Hypnotics 1 These slides should be used in conjunction with the accompanying notes Options for local implementation NPC. Key therapeutic topics Medicines management options for local implementation. Second update July 2011 Review and, where appropriate, revise prescribing of hypnotics to ensure that it is in line with national guidance 2 These slides should be used in conjunction with the accompanying notes 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? 3 These slides should be used in conjunction with the accompanying notes
Non-drug approaches Clinical Knowledge Summaries. Last revised July 2009 Good sleep hygiene: 4 Establish fixed times for going to bed and waking up (and avoid sleeping in after a poor night's sleep) Try to relax before going to bed Maintain a comfortable sleeping environment: not too hot, cold, noisy, or bright Avoid napping during the day Avoid caffeine, nicotine, and alcohol within 6 hours of going to bed Consider complete elimination of caffeine from the diet Avoid exercise within 4 hours of bedtime (although exercise earlier in the day is beneficial) Avoid eating a heavy meal late at night Avoid watching or checking the clock throughout the night Only use the bedroom for sleep and sexual activity
These slides should be used in conjunction with the accompanying notes 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 5 These slides should be used in conjunction with the accompanying notes 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. 6 These slides should be used in conjunction with the accompanying notes Hypnotics for insomnia SPCs for zopiclone, zolpidem, zaleplon; www.medicines.org.uk Zopiclone, Zolpidem Shortterm treatment of insomniain situations where the insomnia is debilitating or is causing severe distress for the patient Longterm 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 7 These slides should be used in conjunction with the accompanying notes 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 doesnt 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 The hypnotic makes no difference to what happens to these 11 people. They have adverse events, or dont have adverse events, just as if they had taken placebo. 8 These 2 people have an adverse event, who would not have done had they taken the placebo. These slides should be used in conjunction with the accompanying notes Increased risk of road traffic accidents Gustavsen I, et al. Sleep Med 2008;9:81822 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 9 These slides should be used in conjunction with the accompanying notes Hip fractures and benzodiazepines Wagner AK, et al. Arch Intern Med 2004;164:156772
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 1630 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 10
These slides should be used in conjunction with the accompanying notes Patient experience of hypnotics in primary care Siriwardena AN, et al. Br J Gen Pract 2008;58:41722 www.npc.nhs.uk/rapidreview/?p=164 Questionnaire study of patients who had taken hypnotics in last 6 months (705 respondents) Repeat prescriptions accounted for 92.1% of all hypnotic prescriptions, with 67.4% taking daily medication 42.3% had not been advised regarding duration of treatment and of those who had received guidance 45.4% were advised to continue treatment longer than licensed recommendations However, 87% felt their insomnia had improved on medication, 72.1% wanting to continue treatment The study reported no advantage for the Z-drugs over benzodiazepines either in helping them sleep or in causing fewer adverse effects. Prescribing practices were often contrary to both the NICE guidance and the product licence 11 These slides should be used in conjunction with the accompanying notes Trends in prescribing of hypnotics in General Practice in England 3,000,000 2,500,000
Hypnotics ADQ/STAR PU www.nhsbsa.nhs.uk/PrescriptionServices/3334.aspx 2.24 0.54 14 These slides should be used in conjunction with the accompanying notes Quantities of selected hypnotics (tabs/caps) prescribed in General Practice in England (Quarter to December 2010) 800,000 "Z" drugs Temazepam Nitrazepam 700,000 Z-drugs should be used in accordance with their licensed indication: 600,000 Items
500,000 i.e. short-term use in insomnia 400,000 up to 2 or 4 weeks 300,000 200,000 100,000 0 > 84 78 to 84 71 to 77 64 to 70 Copyright NHSBSA 2011 57 to 63 50 to 56 43 to 49 36 to 42 29 to 35
22 to 28 15 to 21 8 to 14 1 to 7 Quantities on Prescriptions 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;8:2428 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;44:58 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;9:4550 16
These slides should be used in conjunction with the accompanying notes 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 17 These slides should be used in conjunction with the accompanying notes
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