1 these slides should be used in conjunction with the accompanying notes hypnotics

1These slides should be used in conjunction with the accompanying notes

Hypnotics

2 These slides should be used in conjunction with the accompanying notes

Options for local implementationNPC. 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


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?


Non-drug approachesClinical Knowledge Summaries. Last revised July 2009

Good sleep hygiene:• 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


MHRA advice on benzodiazepines in insomniaCSM. 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 insomniaSPCs 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.


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 benzodiazepinesWagner 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


Patient experience of hypnotics in primary careSiriwardena AN, et al. Br J Gen Pract 2008;58:417–22

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

Trends in prescribing of hypnotics in General Practice in England

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Zopiclone Temazepam Nitrazepam Zolpidem Lormetazepam Melatonin Others

© Copyright NHSBSA 2011

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Trends in spending on hypnotics in General Practice in England


Prescribing comparatorHypnotics ADQ/STAR PU

www.nhsbsa.nhs.uk/PrescriptionServices/3334.aspx

0.54

2.24

Quantities of selected hypnotics (tabs/caps)prescribed in General Practice in England

(Quarter to December 2010)

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Quantities on Prescriptions

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s

"Z" drugs Temazepam Nitrazepam

Z-drugs should be used in accordance with their licensed indication:

i.e. short-term use in insomnia

— up to 2 or 4 weeks



How can people who want to withdraw from hypnotics be supported?

• Older people are not always being given appropriate safety warnings about taking these drugsIliffe 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 availableNICE 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

1 these slides should be used in conjunction with the accompanying notes hypnotics

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