger zone; used for the relief of nausea and vomiting associated with cytotoxic therapy. It is less likely to cause central effects (e.g. sedation and extrapyramidal reactions) because it does not readily cross the blood-brain barrier. It is preferred for patients with Parkinson’s disease or those with a high risk of dystonias.
Also has a place in the treatment of non-ulcer dyspepsia.
The MHRA has advised that there is a small risk of serious ventricular arrhythmia and sudden cardiac death with domperidone. See link below
Restricted Drug  Cyclizine 
If nausea or vomiting is unresponsive.
Cyclizine has antihistaminic and anticholinergic actions, which may be additive to the other agents listed. Sedative at higher doses.
Restricted Drug  Haloperidol 
Nausea or vomiting induced by opioids in palliative care. There have been shortages recently of haloperidol and also of the alternatives recommended. Therefore check LMSG statement below for alternatives.

The statement does not apply to treatment of delirium on ITU at UHL. Relevant clinicians will receive appropriate guidance as required.
Restricted Drug  Cinnarizine + Dimenhydrinate   (Arlevert®)
For dizziness in Meniere’s Disease use only when other medical therapies have failed
Restricted Drug  Ondansetron 
Use for chemotherapy induced nausea based on emetegenicity of the regime. Given on day of chemotherapy only or for an additional two doses if indicated. For radiotherapy induced nausea given daily during treatment if radiation to susceptible area (e.g. lower abdomen). Long term administration for chemotherapy or continuation for delayed emesis not recommended.
Melts have significantly higher cost than tablets - ’Films’ preferred if unable to swallow tablets.
IV Monograph available through ’Injectable Medicines Guide’ link on front page of INsite.
The new maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) in adults is now 16 mg (infused over at least 15 minutes)- See MHRA advice via link below
Restricted Drug  Droperidol  
Specialist anaesthetics use at UHL as a 3rd line option after cyclizine and ondansetron
04.07 Analgesics
04.07.01 Non-opioid analgesics and compound analgesic preparations

  • Paracetamol is usually adequate for mild pain. Regular doses are more effective than if presrcibed ’when required’.

  • With paracetamol, a dose reduction is necessary in adults with certain risk factors and/or low body weight.

  • Non-steroidal anti-inflammatory drugs (NSAID) such as ibuprofen are an alternative first step in the analgesic ladder.
First Choice:
Soluble paracetamol tablets should only be used if essential as they have a higher cost than standard preparations. They should be used with caution in patients with hypertension due to the sodium content.
04.07.01 Compound analgesic preparations

  • Doses of codeine >30mg are associated with a significant increase in undesirable effects.

  • In patients with chronic pain, if a weak opioid is required in addition to paracetamol, prescribe separately initially so that the dose can be titrated to optimum effect.
First Choice:
Paracetamol and codeine  (Co-codamol® 8/500)
Caution: Abuse potential in prisons.
First Choice:
Paracetamol and codeine  (Co-codamol® 30/500)
Soluble tablets should only be used if essential as they have a higher acquisition cost than standard preparations.
Caution: Abuse potential in prisons.
04.07.02 Opioid analgesics

  • Opioids need to be used carefully. There have been a number of reports to the NPSA of deaths and severe harm due to the administration of high doses (30mg or greater) of diamorphine or morphine injections to opioid naive patients. Always check and confirm previous doses before prescribing and don’t increase doses by more than 50%.

  • A closely monitored trial is recommended before deciding whether a patient is prescribed opioids for long term use in chronic non palliative pain. Long and short term adverse effects need to be taken into consideration before initiating.  

  • 80% of patients taking opioids will experience at least one adverse effect which should be treated symptomatically. Tolerance to some side effects usually occurs within the first few days of initiating treatment eg nausea, vomiting, dizziness and somnolence but pruritis and constipation tend to persist. All opioids have the potential to cause physical dependence, tolerance and addiction.

  • Naloxone injection which can reverse opioids should be available in all clinical locations where opioid injections are used in case of overdose.

  • E-learning modules on pain management are available on the MHRA website and e-UHL for UHL staff
For advice on pain control in cancer or palliative pain of cancer origin or progressive, life limiting and near death conditions contact the Palliative Care Teams LRI ext. 7512 or 5414, LGH ext. 4680, GGH ext. 3540.
These numbers are converted into direct dial lines by prefixing with (0116) 258 xxxx
LOROS (0116) 231 8415.
The LOROS guidance provides information on symptom management at the end of life, including pain control
For advice on pain control in non palliative pain where the condition is not immediately life limiting use the following options.
Contact the Leicestershire Pain Service (0116) 258 5653 for advice.
Refer UHL inpatients via ICM to inpatient pain service.
Refer Primary care patients to Chronic Outpatient Pain Service
Link   British Pain Society Good Practice Guidance: Opioids for Persistent Pain
Link   Leicestershire Guidelines: Initial Dose and Titration of Opioids in Patients With Chronic Non Palliative Pain
Link   Leicestershire Guidelines: Morphine Equivalence Table in Chronic Non Palliative Pain
Link   LOROS: Guidelines for the Management of Common Symptoms in the Last Few Days of Life
Link   MHRA Advice: Codeine-containing pain relief in children: safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
Link   NICE CG140: Opioids in palliative care
Link   NPSA alert: Reducing dosing errors with opioid medicines.
Link   Parenteral IV opioid PRN doses for acute pain
Link   QIPP Detail Aid: Buprenorphine patches - a high price for convenience?
Link   UHL Guidelines: A Guide to Prescribing for Patients with Established Renal Failure
First Choice:
Codeine Phosphate 
15mg and 30mg tablets.
Caution: Abuse potential in prisons.
First Choice:
Dihydrocodeine Tartrate 
Useful for patients who don’t respond to codeine or who take medicines that prevent codeine from working.
Dihydrocodeine syrup 10mg/5ml is available but should only be used if essential as it has a higher acquisition cost than the tablets.
First Choice:
Schedule 2 Controlled Drug
Second Choice:
Buprenorphine patches 
For patients with stable palliative pain and also in patients with stable chronic non palliative pain who can’t tolerate oral morphine.
Restricted Drug  Diamorphine Hydrochloride (Injection) 
Alternative if necessary to give a high dose of opioid via a syringe driver as more soluble than morphine.
Schedule 2 Controlled Drug
Restricted Drug  Fentanyl (Patches) 
Expensive. Lowest strength patch equivalent to large equivalent dose of oral morphine.
Initiation restricted to patients with:
Stable palliative pain.
Established renal failure in accordance with UHL guidelines.
UHL patients with stable chronic non palliative pain on advice of UHL Pain Team.
Schedule 2 Controlled Drug
Restricted Drug  Oxycodone 
For patients with palliative pain and also in patients with chronic non palliative pain on advice of UHL Pain Team.
Schedule 2 Controlled Drug

Specify either immediate release or modified release on the prescription to avoid confusion between preparations.

NB Generic modified release preparations are labelled by the companies as Prolonged release. We are aware that this may cause some confusion and have raised with the MHRA
Restricted Drug  Oxycodone + naloxone  (Targinact®)
Initiation restricted to recommendation of a UHL pain consultant or palliative care consultant for patients who are significantly affected by opiod-induced constipation in whom laxatives have not worked or produced unacceptable side effects.
Schedule 2 Controlled Drug
Restricted Drug  Pethidine Hydrochloride 
For use in obstetrics only as it is associated with less respiratory depression in the neonate than morphine.
Schedule 2 Controlled Drug
Restricted Drug  Tramadol 
Schedule 3 Controlled drug (exempt from Safe Custody Regulations).
In chronic non palliative pain use only if weak opioids or NSAIDS have proved problematical or pain is uncontrolled. Avoid in elderly patients.
Use of tramadol should be limited to the lowest effective dose for the shortest possible time. Also used for post-operative patients orally or parenterally. Upon discharge, review dose/use and limit supply.
For prison use: Use with caution, treated with full CD regulations in this setting. Only prescribe as 24 hour preparation.
Restricted Drug  Tapentadol SR 
Supported for use by or under the guidance of pain clinic clinicians only for chronic pain in patients requiring opiates but not responding as expected to morphine. Immediate release preparation in acute pain not supported

Also supported for use in cancer pain for the same place in therapy as above.
04.07.03 Neuropathic pain
Algorithms for treatment of neuropathic pain, trigeminal neuralgia and post-herpetic pain are included in the guidance at the link below. Drugs available for use within these pathways include tricyclics, gabapentin (generic), pregabalin (prescribe as Lyrica for this indication), duloxetine, lidocaine plasters and capsaicin cream.  
Pregabalin can be prescribed twice daily compared to three times daily for gabapentin however this should make little difference to the majority of patients.  Prescribing pregabalin three times a day is very expensive.
Professionals prescribing pregabalin and gabapentin should be aware that these drugs can lead to dependence and may be misused or diverted.
Link   Leicestershire Evaluation: Lidocaine plaster in Focal Neuropathy
Link   Leicestershire Guidelines: Neuropathic pain
Link   NICE CG 173: Neuropathic pain - pharmacological management (Replaces NICE CG 96)
04.07.04 Antimigraine drugs Treatment of the acute migraine attack

  • New NICE guidance now recommends that combination treatment for acute migraine using a triptan plus an NSAID, or a triptan plus paracetamol are the most clinically and cost effective options for treatment of acute migraine offering a more rapid and prolonged benefit.

  • Oral sumatriptan has more evidence from randomised controlled trials to support its use than any other triptan although efficacy varies amongst individuals. Therefore prescribe triptans generically and start with the one with the lowest cost. If this is consistently ineffective, try one or more alternative triptans eg naratriptan, eletriptan, rizatriptan, frovatriptan and almotriptan. QIPP detail aid: TRIPTANS – choice of agent.

  • For women and girls with predictable menstrual-related migraine that does not respond adequately to standard acute treatment, consider treatment with zolmitriptan or frovatriptan on the days migraine is expected.

  • Giving an anti-emetic a few minutes before the analgesic can improve gastric motility and enhance absorption (even in the absence of nausea and vomiting) eg metoclopramide or domperidone. Prochlorperazine or domperidone suppositories are useful if vomiting has commenced.

  • If vomiting restricts oral triptan therapy despite an anti-emetic, zolmitriptan nasal spray is the preferred option as significantly more (30%) is absorbed through the nasal mucosa than sumatriptan nasal spray which is mostly absorbed in the GI tract. Oro- dispersible tablets dissolve on the tongue and are convenient to take but are absorbed in the GI tract and not the buccal mucosa.

  • A holistic approach should be adopted when treating migraine; lifestyle and behavioural triggers should be identified that increase the frequency of attacks resulting in over use of medication. This increases the risk of adverse effects and can also cause medication overuse headache. Information on prevention of over use headache can be found here.

  • Do not offer ergots or opioids for the acute treatment of migraine.
Link   NICE CG 150: Headaches in over 12s: diagnosis and management
Link   QIPP detail aid: TRIPTANS – choice of agent
First Choice:
Sumatriptan (oral) 
Prescribe generically. In trials, oral sumatriptan 50mg and 100mg strengths showed similar onset, analgesic efficacy and tolerability but the response to the 50mg strength was less consistent.
Second Choice:
Zolmitriptan (oral) 
Prescribe generically.
Restricted Drug  Rizatriptan Wafers 
Dissolves on the tongue without water, which is convenient to take and rapidly absorbed.
Due to high cost, restricted preparations should be reserved for occasions where oral administration is problematic.
Restricted Drug  Sumatriptan (nasal spray and injection) 
Due to high cost, restricted preparations should be reserved for occasions where oral administration is problematic.
Nasal spray is less costly than injection.
Restricted Drug  Zolmitriptan (nasal spray) 
Due to high cost, restricted preparations should be reserved for occasions where oral administration is problematic. Prophylaxis of migraine

  • Prophylaxis is recommended if attacks are frequent (one or more per fortnight).

  • Review need for continuing prophylaxis at 6 month intervals.

  • Current treatment with non formulary choices for prophylaxis may be continued in patients whose migraine is well controlled.
Link   Botulinum toxin Order Form
Link   NICE TA 260: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine.
Link   UHL Guidelines: Botulinum Toxin
First Choice:
Propranolol immediate release 
Avoid abrupt withdrawal.
Second Choice:
More expensive than propranolol. Teratogenic-avoid in women of child bearing age.
Useful for mixed presentation headache.
Nortripyline is a less sedative alternative used by local specialists although there is no formal evidence of efficacy; it is more costly than amitriptyline.
Use with caution in the prison environment.
Restricted Drug  Botulinum Toxin Type A  
Botulinum Toxin Type A in line with the NICE TA260
A request form should be completed, see link below.

Date of entry of decision to Formulary: September 2012
Flunarizine  (Sibelium®)
Unlicensed medication for prophylaxis of migraine in adults. For initiation by secondary care specialist only.
To be used once other medications have been unsuccessful
04.08 Antiepileptics
04.08.01 Control of epilepsy

  • Epilepsy can be described as idiopathic (or primary) generalised epilepsy (tonic-clonic convulsions, typical absences, myoclonic and atonic seizures), or focal (partial) epilepsy with or without secondary generalisation.

  • Anti-epileptic drugs (AED) therapy should be initiated on the recommendation of a specialist once the diagnosis has been confirmed.

  • Whenever possible treatment should involve a single AED. A second drug for a single seizure type should be considered only when the first choice drug is ineffective despite adequate plasma concentrations. The first drug should then be withdrawn slowly.

  • Patients taking phenytoin, carbamazepine, phenobarbital or primidone should be stabilised on one particular brand or generic and this should be quoted on all prescriptions and correspondence. See MHRA guidance on substitution of brands of all antiepileptic drugs.

  • Therapeutic monitoring is not routinely recommended but may be useful for monitoring in special situations or in selected patients. Plasma concentration measurements for sodium valproate do not correlate well with therapeutic effect and thus may not be useful.

  • Long term use of carbamazepine, phenytoin, primidone and sodium valproate is associated with decreased bone mineral density. Monitoring is necessary see Leicestershire Guidance - Antiepileptics and Bone Mineral Density

  • Care should be taken when prescribing AEDs for women and girls of reproductive age due to a possible increased risk of birth defects. Avoid sodium valproate in this population. Referral to a specialist is necessary if considering pregnancy. Levetiracetam and lamotrigine are considered to have a lower teratogenic risk. Folic acid 5 mg per day should be prescribed before any possibility of pregnancy.

  • Hormonal contraception may affect or be affected by AEDs.
Link   Faculty of Sexual and Reproductive Health: Antiepileptic Drugs and Contraception
Link   Leicestershire Guidance: Antiepileptics and Bone Mineral Density
Link   MHRA Advice: Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions associated with the HLA-A* 3101 allele.
Link   MHRA Advice: Retigabine: indication restricted to last-line use, and new monitoring requirements after reports of pigment changes in ocular tissue, skin, lips, or nails.
Link   MHRA Advice: St John’s wort: interactions with all antiepileptics
Link   NICE CG 137: Epilepsy
Link   NICE TA 232: Retigabine for the adjunctive treatment of partial onset seizures in epilepsy
Link   Simple Amber: Lacosamide, Pregabalin and Zonisamide for Refractory Epilepsy.
Link   Simple Amber: Rufinamide for Lennox-Gastaut Syndrome
Link   Toxicology and Therapeutic Dose Monitoring
First line for focal (partial) epilepsy and alternative to sodium valproate for idiopathic generalised epilepsy; may exacerbate myoclonic seizures.
Lamotrigine is generally well tolerated but use has been associated with serious blood disorders and skin reactions. Initiate slowly.
Sodium Valproate 
First line for all types of idiopathic generalised epilepsy.
Avoid in women of reproductive age as it is the most teratogenic anticonvulsant.

Alternative in focal partial epilepsy and idiopathic generalised epilepsy. Levetiracetam has a different mode of action to lamotrigine and carbamazepine.

Intravenous preparation is classified as Red on the Leicestershire traffic lights.
Alternative for focal (partial) epilepsy and useful if rapid titration is required but is generally less well tolerated.
Alternative to sodium valproate for typical absence seizures.
Restricted Drug  Phenytoin 
3rd line drug due to long term side effects.
Also indicated in the management of seizure activity following brain injury.
Restricted Drug  Clobazam 
Restricted Drug  Clonazepam 
Restricted Drug  Gabapentin 
Restricted Drug  Oxcarbazepine 
Restricted Drug  Phenobarbital 
Restricted Drug  Piracetam 
Restricted Drug  Primidone 
Restricted Drug  Tiagabine 
Restricted Drug  Topiramate 
’Green when prescribed in line with neuropathic pain guidelines.

’Amber simple amber when used for refractory epilepsy or generalised anxiety disorder
Restricted Drug  Lacosamide 
Restricted Drug  Rufinamide 
Restricted Drug  Zonisamide 
Restricted Drug  Brivaracetam 
Specialist initiation only. Third line alternative
Restricted Drug  Eslicarbazepine 
Restricted Drug  Perampanel 
Restricted Drug  Retigabine 
Retigabine is due to be withdrawn in 2017. Existing patients to have therapy reviewed by a specialist and no new patients to start therapy with retigabine.

The MHRA have restricted retigabine to last-line use, after reports of pigment changes in ocular tissue, skin, lips or nails.
04.08.02 Drugs used in status epilepticus
Link   UHL Guidelines: Status epilepticus
First Choice:
Phenytoin IV 
First Choice:
Lorazepam IV 
Second Choice:
Diazepam (rectal solution) 
Alternative to lorazepam if there is no IV access.
Injection by intramuscular route and suppositories are unsuitable due to slow absorption and should not be used.
Second Choice:
IM or buccal midazolam can be given as an alternative to lorazepam if there is no IV access. This is an unlicensed indication.
A licensed product, Buccolam, is now available for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years) For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
04.09 Drugs used in parkinsonism and related disorders
04.09.01 Dopaminergic drugs used in Parkinsons disease

  • All for specialist recommendation or initiation based on individual circumstances, local guidance and shared care agreements (SCA) listed below.

  • Excessive daytime sleepiness and sudden onset of sleep can occur with levodopa substitutes and dopamine receptor agonists.


Link   Leicestershire Guidelines: Algorithm for the Pharmacological Treatment of Parkinson’s Disease
Link   MHRA Advice: Dopamine agonists: pathological gambling, increased libido, and hypersexuality.
Link   NICE CG 35: Parkinsons Disease
Link   SCA: Pramipexole and Rotigotine for restless legs
Link   Simple Amber: Antiparkinson drugs
First Choice:
Cheaper than co-careldopa and should be tried first as there is no evidence of benefit of one over the other.
First Choice:
Simple amber for treatment of Parkinson’s disease and restless leg syndrome.
Ropinirole XL is available as a generic preparation. UHL will prescribe generically, primary care may specify a brand according to price.
First Choice:
Treatment of Parkinson’s disease and restless leg syndrome.
Modified release (MR)is much more expensive than intermediate release (IR). It is restricted to initiation only on consultant recommendation after a trial with the immediate release pramipexole has not been tolerated. Treatment should then be reviewed to establish additional benefits and if none are apparent then the patient should revert to the IR. Patients established on therapy who have demonstrated benefit on MR should not be switched to IR.
First Choice:
First Choice:
Second Choice:
More expensive than co-beneldopa. Reserve for patients who are currently stabilised on it and for patients who don’t respond or tolerate co-beneldopa.
Second Choice:
For treatment of Parkinson’s disease and restless leg syndrome.

Available as a first line choice for prescribing by specialists experienced in the treatment of Parkinson’s disease (Neurologists and Geriatricians)
Second Choice:
Available as individual component and as combined product.
Stalevo and Stanek both contain same quantities of carbidopa/entacapone/levodopa.
UHL currently stocks Stanek
Safinamide  (Xadago®)
For treatment of Parkinson’s disease
Specialist neurology use only
For use in Parkinson’s disease in line with shared care agreement
04.09.02 Antimuscarinic drugs used in parkinsonism

  • Anticholinergic agents may sometimes be of use in reducing mild tremor but have little effect on rigidity or bradykinesia. They are no longer routinely recommended in treatment of Parkinson’s disease but may be used in selected patients under specialist advice. 

  • Anticholinergic agents can reduce the severity of drug induced parkinsonian symptoms. Akathisia does not usually respond well and tardive dyskinesias may be made worse

  • Prophylactic use with antipsychotics is not recommended. Treatment may be started if symptoms occur but should be reviewed every 3 months for continuing need.

  • Use with caution in elderly patients because they tend to cause mental confusion.

  • Cumulative anticholinergic medication use  has been shown to be associated with an increased risk for dementia. The long-term impact of prescribing these drugs should be considered when initiating them as the untoward effects may not be reversed by withdrawing them later down the line.


First Choice:
Procyclidine Hydrochloride 
Drug induced parkinsonian symptoms.
Injection acts quickly and is effective in relieving acute dystonic reactions caused by dopamine- blocking agents including antipsychotics and metoclopramide.
Second Choice:
Trihexyphenidyl (Benzhexol) 
04.09.03 Drugs used in essential tremor, chorea, tics, and related disorders
Restricted Drug  Botulinum Toxin   (Xeomin®)
In line with licensed indications

Restricted Drug  Botulinum Toxin Type A / B  (Botox® / Neurobloc® / Xeomin® )
Supported by Therapeutic Advisory Service and funding supported by Commissioners for
Spasticity - post stroke, Multiple Sclerosis, traumatic or medical brain injury, hereditary spastic paraparesis.
Dystonia - includes cervical dystonia, hemifacial spasm and blepharospasm, tic in ophthalmology.
Bladder - neuropathic bladder, bladder instability, refractory detrusor overactivity, urge incontinence.
Anismus.Anal fissure unresponsive to GTN/ diltiazem ointment
NOT supported for chronic constipation in children

Commissioning policy in development. Dysport® should be reserved for use in a) ophthalmology for use in extra ocular muscles b)patients already on therapy who had previously not responded to Botox®
Riluzole  (Rilutek®)
04.10 Drugs used in substance dependence
Link   Further Information: Smoking Cessation
04.10 Alcohol dependence
Acamprosate or oral naltrexone may be initiated by specialists for maintenance treatment to prevent relapse after successful withdrawal from alcohol.  Both are classed as simple amber on the Leicestershire Traffic Light system so GPs can continue prescribing in primary care.  There is no requirement for a shared care agreement to be in place.
Alcohol dependance
04.10 Cigarette smoking

Smoking Cessation- Prescribing Points

  • Smoking remains the biggest preventable cause of ill-health and premature death and the biggest driver of health inequalities particularly cancer, coronary heart disease and respiratory disease.

  • All patients, wherever they are, who wish to quit smoking can be referred to the Leicestershire NHS STOP! Smoking Service.  

  • Behavioural therapy should always be provided alongside pharmacotherapy either as direct provision or by the STOP! Smoking Service, as it significantly increases the chance of quitting successfully.

  • Most smokers need to make multiple attempts to quite before achieving long-term success.Treatment should be available for more than one episode providing patients are adequately motivated to attempt to stop smoking again.

  • Appropriate governance mechanisms should be in place to provide comprehensive advice on treatment, monitor use, agree quit dates and a plan of ongoing support at the end of treatment.

  • Smoking is not allowed on secondary care premises.

  • Smoking cessation medications should be chosen according to patient specific requirements. Consider patient preference, motivation, cigarettes smoked per day, the time to the first cigarette of the day, desired speed of nicotine delivery, ability to adjust and titrate nicotine dose, tolerance for side effects, interactions and ease of use.  In more dependent smokers a combination of short and long acting NRT should be considered to relieve craving.

  • NRT can be prescribed for in-patients over the age of 12 years for the short term management of craving and withdrawal symptoms. 

  • All in-patients who smoke should be encouraged to agree to referral to STOP! Smoking Service. In patients unwilling to be referred for smoking cessation NRT can be offered for temporary abstinence or to allow a reduction in smoking in line with NICE PH45 Tobacco: harm reduction approaches to smoking.

  • Smoking cessation can affect levels of medication and dose adjustment may be necessary e.g. clozapine.  Further information and advice can be obtained from the Medicines Information Service on 0116 258 6491.

  • The risks and benefits of NRT should be discussed with pregnant women who smoke, particularly those who do not wish to accept the offer of help from the NHS Stop Smoking Service. If a pregnant woman is unable to give up without pharmacological therapy the risks of NRT are lower than those of smoking tobacco  Pregnant women using nicotine patches should be advised to remove them before going to bed (use for 16 hours per day).
Link   NHS STOP Smoking Services. Service Monitoring & Guidance 2011/12
Link   NICE PHG1: Brief interventions and referral for smoking cessation.
Link   NICE PHG10: Smoking Cessation Services
Link   NICE TA123: Smoking cessation - varenicline
Nicotine Replacement Therapy 
≥ 10 cigarettes per day – NiQuitin Patch 21mg/24 hours applied daily
< 10 cigarettes per day – NiQuitin Patch 14mg/24 hours applied daily
In pregnant women recommend removing for 8 hours over night

  • NiQuitin Mini Lozenge 4mg
    One lozenge dissolved in the mouth whenever there is an urge to smoke (maximum 15 lozenges per 24 hours)
  • NiQuitin Strips 2.5mg Oral Film
    One strip to be dissolved in the mouth every 1-2 hours when there is an urge to smoke (maximum 15 strips per 24 hours)
  • Nicorette Inhalator 15mg
    Use whenever there is an urge to smoke (maximum 6 cartridges per day equivalent to approximately 48 x 5 minute sessions)
    Caution may be restricted in the prison environment.
  • Nicorette Quickmist 1mg/spray Mouthspray
    Use 1-2 sprays whenever there is an urge to smoke (maximum 4 sprays per hour and 64 sprays per 24 hours)

  • Full range available through the STOP! Clinics and primary care prescribers. Also available from community pharmacists under an enhanced service agreement .
    Bupropion Hydrochloride 
    Only available in primary care and STOP clinics
    The mode of action of bupropion in smoking cessation is unclear but may involve an effect on noradrenaline and dopamine neurotransmission. It should not be used in patients with a history of seizures, acute alcohol or benzodiazepine withdrawal, hepatic cirrhosis, CNS tumour, eating disorders or bipolar disorder.
    Only available in primary care and STOP clinics.
    Varenicline is a selective nicotine receptor partial antagonist and is currently extensively monitored by the MHRA for suicidal behaviour. If suicidal thoughts, depressed mood or agitiation develop, medical advice should be sought promptly and treatment discontinued. Patients with a history of psychiatric illness should not be prescribed varenicline.
    04.10 Opioid dependence
    Naltrexone may be initiated by specialists for maintenance treatment to help prevent relapse to opioid dependence.  
    This is classed as simple amber on the Leicestershire traffic light system so GPs may continue to prescribe without the need for a shared care agreement.
    04.10.01 Alcohol dependence
    Restricted Drug  Nalmefene 
    For use in line with NICE TA 325

    Date decision added to Formulary: February 2015
    04.10.02 Nicotine dependence
    04.10.03 Opioid dependence
    04.10.03 Opioid substitution therapy
    04.10.03 Adjunctive therapy and symptomatic treatment
    04.10.03 Opioid-receptor antagonists
    04.11 Drugs for dementia

    Donepezil is the first line choice.  The decision to use other cholinesterase inhibitors is based on consideration of individual patient factors.  Donepezil, rivastigmine and galantamine are recommended as options for managing mild to moderate disease in line with NICE TA 217.  Memantine is indicated for moderate disease if intolerance to or medical contraindication to AChE or severe Alzheimer’s.

    Link   NICE CG 42: Dementia
    Link   NICE TA 217: Donepezil, galantamine, rivastigmine and memantine for Alzheimer’s disease
    Link   SCA: Donepezil,Rivastigmine and Memantine
    First Choice:
    Restricted Drug  Memantine 
    See SCA for further detail
    Restricted Drug  Galantamine 
    Currently supplied by LPT