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Document name: Hypnotics in Clinical Version 5 Portfolio Document type: Medicines Management Policy Staff group to whom it applies: All clinical staff Distribution: The whole Trust How to access: Intranet Issue date: May 2013 Next review: May 2016 Approved by: Drug and Therapeutics Sub Committee Developed by: On behalf of the Drug and Therapeutics Sub Committee Director leads: Medical Director Contact for advice: [email protected] Tel 01924 327619 South West Yorkshire Partnership NHS Foundation Trust Abbreviations used in this document: BNF CCG CD CSM DVLA GI GP NICE NSF PCT SMRC SPC SWYPFT British National Formulary Clinical Commissioning Group Controlled Drug Committee on Safety of Medicines (Commission on Human Medicines) Drivers Vehicle Licensing Agency Gastro-Intestinal General Practitioner National Institute for Health and Clinical Excellence National Service Framework Primary Care Trust Scottish Medicines Resource Centre Summary of Product Characteristics South West Yorkshire Partnership NHS Foundation Trust Contents HYPNOTICS IN CLINICAL PRACTICE SUMMARY SHEET June 2010. 1 INTRODUCTION 3 2 BACKGROUND INFORMATION 2.1 Sleep disturbance ................................................................................. 2.2 Sleep hygiene measures ........................................................................ 2.3 About sleep ........................................................................................... 3 3 4 4 3 HYPNOTICS ............................................................................................... 3.1 Choice of hypnotics .............................................................................. 3.2 Benzodiazepines as hypnotics .............................................................. 3.3 Z-Drugs................................................................................................. 3.4 Antihistamines ...................................................................................... 3.5 Melatonin............................................................................................... 3.6 Others ……………………………………………………………….. 3.7 Table showing information on licensed hypnotics …………………. 5 5 6 7 7 8 8 9 4 PATIENTS ON LONG TERM TREATMENT 10 REFERENCES 11 APPENDICES Appendix 1: Sleep Diary Appendix 2: Withdrawal from Benzodiazepines 13 14 i South West Yorkshire Partnership NHS Foundation Trust HYPNOTICS IN CLINICAL PRACTICE SUMMARY SHEET Version 4 August 2012 PRIOR TO PRESCRIBING HYPNOTICS ALWAYS CONSIDER OTHER NON-PHARMACOLOGICAL STRATEGIES. ALL HYPNOTICS LEAD TO DEPENDENCE. IT IS MORE IMPORTANT TO FOCUS ON A PLAN FOR USING ANY HYPNOTIC FOR THE SHORTEST TIME POSSIBLE AND NOT JUST WHICH ONE APPEARS CHEAPEST. Hypnotics should only be used for the short-term treatment of intractable insomnia. Long-term chronic use is not recommended. Use should be short-term and preferably intermittent (BNF). For in-patients use the short courses or as required section on the prescription chart. Patients and their carers should be made aware at the beginning of treatment that the therapeutic effects of hypnotics are likely to be short lived. Hypnotics newly prescribed for in-patients should be discontinued prior to discharge. (Pharmacy will query all prescriptions for hypnotics on discharge unless the patient is identified as a “long term user” unwilling at present to reduce or stop). Hypnotics will be labelled “Caution – Long term use may lead to dependence” Choice of hypnotic in SWYPFT o Zopiclone 3.75 to 7.5mg at night o Zolpidem 5 to 10mg at night o Lorazepam 500 micrograms to 1mg at night for insomnia associated with anxiety on mental health inpatient units. o o o o Oxazepam 10 to 25mg at night for insomnia associated with anxiety Promethazine 25 to 50mg at night where other hypnotics are not suitable. Temazepam 10 to 20mg - restricted to existing users Nitrazepam 5 to 10mg - restricted to existing users and those addicts undergoing withdrawal from opiates For in-patients it can be useful to use lorazepam as a short term hypnotic particularly in highly aroused patients. It is the responsibility of the prescribing team to ensure hypnotics are regularly reviewed. If a duty doctor is called out to prescribe a hypnotic it should be prescribed in the once only section on the prescription chart. All advice and review dates should be clearly documented. NICE says use a hypnotic with a short half-life with the lowest cost per dose o Temazepam does have a low acquisition cost but as it is administered as a CD for in-patients this increases the actual cost to the trust. It is not recommended due to its previous history as a drug of abuse. o Lormetazepam and loprazolam were previously recommended for use but the cost per dose has now increased and not recommended for use in primary care. There has been continuing confusion with lorazepam. o NICE recommends that switching should only occur if there are documented adverse effects from a particular agent. Patients on long term treatment with all hypnotics o Continuation of the prescription needs to be met. o Only zopiclone will be a stock item on the in-patient wards. Temazepam, nitrazepam, lormetazepam, loprazolam and zolpidem will be available for individual patients who are long-term users. They will have to be requested for individual patients. o Consideration needs to be made to slow withdrawal when the time is appropriate for the client. This summary is taken from the SWYPFT document Hypnotics in clinical practice: Guidance on the use of hypnotics for the management of insomnia (in line with NICE Guidance No 77 2004) Guidance on the use of hypnotics for the management of insomnia 2 South West Yorkshire Partnership NHS Foundation Trust 1. INTRODUCTION This guidance has been produced to assist compliance with the 2004 NICE TA077 Guidance on the use of Zapelon, Zolpidem and Zopiclone in the short-term management of insomnia. It produces guidance for both the NHS and patients on medicines, medical equipment, diagnostic tests and clinical and surgical procedures and where they should be used. It has been updated following changes to costs of individual hypnotics. National guidelines recommend that benzodiazepines should be used to treat insomnia only when it is severe, disabling or subjecting the individual to severe distress (CSM, 1988; MeReC, 1995; Therapeutics Initiative, 1995). Long-term chronic use is not recommended. Use of benzodiazepines should be short-term and preferably intermittent (current BNF). NICE recommends the use of the hypnotic with the lowest acquisition cost. Prescribing of these drugs is widespread but dependence, both physical and psychological, and tolerance occurs. This may lead to difficulty in withdrawing the drug after the patient has been taking it regularly for more than a few weeks. Patients and their carers should be made aware at the beginning of treatment that the therapeutic effects are likely to be short lived and the future plan for reduction discussed. 2. BACKGROUND INFORMATION 2.1 Sleep disturbance Estimates of the prevalence of insomnia can vary widely, depending on its definition and on the population studied. Rates of 10 to 20 per cent are usual but rates of over 30 per cent have been reported (Mellinger et al 1985; Ohayon et al 1997). Causes of sleep disturbance can vary widely. The first step towards improving the sleep pattern is to establish and treat the primary cause. Insomnia should be considered as a symptom not a disease. Primary insomnia is rare, an underlying remediable cause can usually be found for sleep disturbance. Any factor, which increases activity in arousal systems or disrupts activity in sleep systems, may cause disturbance of sleep. A way of identifying these can be through the system of 5P’s - physical, physiological, psychological, psychiatric and pharmacological as identified by Lader (1992). Physical Acute or chronic pain, cardiovascular disease, endocrine disturbances, respiratory disease, tinnitus, Parkinson’s disease, myalgic encephalitis, myoclonus, restless legs, cramps, sleep apnoea syndrome, nocturia, pregnancy. Physiological External stimulation (snoring partner, strange bed), disruption of circadian rhythm (jet lag, shift work), late night exercise or heavy meals, increasing age. Psychological Emotional factors (stress, tension, grief, anger), abnormal concern about sleeping. Psychiatric Affective disorder (depression, hypomania, mania), psychosis, dementia, anxiety disorder. Pharmacological Guidance on the use of hypnotics for the management of insomnia 3 South West Yorkshire Partnership NHS Foundation Trust CNS stimulants (including caffeine, nicotine, “Ecstasy”), withdrawal of CNS depressants (including opiates, alcohol and benzodiazepines), cimetidine, clonidine, beta-blockers, corticosteroids. 2.2 Sleep hygiene measures For many patients who complain of insomnia, sleep can be improved by sleep hygiene measures (Ashton, 1997). In reality these are founded on common sense. Explanations about the variations in sleep requirements, particularly the decreased need for sleep with advancing age, may be helpful. The length of total sleep varies greatly between normal subjects with an average of 7 to 8 hours in adults, although some manage on much less. Some patients have unrealistic expectations to length of sleep required. The length of total sleep is reduced in the elderly to around 6 hours in the over 70s and increased daytime napping reduces night time sleep still further. It is useful to consider the following recommendations: Restrict caffeine intake in the evening (sensitivity to caffeine increases with age). Only have small amounts of alcohol (although it is a depressant, excess alcohol interferes with sleep). Reduce smoking particularly before bedtime, as nicotine is a stimulant. Avoid late night meals. Have light exercise daily but avoid vigorous late night exercise. Establish a pattern of going to bed and getting up at the same time daily avoiding daytime naps. (SMRC1995) The primary cause of the sleep disturbance should be treated together with the introduction of sleep hygiene measures. Patients and carers need to be given information on sleep and sleep disturbance including a copy of the good sleep guide and if appropriate a sleep diary (see Appendix 1). Useful written information is available from the SMRC 1995. Emphasis should be placed on the reduced need for sleep with advancing age, the importance of a regular pattern of going to bed and rising and the necessity to avoid daytime naps. 2.3 About sleep A sleep cycle consists of 5 stages that can be divided into two physiological states. These are known as quiet non rapid eye movement (non REM) sleep and paradoxical rapid eye movement (REM) sleep. The quiet sleep is divided into four stages. There is progressive relaxation of the muscles as well as slower and more regular breathing as the sleep moves from stage 1, light sleep, to stage 2, the first stage of deep sleep. This progresses to stages 3 and 4 of deep sleep (also known as slow wave sleep). Then during REM sleep there is a complete loss of muscle tone and frequent rapid eye movements with dreaming reported to take place in this phase of sleep (Wilson and Nutt, 2000). During normal sleep there are about 4-6 sleep cycles each of around 90100 minutes’ duration, ending in REM sleep. The amount of time spent in each stage of sleep varies. REM sleep is typically short with each stage normally lasting between 5 and 10 minutes with duration increasing as the night progresses, with the result that the majority of REM sleep occurs in the last third of the night (Shneerson, 2000). Guidance on the use of hypnotics for the management of insomnia 4 South West Yorkshire Partnership NHS Foundation Trust 3. HYPNOTICS Before a hypnotic is prescribed the cause of the insomnia should be established and, where possible, underlying factors should be treated. Management of insomnia requires resolution of any stressful precipitants or identification and treatment of any underlying causes, with an emphasis on non-pharmacological measures such as counselling, behavioural therapy, development of relaxation techniques, and avoidance of stimulant substances. If a hypnotic is indicated for transient insomnia, one that is rapidly eliminated should be chosen, and only 1 - 2 doses should be prescribed. For short-term insomnia a hypnotic can be useful but should not be given for more than 2 weeks (preferably only 1 week). They should be given in the lowest dose that controls symptoms. Intermittent use is desirable with omission of some doses. A rapidly eliminated drug is generally appropriate. They should be withdrawn by gradual tapering of the dose to zero. The NICE guidance recommends: Hypnotics should only be prescribed for short periods of time in strict accordance with their licensed indications Chronic insomnia is rarely benefited by hypnotics and is more often due to mild dependence caused by injudicious prescribing. This may lead to difficulty in withdrawing the drug after the patient has been taking it regularly for a few weeks. A major drawback of long-term use is that withdrawal causes rebound insomnia and precipitates a withdrawal syndrome. Hypnotics should not be prescribed indiscriminately and routine prescribing is undesirable. Hypnotics and anxiolytics should therefore be reserved for short courses to alleviate acute conditions after causal factors have been established. Tolerance to their effects develops within 3-14 days of continuous use and long-term efficacy cannot be assured. Where prolonged administration is unavoidable hypnotics should be discontinued as soon as feasible and the patient warned that sleep may be disturbed for a few days due to rebound effects before normal rhythm is re-established. 3.1 Choice of hypnotic All available hypnotics can produce tolerance and carry the risk of withdrawal effects (including rebound insomnia) if used regularly for more than a few weeks. See Appendix 2 - guidance for withdrawing benzodiazepines. If a hypnotic is to be used one with a short half-life is preferred to reduce the risk of daytime sedation. Information on the half lives and relative effects of and costs of the hypnotics are shown on page 6. Guidance on the use of hypnotics for the management of insomnia 5 South West Yorkshire Partnership NHS Foundation Trust SHORT TERM (Preferably intermittent) use only Zopiclone Zolpidem Lorazepam 3.75 - 7.5mg at bedtime Start at 3.75mg for elderly 5 to 10mg at night at bedtime Start at 5mg for the elderly and debilitated 500micrograms elderly 1mg to 2mg adult –start at lowest dose Suitable for use on inpatient mental health units Oxazepam 10 to 25mg at night for insomnia associated with anxiety Start at 10mg for elderly Promethazine 25 – 50mg only use if hangover effect is unlikely to be a problem Temazepam 10 – 20mg at night restricted to existing users Nitrazepam 5 – 10mg at night restricted to existing users and those undergoing withdrawal from opiates. 3.2 Benzodiazepine as hypnotics The benzodiazepines alter the normal sleep pattern by reducing the amount of slow wave and REM sleep, but they increase the amount of sleep time overall with a prolonged amount of light sleep. The effects of the benzodiazepines are mediated through GABA by binding to a specific site, the benzodiazepine receptor, located on the GABA-A/chloride receptor complex. They act by increasing the affinity of the GABA site making it easier for GABA to open the chloride channel. As a result the channel opens more quickly. The benzodiazepines contain a benzene ring linked to a seven-member diazepine ring. They are rapidly absorbed from the gastro-intestinal tract, although this absorption is slowed by food and particularly by antacids. A clinical effect is usually apparent within one hour and peak plasma levels usually occur between one and three hours after ingestion. Diazepam is a slowly eliminated benzodiazepine with a long half life licensed for short- term use in anxiety and insomnia related to anxiety. It is given in a dose of 5 to 15mg at bedtime. It should not be regularly used as a hypnotic due its long half life causing daytime sedation. There is a three fold increase in car driver accidents for patients taking longer acting benzodiazepines (CSM 1998). Lorazepam is short-acting benzodiazepine licensed for short-term use in anxiety and insomnia related to anxiety. It is normally given in a dose of 1 to 2mg at bedtime. The starting dose can be 500 micrograms for the elderly. It should be considered particularly for in-patients where there may be high state of arousal. It has a risk of dependence and its major use in psychiatry is in the rapid tranquillisation policy and as adjunct in the treatment of mania. Loprazolam and lormetazepam were previously recommended for use in line with NICE as low cost short acting benzodiazepine hypnotics. However the cost has now become prohibitive. These are no longer in the formulary. Guidance on the use of hypnotics for the management of insomnia 6 South West Yorkshire Partnership NHS Foundation Trust Nitrazepam is a slowly eliminated benzodiazepine with a long half-life (18 to 36 hours extended to 40 in the elderly). There is a potential for cumulative effects and daytime sedation making it particularly inappropriate for elderly patients. The summary of product characteristics (SPC) for nitrazepam recommends 5mg before retiring as the maximum daily dose in the elderly for a duration of not more than four weeks. When withdrawing it may be appropriate to consider gradual reduction of nitrazepam as, due to its long half life, there may be little benefit in switching to diazepam. Oxazepam is a short-acting benzodiazepine licensed for short-term use in anxiety and insomnia related to anxiety. It has a low acquisition cost, it is given in a dose of 10 25mg at bedtime. This is a reasonable choice of hypnotic for patients with associated anxiety. Temazepam has a short half-life. The availability is reducing and the cost has risen. It is prescribed in doses of 10 to 20mg at bedtime. It is no longer thought to be a suitable hypnotic as it widely used nationally as a drug of abuse (DTB, 1997). It is NOT recommended for new users in SWYPFT due to its potential for abuse. 3.3 Z-Drugs Initially it was thought that these newer hypnotics would be unlikely to cause dependence but there are increasing case reports of escalating doses, dependence and withdrawal problems in vulnerable patients (Sullivan et al, 1995; Clee et al, 1996; and Ravinshankar et al, 1998). Zopiclone is a cyclopyrroline with a half-life of around 5 hours that causes a low incidence of daytime drowsiness. It is less likely than the benzodiazepines to disturb the sleep pattern. The recommended dose range is 3.75 to 7.5mg. It mediates its effects through the GABA-A receptor complex but at a different site to the benzodiazepines (Noble et al 1998). When it was first launched, the recommended dose range was higher with the maximum dose being 15mg. The product licence was later altered. There is no specific guidance for withdrawal of long term users. Recent experience shows that from a 7.5mg dose reduce to 3.75mg for one to two weeks then trying intermittent doses of 3.75mg for the next one to two weeks can be tried. (An alternative strategy is also available in the appendices based on local practice in North Kirklees). It is not recommended to switch to a benzodiazepine hypnotic (NICE TA077). It is available as ward stock in SWYPFT. Zolpidem is an imidazopyridine with a half-life of around 2 hours that causes a low incidence of daytime drowsiness. It is rapidly absorbed giving an effect within thirty minutes that lasts up to 6 hours. The recommended dose range is 5 to 10mg. It is a selective agonist at the benzodiazepine type 1 receptor on the GABA-A receptor complex (Langtry and Benfield, 1990). Zaleplon is a pyrazolopyrimidine hypnotic with a short elimination half-life of about one hour. It significantly reduces the time taken to fall asleep in patients who experience difficulty in getting off to sleep. It is a selective agonist at the benzodiazepine type 1 receptor on the GABA-A receptor complex (Dooley and Plosker, 2000). This is not included in the formulary. Guidance on the use of hypnotics for the management of insomnia 7 South West Yorkshire Partnership NHS Foundation Trust 3.4 Antihistamines Antihistamines are available over the counter for the short-term treatment of insomnia. So far they are not thought to be as efficacious as benzodiazepines. In addition, they normally have long half-lives resulting in daytime drowsiness. Promethazine is available in the Trust as an alternative hypnotic for patients in whom other hypnotics are not recommended. It has a long half-life and there is the potential for hang over effect. Dose 25mg to 50mg at night. 3.5 Melatonin Melatonin is an agonist at M1, M2 and M3 receptors. (Bazire S) Circadin® is the only melatonin product licensed in the UK as a monotherapy course up to 13 weeks for primary insomnia in people aged 55 and over. The modified release tablets contain a synthetic melatonin, which is released over several hours to match the normal human melatonin profile. Dose 2mg one to two hours before bedtime. Children and adolescents The treatment of choice for sleep disturbance in children is behavioural; melatonin should only be prescribed after a full trial of behavioural management has been tried and failed to achieve satisfactory results. Prescribers should confirm this has been conducted. A shared care guideline is available in Calderdale, Wakefield and Kirklees. Melatonin is not licensed for use in children. However, Melatonin and melatonin modified release are used to improve the onset and duration of sleep in infants, children and adolescents with neurological and/or behavioural problems who have severe sleep disturbance. It can also be used to improve onset and duration of sleep in children and adolescents with congenital or acquired neurological/neurodevelopmental problems including conditions such as learning difficulties, Autism Spectrum Disorders, Cerebral Palsy, visual impairment, epilepsy and neurodegenerative disorders. It is also known that some psychiatric disorders can be associated with sleep problems eg ADHD or depression. Unlicensed immediate release preparations may be more suitable for children, especially where sleep initiation is the problem. The modified release preparation may be useful for sleep maintenance. A combination may be required where the child has difficulty falling asleep and maintaining sleep The manufacturer should be specified where immediate release products are used because of variability in clinical effect of unlicensed products (see shared care guideline for more information). Dose Child 1 month to 18 years initially 2-3 mg increased if necessary after 1-2 weeks to 4-6mg (max 10mg daily), see BNF for children and shared care guideline for more information. 3.6 Chloral derivatives (clomethiazole and cloral betaine) are restricted to existing users. Guidance on the use of hypnotics for the management of insomnia 8 South West Yorkshire Partnership NHS Foundation Trust 3.7 Table showing information on licensed hypnotics NB Always refer to the Summary of Product Characteristics for individual drugs Drug Usual dose Max dose Adult Elderly Short acting hypnotics (Formulary items in bold) 5 tablets Cloral betaine 1-2 tablets 707mg per tablet Clomethiazole 1 cap 2 caps 192mg Half life in hours Adult Elderly (range) (range) 4-5 Same 10 14 7-15 20 Same Lormetazepam 1mg 1.5mg Loprazolam 1mg 2mg 500 microgr ams 1mg Lorazepam 1mg 2mg 1mg 12 (8- 25) Melatonin CR (Circadin PR®) 2 mg 2mg 2mg Not applicable Oxazepam 15mg 50mg Not stated 8 (5-15) Same Temazepam 10-20mg 40 mg 20 mg 5-11 14 Zaleplon 10mg 10mg 5mg 2mg 3 Zolpidem 10mg 10mg 5mg Longer Zopiclone 3.75 -7.5mg 7.5mg 7.5mg 2 (2-5) 3.5-6 Long acting hypnotics Diazepam 5mg 15mg 7.5mg 32 (21-50) Longer Nitrazepam Promethazine 10mg 50mg 5mg 50mg 18-46 40 ? 5mg 25mg Refs vary from 5 to 19 hours Guidance on the use of hypnotics for the management of insomnia 8 Notes for use Cost per 28 days Low ≤ £20, Medium over £20 High over £50 Restricted to existing users. Medium Only for severe insomnia in the elderly Free from hangover effect High dependence potential No longer recommended due to cost Low No longer recommended due to cost High dependence potential Use for inpatients in particular those who are highly aroused. Risk of withdrawal symptoms Medium one to two hours before bedtime. Only licensed for people aged over 55 for thirteen weeks. Licensed for insomnia related to anxiety Medium High dependence potential Used as a drug of abuse Only available for existing users Not available in SWYPFT Very short half life therefore not suitable for patients with early morning wakening Some incidence of dependence emerging Dependence potential May cause unpleasant taste in the mouth Low Licensed for insomnia related to anxiety Hangover effect Can accumulate in the elderly Large hangover effect Prolonged duration of action Hangover effect Low Medium Low Low Low Low Low Low Low 9 South West Yorkshire Partnership NHS Foundation Trust 4 PATIENTS ON LONG-TERM TREATMENT Continuation prescriptions need to be written. However, the key is the regular review of patients on repeat prescriptions. A planned programme of reduction or withdrawal should be negotiated. However, for existing users it may not be appropriate to consider withdrawal during an exacerbation of the illness. Clinical judgement may suggest that continuing a course of benzodiazepines for longer than one month would be more beneficial for an individual than alternative treatments. The service user should be warned of the risks of tolerance and dependence, prescribing should be reviewed at regular intervals and periodic attempts to slowly reduce and stop should be made. Consideration needs to be made for slow withdrawal. See Appendix 2 for benzodiazepine withdrawal and for notes on a suggested programme for zopiclone. In Primary care the responsibility for prescribing and monitoring the use of hypnotics usually rests with the GP. The same principles as this policy may be applied regarding regular monitoring and encouragement of clients to reduce or stop their hypnotics (subject to any PCT/CCG guidance).. Guidance on the use of hypnotics for the management of insomnia 10 South West Yorkshire Partnership NHS Foundation Trust References Ashton H (1994) Guidelines for the rational use of benzodiazepines. When and what to use, Drugs 48(1): 25-40. Ashton HC (1997) Management of insomnia, Prescribers’ Journal 37: 1-10. Bazire S (2012) Psychotropic Drug Directory. British National Formulary, 63 (2012) London, UK: British Medical Association and Royal Pharmaceutical Society of Great Britain. Clee WB, McBride AJ, Sullivan G (1996) Warning about zopiclone abuse, Addiction 91: 1389-90. Committee on Safety of Medicines (CSM) (1988) Current problems Benzodiazepines, dependence and withdrawal symptoms, 21. Department of Health. The National Service Framework for Mental Health, (September 1999). Drug and Therapeutics Bulletin (DTB) (1997) CNS depressant drugs, 35. Dooley M, Plosker GL (2000) Zaleplon. A review of its use in the treatment of insomnia, Drugs 60(2): 413-445. Jones D (1990/91) Weaning elderly patients off psychotropic drugs in general practice: a randomised controlled trial, Health Trends 22(4): 164-66. Lader M ed. (1992) The medical management of insomnia in general practice, London: Royal Society of Medicine Services (Round table series 28). Langtry HD, Benfield P (1990) Zolpidem. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential, Drugs 40 (2): 291-313. Medicines Resource Centre (1995) Zopiclone and zolpidem, MeReC Bulletin 6: 4143. Mellinger GD, Balter MB, Uhlenhuth EH (1985) Insomnia and its treatment. Prevalence and correlates, Archives of General Psychiatry, 42: 225-50. Noble S, Langtry HD Lamb HM. (1998) Zopiclone. An update of its pharmacology, clinical efficacy and tolerability in the treatment of insomnia, Drugs 55(2): 277-302. NICE TA077 (2004) Guidance on the use of Zapelon, Zolpidem and Zopiclone in the short-term management of insomnia. Guidance on the use of hypnotics for the management of insomnia 11 South West Yorkshire Partnership NHS Foundation Trust Ohayon MM, Caulet M, Priest RG et al (1997) DSM-1V and ICD-10 insomnia symptoms and sleep dissatisfaction, Br J Psychiatry 171: 382-88. Ravinshankar A, Carnwath T (1998) Zolpidem tolerance and dependence-two case reports, J Psychopharmac 12(1): 103-104. Scottish Medicines Resource Centre SMRC (1995) Management of anxiety and insomnia, Medicines Resource 22: 83-86. Shneerson JM (2000) Handbook of Sleep Medicine (Oxford: Blackwell Scientific Publications). Sullivan G, McBride AJ, Clee WB (1995) Zopiclone abuse in South Wales; three case reports, Hum Psychopharmac 10: 351-52. Therapeutics Initiative (1995) To sleep or not to sleep, Therapeutics Initiative 11. Wilson S, Nutt DM (2000) Treatment options for patients with insomnia. Prescriber 5: 85-89 Benzodiazepines: risks and benefits. A reconsideration. Report from a Working Group of the Royal College of Psychiatrists(Psychopharmacology Special Interest Group) and the British Association for Psychopharmacology. October 2012 Guidance on the use of hypnotics for the management of insomnia 12 South West Yorkshire Partnership NHS Foundation Trust Appendix 1 SLEEP DIARY It will help us to find the best way to deal with your sleep problem if you can keep a sleep diary for a short time. All you have to do is fill in the diary below as soon as possible after getting up; it only takes a few minutes. Recording the pattern and quality of your sleep can help you find out what is keeping you up at night. When you come back to see me, we can decide together the best way to deal with the problem. Date Describe all activities for the Three Hours Before Bed including any food & drink you had. How many sleeping tablets did you take to help you sleep? Time You Went to Bed How long did it take you to fall asleep (mins)? Time you woke up the next morning How many times did you wake up What Woke You Up During the Night Total hours slept How well did you feel in the Morning and how enjoyable was your sleep? Y:\From F\MEDICINE MANAGEMENT\GUIDELINES\CURRENT\Hypnotic Prescribing Guidelines March 2007 (final).doc Guidance on the use of hypnotics for the management of insomnia 13 South West Yorkshire Partnership NHS Foundation Trust Appendix 2 Withdrawal from Benzodiazepines If it is considered appropriate to withdraw a chronic user from a benzodiazepine then it should be tapered off and withdrawn slowly. Reasons for non-withdrawal should be recorded in the notes. Specialist advice may be appropriate for some patients (e.g. patients with psychosis or severe anxiety). Time required for withdrawal will depend on the patient and can take from 4 weeks to a year or more (although two weeks may be enough after a short course of benzodiazepines). When planning to implement a withdrawal programme, the motivation of the patient is paramount. The withdrawal programme should be tailored to the individual’s response and needs. The dose should be reduced in steps of about one-eighth of the original daily dose every two weeks by a similar amount (range one-tenth - one-quarter), i.e. if a patient starts on 40 mg of diazepam, reduce by 5 mg a fortnight. If necessary change the benzodiazepine to an equivalent dose of diazepam given at night and then reduce the dose of diazepam in increments as described above. Diazepam has a relatively long half-life and appears to be associated with less ‘craving’; however there may be a problem with daytime sedation. (In reduction of Zopiclone it is suggested that it be prescribed initially as 3.757.5mg at night for up to 2 weeks. Thereafter it should be reduced to 1.8753.75mg at night for a week and 1.875mg at night in the 4th week and it should then be stopped). NOTE Withdrawal symptoms can occur with benzodiazepines following therapeutic doses given for short periods of time. Benzodiazepines should not be discontinued abruptly after regular use for even a few weeks, but should be withdrawn by gradual reduction of the dose. All hypnotic prescriptions should be reviewed weekly. Withdrawal effects usually appear shortly after stopping a benzodiazepine with a short half-life, but may not develop for up to 3 weeks after stopping one with a long halflife. Symptoms may continue for weeks or months. These may be difficult to distinguish from the symptoms of the original illness; refer to table 1 on withdrawal symptoms. Development of dependence cannot be predicted but risk factors include: High dosage Regular continuous use Use of benzodiazepines with a short half-life Use in patients with dependent personality characteristics History of drug or alcohol dependence Development of tolerance Guidance on the use of hypnotics for the management of insomnia 14 South West Yorkshire Partnership NHS Foundation Trust Withdrawal symptoms Table 1 Anxiety type Disturbance of Perception Severe but rare Anxiety Hypersensitivity Paranoid psychosis Dysphoria Abnormal bodily sensations Depressive illness Tremor Abnormal sense of movement/sway Seizures Muscle pains Depersonalisation Sleep disturbance Visual disturbance Headache Nausea, Anorexia Sweating, Fatigue EQUIVALENT DOSES OF BENZODIAZEPINES Benzodiazepine Equiv. Dose Duration of action Diazepam 5 mg 2 – 4 days Lorazepam 500 mcg 8 – 12 hours Chlordiazepoxide 15 mg 2 – 4 days Nitrazepam 5 mg 12 – 24 hours Oxazepam 15 mg 8 – 12 hours Temazepam 10 mg 8 hours Clonazepam 500 mcg 1 – 2 days Guidance on the use of hypnotics for the management of insomnia 15