Benzodiazepines and Hypnotics Full Title of Guideline: Author (include email and role): Division & Speciality: Scope (Target audience, state if Trust wide): Review date (when this version goes out of date): Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis): Guideline for the use of Benzodiazepines and Hypnotics in the management of insomnia and anxiety disorders in adults Rowan Harwood, Consultant Physician HCOP Rowan.Harwood@nuh.nhs.uk Debbie Storer, pharmacist Deborah.storer@nuh.nhs.uk HCOP, Medicine Division This guideline provides advice relating to benzodiazepines and hypnotics in the management of insomnia and anxiety disorders in adult patients May 2020 Adult patients excluding rapid tranquillisation, alcohol detoxification, end of life care, movement disorders, spasticity management, IV sedation for procedures and epilepsy. Changes from previous version (not applicable if this is a new guideline, enter below if extensive): Summary of evidence base this guideline has been created from: This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date or outside of the Trust. Page 1 of 10
GUIDELINE FOR THE USE OF BENZODIAZEPINES AND HYPNOTICS IN THE MANAGEMENT OF INSOMNIA AND ANXIETY DISORDERS IN ADULTS 1.0 AIM OF POLICY 1.1 The aim of this guideline is to ensure that benzodiazepines and other hypnotic drugs used in the management of insomnia and anxiety disorders are prescribed appropriately and reviewed regularly to reduce the potential for side-effects and prevent dependence and withdrawal problems. 1.2 Commonly prescribed benzodiazepines for anxiety and / or insomnia include clonazepam, diazepam, lorazepam, nitrazepam and temazepam. Other hypnotics include the Z-hypnotics (e.g. zopiclone, zolpidem) See Table 1. 1.3 The use of benzodiazepines for rapid tranquillisation, alcohol detoxification, end of life care, movement disorders, spasticity management, IV sedation for procedures and epilepsy is not covered by this policy. Separate guidelines may be available for these indications. 2.0 BACKGROUND 2.1 The Committee on Safety of Medicines (CSM) 1 issued initial advice in 1988 which is still reflected in the BNF 2 as stated below and is incorporated within various mental health NICE guidelines 3,4,5. 1. Benzodiazepines are indicated for the short-term relief (two to four weeks only) of anxiety that is severe, disabling, or causing the patient unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic, or psychotic illness. 2. The use of benzodiazepines to treat short-term mild anxiety is inappropriate. 3. Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or causing the patient extreme distress. 2.2 Dependence (physical and psychological) and tolerance can occur if these drugs are taken continuously for more than a few weeks. The withdrawal syndrome is well known and includes symptoms such as insomnia, nightmares, perceptual disturbances, dizziness, anxiety, depression, nausea, vomiting, confusion and seizures. 2.3 Benzodiazepines are also associated with an increased risk of falls, particularly in the older patient, leading to increased morbidity. Of recent concern is suggestion that routine hypnotic use is linked with an increased risk of mortality 6,7. Page 2 of 10
2.4 Finally, chronic anxiety and insomnia are rarely benefited by long-term prescription of benzodiazepine and other hypnotic drugs. 3.0 PRESCRIBING GUIDELINES 3.1 Non-drug strategies and sleep hygiene advice (see Table 2) should always be considered as first-line approaches to managing anxiety and insomnia. 3.2 If there is an underlying condition such as pain, respiratory or cardiac disease then sleep problems are likely to improve when the condition has been adequately treated. Prior to initiating drug treatment for insomnia, consider and address the potential causes of the insomnia (e.g. depression, bipolar disorder, anxiety disorder or physical problems such as heartburn, pain or dyspnoea and other problems such as substance misuse). 3.3 Reassurance, counselling, guided self-help, relaxation techniques, anxiety management and psychological interventions (e.g. CBT) are important strategies for managing anxiety disorders and mild depression. Refer to the Department of Psychological Medicine / liaison psychiatry for advice. 3.4 Patients who have been admitted or referred to services and are already taking a long-term hypnotic or anxiolytic benzodiazepine 3.4.1 For each admission/referral determine whether the patient takes one or more of these drugs, regularly or intermittently for anxiety, insomnia or both. Part of the assessment process should be to review the patient s use of benzodiazepines and hypnotics and to decide whether their continued use is indicated. 3.4.2 Patients who have taken these drugs for longer than four weeks should not have this treatment stopped abruptly due to the risk of precipitating withdrawal symptoms. 3.4.3 Taking patients off long-term hypnotics or anxiolytic benzodiazepines should be planned and discontinuation should be gradual over at least 4-6 weeks (longer in some cases). In an in-patient supervised setting the period can be shortened. Page 3 of 10
3.5 Patients who do not currently take hypnotics or anxiolytic benzodiazepines 3.5.1 Consider first-line advice above (3.1-3.3). 3.5.2 When benzodiazepines or hypnotics are prescribed they should be reserved for short courses to alleviate severe, disabling symptoms. 3.5.3 If a prescription is required it should be limited to a short time period (up to 7 days initially) as PRN (when required) and then reviewed. Try to start with the lowest licensed dose. A review/stop date should be stated clearly on the prescription. 3.5.4 Nursing and pharmacy staff should check with the prescriber if it continues to be administered/requested after the stated review period. 3.5.5 Intermittent use of hypnotics (every 2 nd /3 rd night) can help prevent tolerance developing. Explain to the patient the limitations of sleeping tablets. 3.5.6 Ideally, hypnotics should not be given/taken before midnight (to give the patient an opportunity to get to sleep without them). 3.5.7 In patients leave/discharge TTOs Prescribers should review and aim to reduce or stop short-term benzodiazepine or hypnotics prior to discharge. The prescriber should carefully consider if PRN benzodiazepine or hypnotics are still necessary for periods of leave or on discharge. If they are prescribed, the exact quantity to be supplied should be stated based on recent and likely usage. The minimum quantity should always be prescribed. If patients are discharged back to primary care on hypnotics or anxiolytic benzodiazepines then the discharge summary should clearly state the likely duration of treatment and when this should be reviewed and stopped by the GP. Pharmacy will aim to confirm with the prescriber all discharge prescriptions for benzodiazepines and other hypnotic drugs where it is known that the patient was not taking these drugs prior to their hospital admission. Page 4 of 10
3.5.8 Out-Patient Prescriptions All repeat prescriptions on Out-Patient drug charts should be reviewed regularly by the prescribing team to assess continuing need. All those involved in a patient s care (e.g. carers and pharmacy) can play a valuable role in identifying chronic use of these drugs and bringing this to the attention of the prescribing team. 3.6 Exceptionally, it is recognised that there may be occasions where patients with severely disabling symptoms are prescribed longer courses of these drugs under the supervision of a consultant/senior colleague. 3.7 The elderly, frail and those with hepatic impairment are particularly sensitive to the adverse effects of these drugs e.g. ataxia, dysarthria, confusional states and falls. Lower doses (¼-½ adult dose) of the shorter-acting drugs are preferred. 3.8 NICE 5 recommends that because of a lack of compelling evidence to distinguish between the Z-hypnotics or the shorter-acting benzodiazepine hypnotics, the drug with the lowest purchase cost (taking into account daily required dose and product price per dose) should be prescribed. This is currently zopiclone. Switching from one Z-hypnotic to another should only occur if a patient experiences adverse effects considered to be directly related to the specific agent. Patients who have not responded to one Z-hypnotic should not be prescribed any of the others. Prescribers are reminded that the maximum licensed dose of zopiclone for an adult is 7.5mg at night or 3.75-7.5mg at night for the elderly. Z-hypnotics, like the benzodiazepines, are liable to abuse, dependence and withdrawal following long term use. 4.0 MONITORING THIS POLICY 4.1 It is recommended that clinical teams regularly audit their prescribing of benzodiazepines and other hypnotic drugs under the umbrella of their divisional clinical governance structures. Page 5 of 10
TABLE 1: COMPARISON OF BENZODIAZEPINES AND Z-HYPNOTICS * This table does not provide data on dose equivalence between drugs. For debilitated patients or elderly patients lower doses (e.g. half adult doses) are recommended. See the medication s Summary of Product Characteristics (SPC) for further information. ** Half-life does vary between patients and can be longer in certain patient groups (e.g. renal impairment, elderly) *** Use outside of a product s marketing authorisation (e.g. off label use) should be in accordance with the Trust s Unlicensed Medicines Policy (part of the medicines code of practice). Drug (in alphabetical order) Clonazepam Diazepam Lorazepam Usual adult dose for anxiety (per day)* Severe anxiety 0.5mg - 1mg up to two or three times a day 2mg TDS increased if necessary to 15-30mg in divided doses 1-4mg in divided doses Usual adult dose for insomnia (per day)* Approximate Half Life** - 20-60 hrs (mean = 30 hrs) Insomnia associated with anxiety 5-15mg before bed Insomnia associated with anxiety 1-2mg before bed Nitrazepam - 5-10mg before bed Temazepam - 10-20mg before bed 24-48 hrs (2-5 days for active metabolite) 12 hrs Other information Off label*** use for anxiety 24 hrs Half-life increased in elderly (~40hrs) Non-Formulary in Nottinghamshire 8-15 hrs Dose can be increased in exceptional circumstances. Store in CD cupboard Table continued overleaf Page 6 of 10
Drug (in alphabetical order) Usual adult dose for anxiety (per day)* Usual adult dose for insomnia (per day)* Zopiclone - 7.5mg before bed Zolpidem - 10mg before bed Approximate Half Life** Other information 4-6 hrs Slower onset than zolpidem but longer action mean = 2.4 hrs Potent and quick acting (usually works within 15 mins) useful for initiating sleep TABLE 2: SLEEP HYGEINE Listed below are 10 rules of sleep hygiene. An explanation of why each is important is available in the Managing Insomnia and Sleep Problems booklet 8. 1. Discontinue caffeine use 4 hours before bedtime 2. If you smoke, avoid smoking around bedtime and when you wake up during the night 3. Be careful with alcohol at bedtime; it may help you get to sleep, but it can also wake you up later in the night 4. A light snack at bedtime may promote sleep - but avoid heavy meals 5. Avoid vigorous exercise within two hours of bedtime 6. Keep your bedroom calm and comfortable 7. Keep your bedroom temperature comfortable 8. Minimise noise and light in the bedroom but take advantage of light during the day 9. Keep your bedroom mainly for sleeping; try to avoid watching television, listening to the radio, or eating in your bedroom 10. Try to keep regular bedtimes and personal schedules Page 7 of 10
5.0 REFERENCES 1. CSM Current Problems 1988, 21, 1-2. http://webarchive.nationalarchives.gov.uk/20141205150130/http:/www.mhra.g ov.uk/home/groups/pl-p/documents/websiteresources/con2024428.pdf 2. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press <http://www.medicinescomplete.com> [Accessed on 03/2017] 3. NICE Guidance CG 90/91. Depression in adults: recognition and management. / Depression in adults with a chronic physical health problem: recognition and management October 2009. http://www.nice.org.uk/ 4. NICE Guidance CG 113. Generalised anxiety disorder and panic disorder in adults: management. January 2011. www.nice.org.uk/guidance/cg113 5. NICE TA77. Guidance on the use of zaleplon, zolpidem and zopiclone for the short term management of insomnia. April 2004. www.nice.org.uk/guidance/ta77 6. MeReC Rapid Review (2012). Hypnotics associated with increased mortality, even in patients taking fewer than 18 doses/year. https://www.centreformedicinesoptimisation.co.uk/hypnotics-associated-withincreased-mortality-even-in-patients-taking-fewer-than-18-dosesyear/ 7. Belleville G. (2010). Mortality Hazard Associated with Anxiolytic and Hypnotic Drug Use in the National Population Health Survey, CANADIAN JOURNAL OF PSYCHIATRY, 55(9), p558-567. http://www.cpa-apc.org/index.php 8. Nottinghamshire Healthcare NHS Trust. Managing Insomnia and Sleep Problems. https://www.nuh.nhs.uk/media/2237861/managing_insomnia_and_sleep_probl ems_booklet.pdf [Accessed on 03/05/2017] 9. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders https://www.bap.org.uk/pdfs/bap_guidelines-sleep.pdf Page 8 of 10
Equality Impact Assessment Report 1. Name of Policy or Service Trust wide clinical guidance 2. Responsible Manager Owen Bennett (Clinical Quality, Risk and Safety Manager) 3. Name of person Completing EIA Rowan Harwood / Debbie Storer 4. Date EIA Completed May 2017 5. Description and Aims of Policy/Service This guideline has been written to assist hospital staff in the management of adult patients with insomnia or anxiety 6. Brief Summary of Research and Relevant Data Full references provided on document 7. Methods and Outcome of Consultation Drugs and Therapeutics Committee 8. Results of Initial Screening or Full Equality Impact Assessment: Equality Group Age Gender Race Sexual Orientation Religion or belief Disability Assessment of Impact Dignity and Human Rights Working Patterns Social Deprivation Page 9 of 10
9. Decisions and/or Recommendations (including supporting rationale) From the information contained in the procedure, and following the initial screening, it is our decision that a full assessment is not required at the present time. 10. Equality Action Plan (if required) N/A 11. Monitoring and Review Arrangements Review May 2020 Page 10 of 10