Hypnotic Drugs. Trends in Prescribing of Hypnotics in General Practice in England (Chart 1)

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1 Hypnotic Drugs Insomnia is a disturbance of normal sleep patterns commonly characterised by difficulty in initiating sleep (sleep onset latency) and / or difficulty in maintaining sleep (sleep maintenance). 1 The prevalence of insomnia has been estimated to be between 10 and 48% and has been reported to be higher in women, with increasing age and in those with concurrent physical or mental health conditions. 2 NHS Clinical Knowledge Summaries (CKS) recommend the early identification and management of any psychiatric or medical comorbid disorder as essential as up to 80% of insomnia is associated with a comorbidity. 3 For all people with insomnia, healthcare professionals should first offer advice on good sleep hygiene and stimulus control: 3 Avoid caffeine, nicotine and alcohol within 6 hours of going to bed (alcohol may encourage sleep onset but tends to fragment sleep) Exercise regularly during the day but not within a few hours of bedtime Avoid large meals before bedtime, although a light snack may be helpful Get up at the same time each day regardless of the amount of sleep achieved the previous night and avoid sleep in the day Avoid using the bedroom for working or for watching television Maintain a comfortable sleeping environment: not too hot, cold, noisy or bright Avoid watching or checking the clock throughout the night Try to relax before going to bed 3.0 Trends in Prescribing of Hypnotics in General Practice in England (Chart 1) 2.5 Items (Millions) Quarter to Sep-05 Dec-05 Mar-06 Jun-06 Sep-06 Dec-06 Mar-07 Jun-07 Sep-07 Dec-07 Mar-08 Jun-08 Sep-08 Dec-08 Mar-09 Jun-09 Sep-09 Dec-09 Mar-10 Jun-10 Sep-10 Temazepam Zopiclone Nitrazepam Zolpidem Lormetazepam Melatonin Others

2 12 Trends in Spending on Hypnotics in General Practice in England (Chart 2) 10 NIC ( Millions) Quarter to Sep-05 Dec-05 Mar-06 Jun-06 Sep-06 Dec-06 Mar-07 Jun-07 Sep-07 Dec-07 Mar-08 Jun-08 Sep-08 Dec-08 Mar-09 Jun-09 Sep-09 Dec-09 Mar-10 Jun-10 Sep-10 Temazepam Zopiclone Nitrazepam Zolpidem Lormetazepam Melatonin Others Hypnotics used for the management of insomnia include; benzodiazepines, the commonly called Z-drugs - zaleplon, zolpidem and zopiclone which act on the benzodiazepine receptor; and drugs acting on the melatonin receptor. The risks associated with the long term use of hypnotic drugs have been well recognised for many years but the overall prescribing is not decreasing (chart 1). In the quarter to September 2010 the prescribing of hypnotics (BNF chapter 4.1.1) was 2.6 million items, an increase of 5% in the last five years. In the same time frame the spending has doubled to 10.9 million. Sedative drugs such as tricyclic antidepressants, antihistamines, chloral hydrate, clomethiazole and barbiturates are not recommended for the management of insomnia by CKS. In 1988 the Committee on Safety of Medicines advised that benzodiazepine hypnotics should be used only if the insomnia was severe, disabling or causing the patient extreme distress. The lowest dose that controls symptoms should be used for a maximum of four weeks and intermittently if possible. In addition a gradual tapering off towards the end of the course of treatment in order to avoid rebound insomnia and withdrawal effects is recommended. 4 In April 2004 the National Institute for Health and Clinical Excellence (NICE) provided guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia 1 and advised: 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 cost are recommended

3 Patients who have not responded to one of these hypnotic drugs should not be prescribed any of the others NICE recommend that hypnotics should be prescribed for short periods of time only, in strict accordance with their licensed indications, when insomnia is severe and interfering with normal daily life and the usual non-pharmacological measures have been considered. Chart 3 shows the quantity of nitrazepam, temazepam and Z-drugs prescribed on FP10 prescriptions in primary care for the quarter to September Although there has been a reduction in the percentage of prescriptions for quantities of more than 28 tablets/capsules compared to the same quarter four years ago (September 2006) there were still 32% of all prescriptions for nitrazepam for a quantity of 29+ (compared to 39% four years ago), 21% of all prescriptions for temazepam (compared to 27%) and 11% of all prescriptions for Z-drugs (compared to 13%). This suggests that the duration of supply of prescribed hypnotics is commonly 4 weeks or longer. A report from the NHS Information Centre assessed the variation in use of 26 medicines positively approved by NICE in 13 technology appraisals which included the Z-drugs for the short term management of insomnia. 5 The report provides a comparison of England and Strategic Health Authority predicted versus observed uptake of medicines expressed as defined daily doses (DDD). The prescribing of Z- drugs, per expected patient by PCT in 2008, ranged from about 2 to 16 times (average 7.4) of the expected use of 28 DDDs (four weeks supply). The report suggested that the reclassification of temazepam as a controlled drug may have led to increased prescribing of the Z-drugs. Quantities of Selected Hypnotics (Tabs/Caps) Prescribed in General Practice in England (Quarter to September 2010) (Chart 3) 800, ,000 "Z" drugs Temazepam Nitrazepam 600, ,000 Items 400, , , ,000 0 > to to to to to to to to to to 21 8 to 14 1 to 7 Quantities on Prescriptions In 2005 the results of a meta-analysis (24 RCTs, n =2,417) 6 looking at the potential benefits and risks of hypnotics in people aged 60 years or more with primary insomnia who took hypnotics for at least 5 consecutive nights concluded that these drugs confer only a modest benefit in a small minority of people at the expense of a greater number of side effects. Whilst there were limitations in this meta-analysis the numbers needed

4 to treat (NNT) and the numbers needed to harm (NNH) are represented pictorially as a decision aid to assist health professionals in consultations explain the harms and benefits of hypnotic treatment to patients and are available to download from the patient decision aid rooms on the insomnia and mental health floor of the NPCi: In addition leaflets for patients explaining the causes, symptoms and prevention of insomnia can be found on the CKS website; A further meta-analysis of RCTs in considered the efficacy and safety of drugs for chronic insomnia in adults (benzodiazepines 52 RCTs, Z-drugs 48 RCTs and antidepressants 8 RCTs). Sleep onset latency was significantly decreased, but only a small average improvement was achieved. When measured by polysomnography the weighted mean difference was: Benzodiazepines: minutes (95% CI to -3.4), Z-drugs: minutes (95% CI to -8.8), Antidepressants: -7.0 minutes (95% CI to -3.3) When assessed by sleep diaries the weighted mean difference was: Benzodiazepines: minutes (95% CI to -15.3), Z-drugs: minutes (95% CI to -14.0), Antidepressants: minutes (95% CI to -2.2). Melatonin is a hormone produced by the pineal gland that regulates circadian rhythms and sleep. In 2008 a prolonged-release 2mg tablet (Circadin ) was licensed for the short-term monotherapy treatment of primary insomnia in patients aged 55 years or older. In 2008, a review by the National Prescribing Centre (NPC) of modified-release melatonin for the short term treatment of primary insomnia, concluded that there was a lack of evidence to demonstrate clinically significant benefits over prescription hypnotics. 8 In the summer of 2010 the licensed recommended duration of treatment of Circadin was increased from three weeks to up to thirteen weeks. 9 In the last two years prescribing of and spending on melatonin has more than doubled to 44,000 items ( 3.4 million). Two years ago (quarter to September 2008) licensed melatonin accounted for 5% of prescribing of all melatonin (1,000 items) and 1% of the cost ( 15,000). At present licensed melatonin (quarter to September 2010) accounts for 33% of prescribing (14,000 items) of all melatonin and 10% of the cost ( 350,000). The most commonly prescribed melatonin presentation is the generically written licensed preparation, melatonin 2mg m/r tablets, at 8,800 items costing 210,000 with the brand Circadin at 5,400 items, ( 140,000) with an average cost per prescription of around 25. The second most commonly prescribed presentation is the unlicensed melatonin 3mg capsules 6,500 items costing 611,000 and an average cost per prescription of 94, followed by melatonin 2mg capsules 5,800 items costing 603,000 (average cost per prescription 104). Prescribing of the melatonin 5mg/5ml liquid special is 4,400 items costing 708,000 (average cost per prescription of over 160). Prescribing Data (Reporting quarter = July-September 2010, Index quarter = July- September 2005) Prescribing of Z-drugs (zaleplon, zolpidem and zopiclone) has increased by 33% to 1.5 million items whereas costs have fallen 16% to 2.5 million. Z-drugs account for 59% of prescribing of hypnotics (BNF 4.1.1) and 23% of the cost. Prescribing of benzodiazepines (nitrazepam, temazepam, loprazolam, lormetazepam and

5 flurazepam) has fallen by 22% to 993,000 items whilst the cost has more than doubled to 4.5 million. These drugs represent 39% of all prescribing of hypnotics and 41% of the cost. The most commonly prescribed hypnotic is zopiclone which has increased by 38% over the last 5 years to 1.3 million items at a cost of 2.2 million (a fall of 11%). Prescribing of temazepam has fallen by 18% to 700,000 items whilst costs have risen 169% to 2.7 million. Prescribing of nitrazepam fell by 25% to 257,000 with costs falling by just 3% to 393,000. Zolpidem accounts for 185,000 items (an increase of 11%) and 321,000 (a 36% decrease). Prescribing of lormetazepam has fallen by 61% to 15,000 items whereas the cost has tripled to 936,000. Cost for 7 Days ( ) Temazepam 1 x 20mg tab at night 0.55 Zopiclone 1 x 7.5mg tab at night 0.34 Nitrazepam 1 x 5mg tab at night 0.24 Zolpidem 1 x 10mg tab at night 0.36 Lormetazepam 1 x 1mg tab at night Circadin 1 x 2mg mr tab at night 3.59 Loprazolam 1 x 1mg tab at night 4.50 Zaleplon 1 x 10mg cap at night Cost ( ) Prices based on Drug Tariff February 2011 and the NHS dictionary of medicines and devices. Dose based on WHO DDDs where possible, otherwise BNF stated dose. The WHO DDD is a unit of measurement based on the assumed average maintenance dose in adults. It may not necessarily reflect the actual dose used.

6 1. NICE. Guidance on the use of zaleplon, zolpidem, and zopiclone for the shortterm management of insomnia. Technology Appraisal 77; April NPCi CKS. Insomnia. Clinical Knowledge Summaries 4. Committee on Safety of Medicines. Current Problems. January 1988 No NHS Information Centre. Use of NICE appraised medicines in the NHS in England experimental statistics. September Glass J, Lanctot KL, Herrmann et al. sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ 2005; 331: Buscemi N et al. The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-analysis of RCTs. J Gen Intern Med 2007; 22: National Prescribing Centre. Prolonged-release melatonin (Circadin ). NPCi Rapid Review blog Circadin. Summary of Product Characteristics. Summary Identify and address any underlying cause of insomnia or associated comorbidities Offer advice on good sleep hygiene and stimulus control Hypnotics should be prescribed for short periods of time in strict accordance with their licensed indications, when insomnia is severe and interfering with normal daily life Prescribing and Spending on Hypnotic Drugs in England for Quarter to December 2010 ITEMS NIC Temazepam 693,614 2,242,354 Nitrazepam 323, ,732 Lormetazepam 14, ,526 Zopiclone 1,809,429 1,347,440 Zolpidem 185, ,686 Melatonin 45,854 3,532,048

7 Quarter to December 2010 National ITEMS/1000 PUs NIC/1000 PUs Temazepam Zopiclone Nitrazepam Melatonin

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