Date of preparation March 2010 Insomnia Key slides

Insomnia NICE TA 77, April 2004; CKS (Prodigy), July 2006; DTB 2004 Date of preparation March 2010 Insomnia: difficulty initiating sleep and/or difficulty maintaining sleep Prevalence: estimates vary from 10% - 48% Higher in women, with increasing age and in those with concurrent physical or mental health conditions Primary insomnia: Unknown origin or arising from sleep environment, irregular sleep routine, or negative conditioning to sleep Secondary insomnia: Underlying psychological or physical condition, prescribed/OTC medicines, caffeine or substance misuse Important to avoid unrealistic sleep expectations For all people with insomnia, offer advice on good sleep hygiene and stimulus control Also consider exercise, relaxation therapies, etc.

Non-drug approaches CKS (Prodigy), July 2006 Date of preparation March 2010 Non-drug approaches CKS (Prodigy), July 2006 Sleep hygiene: Avoid caffeine and nicotine 6 hours before bed time Avoid alcohol around bedtime (alcohol may encourage sleep onset but tends to fragment sleep) Avoid heavy meals before sleep (although a light meal may be helpful) Avoid exercise within 4 hours of bedtime (although exercise earlier in the day is beneficial) Minimise noise, light and excessive heat during the sleep period. Stimulus control measures: Only go to bed when sleepy Only use the bed for sleeping and sex Leave the bedroom if not asleep within 15–20 minutes and go back to bed only when feeling sleepy again Get up at a fixed time in the morning, regardless of the amount of sleep achieved the previous night Avoid sleep during the day.

Date of preparation March 2010 Hypnotics for insomnia CSM, Curr Problems Pharmacovigilance January 1988, No. 21 SPCs for zopiclone, zolpidem, zaleplon accessed from emc.medicines.org.uk, July 2008 Benzodiazepines should be used only if insomnia is severe, disabling or subjecting the patient to extreme distress Use lowest dose, for maximum of 4 weeks Use intermittently, if possible Taper off gradually 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 Treatment duration: a single course of treatment should not continue for longer than 4 weeks including any tapering off Zaleplon Treatment duration: a single course of treatment should not continue for longer than 2 weeks.

NICE guidance: newer hypnotics (Z-drugs) NICE TA 77, April 2004 Date of preparation March 2010 NICE guidance: newer hypnotics (Z-drugs) NICE TA 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.

  Date of preparation March 2010 What would happen to 13 people 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. 

Road traffic accidents and benzodiazepines Bandolier 1998;57:5 (Hemmelgarn B, et al. JAMA 1997;278:27-31) Date of preparation March 2010 Risks of RTA in Quebec 1990-93 Short half-life benzos: RR 0.96 (95%CI 0.88 to 1.05) NS Long half-life benzos: RR 1.28 (95%CI 1.12 to 1.45), higher risk in first week

Date of preparation March 2010 Hip fractures and benzodiazepines Wagner AK, et al. Arch Intern Med 2004;164:1567–72 Incident RR of hip fracture with 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) Authors conclude: incidence of hip fracture appears to be associated with benzodiazepine use. Note: Different doses were not considered.

Other issues Date of preparation March 2010 Some GPs have misperceptions about the safety and efficacy of Z-drugs compared to benzodiazepines Siriwardena AN, et al. Br J Gen Pract 2006;56:964–7 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 Shaw E, Baker R. Journal Clin Governance 2001;9:45-50, NICE TA 77, April 2004

Date of preparation March 2010 Trends in prescribing of hypnotics in general practice in England NHSBSA, September 2009

Summary of key messages Date of preparation March 2010 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 benzodiazepines and Z-drugs is not decreasing Long-term use of hypnotics is ‘off-label’ and is contrary to all available evidence and guidance Think about auditing benzodiazepine and Z-drug use and changing practice Resources exist for managing withdrawal No evidence that new melatonin receptor agonists offer advantages over existing hypnotics.