MMG003 GUIDELINES FOR THE USE OF HYPNOTICS FOR THE TREATMENT OF INSOMNIA Page 1 of 11
Table of Contents Why we need this Guideline... 3 What the Policy is trying to do... 3 Which stakeholders have been involved in the creation of this Guideline... 3 Any required definitions/explanations... 3 Key duties... 3 Medicines Management Committee... 3 Medical Director... 3 Clinical Directors... 3 Heads of Hospitals and Locality Managers... 3 Doctors... 3 Nursing staff:... 3 MANAGEMENT OF PATIENTS REQUIRING A HYPNOTIC... 3 Types of hypnotics and formulary status... 4 Other hypnotics... 4 Management of patients on admission... 5 Actions before prescribing a hypnotic... 5 Responsibilities of prescribers... 5 Guidance For Nurses for the Administration of PRN Hypnotics... 6 Reviewing Hypnotic Use... 6 On Discharge... 6 Hypnotic use in older people... 7 NICE Guidance... 7 Summary... 7 Training requirements associated with this Guideline... 8 Mandatory Training... 8 Specific Training not covered by Mandatory Training... 8 How this Guideline will be monitored for compliance and effectiveness... 8 Equality considerations... 8 Document control details... 10 Appendix 1... 11 Page 2 of 11
Why we need this Guideline This guideline covers the use of benzodiazepines used as hypnotics and the 'Z' drugs e.g. zopiclone, zolpidem, zaleplon. It has been produced to help promote best practice on the use of benzodiazepines and z-drugs. What the Guideline is trying to do To provide guidance on the appropriate and safe use of hypnotics in controlling insomnia. Which stakeholders have been involved in the creation of this Guideline Medicines Management Committee meeting Any required definitions/explanations MHRA Medicines and Healthcare Products Regulatory Authority NHFT - Northamptonshire Healthcare NHS Foundation Trust NICE National Institute of Health Care and Excellence PRN (Pro re nata). Medication given on a when required basis SmPC Summary of Product Characteristics Key duties Medicines Management Committee Will approve and review these guidelines Medical Director Is responsible for the dissemination of this guideline to their Clinical Director's and Clinical Tutor's Clinical Directors Are responsible for the dissemination and implementation of the guideline in their service areas Heads of Hospitals and Locality Managers Are responsible for the dissemination and implementation of the guideline in their service areas Doctors Are responsible for reviewing the patient and ensuring all benzodiazepines and Z drugs are prescribed appropriately and reviewed in line with this guideline (see also section 6.4 below) Nursing staff: Are responsible for ensuring that prescribed benzodiazepines and Z drugs are administered in accordance with this guideline. (See also section 6.5 below). MANAGEMENT OF PATIENTS REQUIRING A HYPNOTIC Before a hypnotic is prescribed, the cause of the insomnia should be established and the underlying factors should be treated if possible. Short-acting hypnotics are preferable in patients with sleep onset insomnia, when sedation the following day is undesirable, or when prescribing for elderly patients. Long-acting hypnotics are indicated in patients with poor sleep maintenance (e.g. early Page 3 of 11
morning waking) that causes daytime effects, when an anxiolytic effect is needed during the day, or when sedation the following day is acceptable. Hypnotics should only be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme distress 1 Patients should be made aware at the beginning of treatment that tolerance develops after 3-14 days of continuous use with the effectiveness wearing off in the long term. 2 Long term use may also cause rebound insomnia and dependence. Hypnotics should be prescribed at the lowest effective dose and should not be given for more than three weeks, (preferably only one week) for short-term insomnia. Intermittent use is desirable with omission of some doses. Where prolonged administration is unavoidable hypnotics should be discontinued as soon as possible and the patient warned that sleep may be disturbed for a few days due to rebound effects before normal sleep pattern is re-established. Benzodiazepines and Z drugs are not recommended in the elderly as they are at greater risk of becoming ataxic and confused, leading to falls and injury. Types of hypnotics and formulary status Benzodiazepines Temazepam is a shorter acting benzodiazepine and available as tablets or elixir on the Northamptonshire Healthcare NHS Foundation Trust formulary. Nitrazepam, a longer acting benzodiazepine associated with residual effects the next day, is available for continuation of treatment only. The 'Z' drugs (zopiclone, zolpidem, zaleplon) At present, amongst the 'Z' drugs, only zopiclone is available on the Northamptonshire Healthcare NHS Foundation Trust formulary. Contrary to popular belief, the 'Z' drugs do cause hangover effects and tolerance can develop. Withdrawal after long-term use may cause rebound insomnia.. There is good evidence for the efficacy of hypnotic drugs in shortterm insomnia; however, their use is associated with adverse effects, such as daytime sedation, poor motor coordination, cognitive impairment, and related concerns about driving accidents and injuries from falls. Dependence has also been reported. The SmPC for zopiclone recommends 2-5 days use for transient insomnia and 2-3 weeks for short term insomnia. The maximum licensed dose of zopiclone is 7.5mg per day 5. Zopiclone is not licensed for long term use maximum licensed duration is 4 weeks, including tapering off. Other hypnotics Chloral hydrate is not on the formulary and is a locally restricted item. It is lethal in overdose, which may be unintentional, and therefore not recommended. Sedative antihistamines e.g. promethazine are sometimes used on a short term basis. Use may lead to hangover drowsiness the following day. The sedative effect may also diminish. Page 4 of 11
Management of patients on admission Patients who have not been taking a hypnotic should not routinely be prescribed one on admission. This should be prescribed only if considered essential. Regular users should not have their treatment stopped suddenly however consideration should be given to the need for ongoing therapy and reducing the dose. Actions before prescribing a hypnotic Insomnia is a distressing symptom which, if untreated can lead to sleep deficit problems such as memory problems, lack of concentration and can affect normal function and quality of life. Short term use of hypnotics is useful and can help restore sleep and normal functioning. However, tolerance and dependence is likely if patients continue treatment with hypnotics for longer than a few weeks. Non-pharmacological measures should be tried in the first instance and the patient should be advised about non-pharmacological therapies available (See Appendix 1): Advice on good sleep hygiene should be given and encouraged. Sleep hygiene aims to make people more aware of behavioural and environmental factors that may be detrimental or beneficial to sleep. Relaxation techniques Avoidance of day time naps Avoidance of caffeine drinks, nicotine, alcohol, heavy exercise and heavy meals in the evenings Reassurance should be given about sleep, i.e. in elderly people the need for sleep decreases with age. If then deemed necessary, hypnotics should be prescribed in line with their approved licensed indications and durations as per BNF recommendations i.e. not on a regular basis (PRN use) and should be reserved for short term use only. Before prescribing a hypnotic, patients should be informed that the effect wears off, that it can lead to dependence and that it will only be given for a short period. Antipsychotics should not be routinely used solely as hypnotics as this is outside their approved licensed indications. Reasons for prescribing a hypnotic should be documented in the clinical notes. Although hypnotics provide relief for insomnia, they do not treat the underlying cause. Should a hypnotic be required out of hours, the duty doctor should only prescribe a STAT dose in the 'once only medication' section of the prescription, with a view to the patient being reviewed by their own team the following day. Responsibilities of prescribers Ensure that all benzodiazepines and z-drugs are prescribed appropriately and reviewed in line with this guideline. All benzodiazepines and hypnotics should be reviewed on a weekly basis with clear documentation in the medical notes. Page 5 of 11
Patients who do not respond to one hypnotic, should not be prescribed any of the others unless an adverse effect has occurred that is directly related to a specific hypnotic. All hypnotics should be used within their licensed therapeutic indications and doses At discharge if benzodiazepines or hypnotics are continued, a clear management plan should be in place for GPs. Use with caution in those with liver impairment and those with alcohol dependence or illicit drug use. Guidance For Nurses for the Administration of PRN Hypnotics Ensure that prescribed benzodiazepines and z-drugs are administered in accordance with this guideline. Patients are to be encouraged to use relaxation techniques and to avoid stimulants e.g. discourage patients from having caffeine drinks or cigarettes late in the evening before administration of hypnotics. A sleep chart should be considered and completed for all patients complaining of sleep difficulties and this should be discussed with the ward doctor and at ward rounds. Do not routinely offer night sedation to all patients. They should only be administered on a on request basis once the nurse is satisfied that appropriate attempts have been made to go to sleep. Advise patient on good sleep hygiene before using hypnotics. If a patient has already been prescribed a benzodiazepine on the regular section at night, this would aid sleep therefore do not offer a hypnotic at the same time even if this is prescribed on the when required section. PRN hypnotics should only be administered after 11.30pm i.e. after the patient has gone to bed and has had the opportunity to fall asleep. Try not to administer hypnotics after 02.00am in order to reduce the occurrence of hangover effects the next day. Physical health should be monitored when patients suffer from a respiratory illness; respiratory rate and signs of excess sedation. Reviewing Hypnotic Use Hypnotics should be reviewed weekly by the multidisciplinary team with a view to a dose reduction as soon as possible. The continued appropriateness of the hypnotic should be questioned. Patients no longer requiring hypnotics should have their prescriptions cancelled. Consider alternatives to a hypnotic e.g. using a sedative antidepressant in depression rather than adding a hypnotic. On Discharge Hypnotic use should be reviewed prior to discharge. Unless it has been used long term, most patients should not have a hypnotic prescribed on discharge as they will be returning to familiar surroundings. For patients who have been on long-term treatment advice should be provided to both the patient and their GP on further dose reductions and cessation of therapy where Page 6 of 11
appropriate. If needed, the discharge summary should state clearly the duration of hypnotic use and clear instructions for the GP about continuation / discontinuation. Hypnotic use in older people The use of hypnotics in older people is associated with increased risk of hip fractures, falls and confusion. The NSF for Older People states that patients taking hypnotics are more liable to fall during the night and this has been shown to be the case with short-acting as well as long-acting benzodiazepines. Long-acting benzodiazepines are also associated with an increased risk of hip fracture. The risk of falls is highest immediately after starting a benzodiazepine and after one month of continuous use. The starting dose of zopiclone in the elderly is 3.75mg and should only be increased if necessary. 5 NICE Guidance The National Institute of Clinical Excellence (NICE) Guidance issued in April 2004 advises: Non-pharmacological measures should be tried in the first instance. The lowest effective dose is to be used. A single period of treatment should not exceed 4 weeks (this is inclusive of tapering off) as there is a potential to cause tolerance, dependence (physical and psychological) as well as withdrawal symptoms. Patients who have not responded to one hypnotic should not be prescribed any of the others. Switching between hypnotics is only advocated if an adverse effect has occurred directly related to the specific agent. All hypnotics should be used within their licensed therapeutic indications. The cheapest hypnotic should be prescribed. There is no compelling evidence of clinically useful difference between 'Z' drugs and the shorter acting benzodiazepines. Drug Drug Tariff Cost May 2015 Temazepam 10mg (28) 1.89 Zopiclone 7.5mg (28) 1.11 Summary A hypnotic should only be prescribed if considered essential for insomnia. If considered essential, prescribing of hypnotics should comply with licensed indications stated in the BNF and there should be clear documentation in the patient s clinical notes, including reason for initiation and weekly reviews.. Hypnotics should be discontinued as soon as clinically appropriate. The product with the lowest acquisition cost should be prescribed. Page 7 of 11
Training requirements associated with this Guideline Mandatory Training There is no mandatory training associated with this Guideline. Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual s training needs as defined within their annual appraisal or job description. How this Guideline will be monitored for compliance and effectiveness Aspect of compliance or effectiveness being monitored Method of monitoring Individual responsible for the monitoring Monitoring frequency Group or committee who receive the findings or report Group or committee or individual responsible for completing any actions Duties To be addressed by the monitoring activities below. Prescribing of hypnotics and use of nonpharmacological methods Audit of inpatient prescription charts on a single date Medical Director Every two years Medicines Management Committee Medicines Management Committee Where a lack of compliance is found, the identified group, committee or individual will identify required actions, allocate responsible leads, target completion dates and ensure an assurance report is represented showing how any gaps have been addressed. Equality considerations Refer to MMP001 Control of Medicines Policy. Reference Guide Committee on Safety of Medicines. Benzodiazepines, dependence and withdrawal symptoms. Current Problems 1988; 21:1-2. British National Formulary 72 September 2016 edition, pg 440 National Institute for Clinical Excellence. Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia. Technology Appraisal 77: April 2004 NHS Clinical Knowledge Summaries website. Insomnia - accessed 28/03/2017 Summary of Product Characteristics (Zopiclone) - Actavis UK Ltd. Accessed 28/03/2017 'Benzodiazepines in the elderly' Bandolier November 1996 'An update on benzodiazepines and non-benzodiazepine hypnotics' MeReC Briefing 17 April 2002 Page 8 of 11
Psychotropic Drug Directory Stephen Bazire 2012 Wilson et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders Journal Of Psychopharmacology 2010: 1-25 National Service Framework Medicines and older people: implementing medicines related aspects of the NSF for older people. London: Department of Health, 2001. Page 9 of 11
Document control details Author: Russell Parsons, Acting Chief Pharmacist Courtenay Pearson, Senior Pharmacist Mental Approved by and date: May 2017 Responsible committee: Medicines Management Committee Any other linked Policies: MMP001 Control of Medicines Policy Guideline number: MMG003 Version control: 1 Version No. Date Ratified/ Amended Date of Implementation Next Review Date 1 May 2017 May 2017 May 2019 Review Reason for Change (eg. full rewrite, amendment to reflect new legislation, updated flowchart, minor amendments, etc.) Page 10 of 11
Appendix 1 Patient Information Leaflet Nine hints and tips for a good nights sleep 1. The duration of sleep varies from day to day. Do not worry as you are bound to feel anxious the more you worry and this will make it harder for you to fall asleep. 2. If you have problems getting to sleep, try and relax, have a cup of warm milk or herbal tea, read a book, or listen to soothing music. 3. Avoid strenuous exercise just before you go to bed. Instead try relaxation techniques i.e. muscle relaxation exercises or yoga which can be helpful to reduce anxiety and to promote sleep. 4. Avoid caffeine-containing drinks (tea and coffee) or foods i.e. chocolates late in the evening, and heavy meals just before bedtime. 5. Avoid cigarette smoking late in the evening or if you are in bed and cannot sleep as this will make it more difficult for you to sleep because nicotine interferes with sleep as it is a stimulant. 6. Your bedroom should be comfortable, not too hot or cold and you should not have a television in the bedroom as this can stimulate your brain and keep you awake. 7. Keep the bedroom as dark as possible if external light disturbs your sleep, and turn lights off before sleep. 8. Ensure you have a routine for sleeping and waking up. 9. Avoid sleeping during the day as this will make it difficult for you to sleep at night except when you are not too well i.e. suffering from flu or cold. For further information contact Berrywood Pharmacy on 01604 685414 Page 11 of 11