HYPNOTICS – Reducing & Stopping Medicine Optimisation HYPNOTICS – Reducing & Stopping The slides have been adapted from the NPC slide set available at http://www.npc.nhs.uk/qipp/qipp_elearning/hypnotics_elearning.php

Options for local implementation NPC Options for local implementation NPC. Key therapeutic topics – Medicines management options for local implementation. Second update July 2011 Practices to review and, where appropriate, revise prescribing of hypnotics to ensure that it is in line with national guidance

Key questions What are the recommendations on hypnotics? What are the risks and benefits of hypnotics? Do Z-drugs have advantages over benzodiazepine hypnotics? How are we doing with prescribing? How can people who want to withdraw from hypnotics be supported?

Problems associated with the long-term use of benzodiazepines Adverse effects Drowsiness and falls Impairment in judgement and dexterity Increased risk of experiencing a road traffic accident Forgetfulness, confusion, irritability, aggression and paradoxical disinhibition Complications related to long-term use Depression Reduction in coping skills Tolerance and dependence

Dependence (one or more of following) Patients gradually ‘need’ benzodiazepines to carry out normal day-to-day activities Patients continue to take benzodiazepines although the original indication for the prescription is no longer relevant Patients have difficulty stopping treatment or reducing dosage due to withdrawal symptoms Short acting benzodiazepines may cause patients to develop anxiety symptoms between doses Patients contact their doctor regularly to obtain repeat prescriptions Patients become anxious if the next prescription is not readily available Patients may increase the dosage stated in the original prescription Despite benzodiazepine therapy, patients may present with recurring anxiety symptoms, panic, agoraphobia, insomnia, depression and an increase in physical symptoms of anxiety

Insomnia A common disorder characterised by unsatisfactory sleep (sleep onset, sleep maintenance, early waking) Predominantly a long-term disorder Before treatment rule out any potential causes of insomnia External factors (light, noise, room temperature) Change in sleep environment (e.g. hotel) Physiological disturbance (e.g. shift work, daytime napping) Jet lag Acute illness Psychological factors (e.g. anxiety, depression, stressful life events) Substance misuse and drug withdrawal Stimulant use (e.g. caffeine, nicotine, OTC or prescribed medicines) Perform sleep assessment (& anxiety rating)

Non-drug approaches Clinical Knowledge Summaries Non-drug approaches Clinical Knowledge Summaries. Last revised July 2009 CBT (Cognitive Behaviour Therapy) Good sleep hygiene Regular exercise Relaxation

MHRA advice on benzodiazepines in insomnia (CSM MHRA advice on benzodiazepines in insomnia (CSM. Curr Problems Pharmacovigilance. January 1988, No. 21) Should be used only if insomnia is severe, disabling or subjecting the patient to extreme distress Use lowest dose, for maximum of four weeks Use intermittently, if possible, for insomnia Taper off gradually

NICE guidance: newer hypnotics (Z-drugs) NICE technology appraisal 77, April 2004 No compelling evidence of a clinically useful difference between the Z-drugs and shorter-acting benzodiazepines from the point of view of their effectiveness, adverse effects, or potential for dependence or abuse The drug with the lowest purchase cost should be prescribed Switching from one of these hypnotics to another should only occur if a patient experiences adverse effects considered to be directly related to a specific agent. These are the only circumstances in which the drugs with the higher acquisition costs are recommended Patients who have not responded to one of these hypnotic drugs should not be prescribed any of the others.

Hypnotics for insomnia SPCs for zopiclone, zolpidem, zaleplon; www Hypnotics for insomnia SPCs for zopiclone, zolpidem, zaleplon; www.medicines.org.uk Zopiclone, Zolpidem Short–term treatment of insomnia…in situations where the insomnia is debilitating or is causing severe distress for the patient Long–term continuous use is not recommended The duration of treatment should be limited to 4 weeks, including any tapering off Zaleplon A single course of treatment should not continue for longer than 2 weeks

  What would happen to 13 people like you who take sleeping tablets for more than a week Glass J, et al. BMJ 2005;331:1169 The hypnotic makes no difference to what happens to these 12 people. Their sleep improves, or doesn’t improve, just as if they had taken placebo. This person finds his/her sleep improves, who would not have done had he or she taken the placebo  These 2 people have an adverse event, who would not have done had they taken the placebo. The hypnotic makes no difference to what happens to these 11 people. They have adverse events, or don’t have adverse events, just as if they had taken placebo.  These slides should be used in conjunction with the accompanying notes

Increased risk of road traffic accidents Gustavsen I, et al Increased risk of road traffic accidents Gustavsen I, et al. Sleep Med 2008;9:818–22 www.npc.nhs.uk/rapidreview/?p=249 Cohort study of Norwegian drivers, aged 18 to 69 years People prescribed zopiclone or zolpidem had double the risk of road traffic accidents (RTAs), compared with people not prescribed hypnotics Standardised incidence ratio (SIR) of hypnotic use in previous 7 days, compared with no use: Zopiclone or zolpidem — SIR 2.3 (95%CI 2.0 to 2.7) Nitrazepam — SIR 2.7 (95%CI 1.8 to 3.9) Flunitrazepam — SIR 4.0 (95%CI 2.4 to 6.4) Absolute rates (per exposed 1000 person-years) of RTAs were: about 5 to 9 accidents in groups treated with hypnotics about 2 accidents in the group not exposed to hypnotics

Hip fractures and benzodiazepines Wagner AK, et al Hip fractures and benzodiazepines Wagner AK, et al. Arch Intern Med 2004;164:1567–72 Incident relative risk of hip fracture with benzodiazepine (BZD) vs. no BZD use based on US claims data (194,071 person years of data, 1988-90): Any BZD exposure: 1.24 (95%CI 1.06 to 1.44) Long half-life BZD only: 1.13 (0.82 to 1.55) NS Short half-life high potency: 1.27 (1.01 to 1.59) Short half-life low potency: 1.22 (0.89 to 1.67) NS >1 BZD type: 1.53 (0.92 to 2.53) NS New BZD <16 days: 2.05 (1.28 to 3.28) New BZD 16–30 days: 1.88 (1.15 to 3.07) Continued BZD: 1.18 (1.03 to 1.35) NS – No significant difference Authors conclude: incidence of hip fracture appears to be associated with benzodiazepine use Note: Different doses were not considered

Hypnotic QIPP data Q4 2012 -13 (Cumbria, Northumbria, Tyne & Wear)

Hypnotic QIPP data Q4 2012 -13 (Cumbria Practices)

How can people who want to withdraw from hypnotics be supported? Older people are not always being given appropriate safety warnings about taking these drugs Iliffe S, et al. Aging Ment Health 2004;8:242–8 It is difficult to withdraw from hypnotic drugs A letter from the GP can be effective in helping some to stop Cormack MA, et al. Br J Gen Pract 1994;44:5–8 CBT can be helpful Morgan K, et al. HTA 2004:8(8) See CKS guidance for further information Published criteria for clinical audit are available NICE TA77, April 2004; Shaw E, Baker R. J Clin Governance 2001;9:45–50

Key messages Non-drug treatments should be considered and used routinely in all patients 1988 CSM advice re benzodiazepines still stands and is also applicable to Z-drugs NICE guidance confirms that Z-drugs offer little or no advantage over benzodiazepines However, overall prescribing of hypnotics is not decreasing Hypnotics should be used at lowest dose for max 4 weeks for severe insomnia only Consider auditing hypnotic use and changing practice Resources exist for managing withdrawal

Suggested Practice Actions(1) All prescribers must agree to be engaged and involved with the project Circulate to all prescribers the Welsh information pack, which containers sample letters, sleep guides, reduction schedules etc. - email to all prescribers - electronic copy on surgery information folder - hard copy to be kept by medicine manager- easily accessible for reference - decide which parts are useful – print off? Identify patients who receive hypnotics on repeat and acute - Medicine Mangers to search for last 12 months Establish the demographics of patients - who to look at first? Younger patients? (may be diverting supplies. If don’t stop now, may have many years of benzo use ahead of them) Elderly patients? (at greater risks of falls, maybe on older medicines e.g. nitrazepam) Patients on high doses? Middle aged group?

Suggested Practice Actions(2) Patient selection - For each prescriber, a list of patients to be produced, based on which GP has seen the patient last or is most familiar with a patient. GPs can do ‘swaps’, if they wish! Need to make sure the numbers are divided fairly equally. - GP to go through the list, and eliminate anyone who has a genuine reason for being on the drug, or feel would be too difficult a challenge to start with. - GPs to identify one or two patients to call in for a medication review to discuss the issue, and start reducing the dose. (method to be decided) Each month, one or two more patients selected. This is a gradual process - the numbers will build up slowly but steadily, depending on the workload created by withdrawing patients. Some patients may be deemed too difficult to stop completely but even a reduction in dose or a switch to a shorter acting drug is preferable to doing nothing. The reduction method should be discussed and tailored to each individual patients needs converting to equivalent diazepam dose, and reducing slowly reducing the dose of the drug gradually reducing the number of tablets supplied for a set time period i.e. having drug free nights e.g. 25 tablets lasting 28 days etc. The patient needs to see the same GP during the reduction schedule, especially if the patient is requesting the dose to be increased back up.

Suggested Practice Actions(3) New Patients prescribed hypnotics - only prescribe if absolutely clinically essential - seven days supply only, as an acute script (Good Practice) - label as ‘ one at night, if required’ - zopiclone = Lothian Joint Formulary 2nd choice (1st choice = no treatment) - give patient ‘Good sleep guide/Good relaxation guide’ - no repeat prescriptions for new patients At prescribing meetings within the practice, suggest analysing prescribing of hypnotics within the last 3 months to determine if any patients have been commenced and continued on hypnotics, and the reasons why. Transferred patients - Any new patients registering with the practice from another surgery on hypnotics will have their medication discussed and reviewed at their initial consultation. The message that the patient needs to reduce, and eventually stop, their use of these drugs should be re-enforced at every opportunity. Involvement of the drug and alcohol service should be considered.

Support Material Cumbria GP Practice guide Welsh Education Pack Presentation Hypnotic Academic Detailing Aid The Good Sleep Guide The Good Relaxation Guide Patient letters Reduction Protocols Community Pharmacy support

Fiona Gunston, Lynne Palmer, Judi Matthews & Jim Loudon Prepared by Fiona Gunston, Lynne Palmer, Judi Matthews & Jim Loudon Medicines Optimisation Pharmacists for NHS Cumbria Clinical Commissioning Group North of England Commissioning Support (NECS) Using slides and notes provided by NPC (National Prescribing Centre)