GUIDELINES FOR THE MANAGEMENT OF INSOMNIA MAY This policy supersedes all previous policies relating to Insomnia

Transcription

1 GUIDELINES FOR THE MANAGEMENT OF INSOMNIA MAY 2017 This policy supersedes all previous policies relating to Insomnia

2 Policy title GUIDELINES FOR THE MANAGEMENT OF INSOMNIA Policy PHA08 reference Policy category CLINICAL Relevant to All CLINICAL STAFF IN THE TRUST Date published May 2017 Implementation May 2017 date Date last February 2017 reviewed Next review March 2019 date Policy lead LUCY REEVES, Chief Pharmacist Contact details Accountable director Approved by Approved by (Committee): Document history Membership of the policy development/ review team Consultation Telephone: DR VINCENT KIRCHNER, ACTING MEDICAL DIRECTOR Drugs and Therapeutics Committee February 2017 Quality committee 16 May 2017 Date Version Summary of amendments Feb Feb Melatonin restricted for sleep disorders in patients with learning disabilities. Use of hyptics in medical conditions, tapering schedules, driving offence Mar What is t recommended Mar Zopiclone has been included as a first line hyptic Mar Review Dec New Guidelines AUDREY COKER, LEAD PHJARMACIST FOR CLINICAL SERVICES. Dr Lucinda Donaldson, Consultant for Perinatal Services, Dr Gina Waters Consultant for Perinatal Services. DO NOT AMEND THIS DOCUMENT Further copies of this document can be found on the Foundation Trust intranet. Guidelines for the management of insomnia_pha08_may 2017 i

3 Contents Page 1 Introduction 1 2 Aims and objectives 2 3 Scope of the policy 2 4 Key points 2 5 Assessment of insomnia 3 6 Promote sleep hygiene principles 5 7 Treatment of insomnia 6 8 Monitoring 9 9 Melatonin Dissemination and implementation arrangements Training requirements Monitoring and audit arrangements Review of the policy References 11 Appendix 1: Algorithm for the assessment and management of transient /short term insomnia. Appendix 2: Medicines for which management of insomnia would be a n-formulary indication as a main indication Appendix 3 How to manage withdrawal of long-term benzodiazepine and z-hyptic use Appendix 4: Equality impact assessment tool Guidelines for the management of insomnia_pha08_may 2017 ii

4 1 INTRODUCTION Insomnia is a condition of unsatisfactory sleep, either in terms of sleep onset, sleep maintenance or early waking. Insomnia impairs daytime well-being and subjective abilities and functioning, and so can be considered a 24-hour disorder. It is important to recognize that insomnia is a subjective disorder, and its diagsis is through clinical observations rather than via measurements. However, in some cases it may be possible to identify and remedy a physical cause for insomnia. Insomnia often starts with a specific problem, for example a stressful life event such as the loss of a job or change to a more demanding one, or through something that changes sleep patterns such as the birth of a child or starting shift work. In some people this acute insomnia persists into a chronic state. Factors involved in the persistence of insomnia are t fully established, but include anxiety about sleep, maladaptive sleep habits and the possibility of an underlying vulnerability in sleep-regulating mechanisms. Persistence of the precipitating stressor can also contribute. Some cases of insomnia are precipitated by, or are co-morbid with, other psychiatric disorders, especially anxiety and depression, or by physical illness such as cancer or arthritis. The nature of sleep changes with age. Older age is associated with poorer objectively measured sleep with shorter sleep time, diminished sleep efficiency, and more arousals, and these changes may be more marked in men than in women Insomnia can be classified according to cause: Transient insomnia may occur in those who rmally sleep well and may be due to an alteration in the conditions that surround sleeping e.g. ise, or to an unusual pattern of rest e.g. shift work or travelling between time zones (jet lag) 2. It may also be associated with acute disorders. It may only be short term, lasting between 1-4 weeks. Primary insomnia is insomnia that occurs when co-morbidity is identified. Commonly the person has conditioned or learned sleep difficulties with or without heightened arousal in bed. Typically primary insomnia has a duration of at least one month 3. Comorbid (or secondary) insomnia is when insomnia occurs as a symptom of or is associated with other conditions including medical or psychiatric illness or drug or substance misuse Insomnia can also be categorised according to duration or likely duration. Whilst definitions can vary, insomnia is categorised as: Short-term if insomnia lasts between one to four weeks 3. Long-term (or persistent) if insomnia lasts for four weeks or longer 3. Part of a state of high arousal secondary to severe psychiatric disturbance The underlying cause of insomnia also needs to be identified and corrected whenever possible. Relatively short-term insomnia may be helped by a very limited course of a benzodiazepine or other hyptic medicine, but is more usually managed without hyptics. Long-term use of hyptic medication is t justified and may be hazardous or itself be the cause of sleep problems. In chronic insomnia, physical or psychiatric causes should be considered especially in the elderly. Guidelines for the management of insomnia_pha08_may

5 2 AIMS AND OBJECTIVES To provide clear guidance on the appropriate and safe use of medication to control insomnia. 3 SCOPE OF THE GUIDELINE The guideline covers both the benzodiazepine hyptics and z-hyptics. It is aimed at all clinical staff working in Camden and Islington NHS Foundation Trust This guideline relates to pharmacological management of insomnia. The guideline is only concerned with prescribing benzodiazepines for the treatment of insomnia. Their role in anxiety management is NOT within the scope of this document. 4 KEY POINTS Table 1: Medicine choice in the management of insomnia Options Medicine choice Comments First line Zopiclone 3.75mg tablets, 7.5mg tablets. Sch 4 CD Second line Temazepam 10mg, 20mg tablets, liquid 10mg in 5ml. Sch 3 CD. Third line Zolpidem 5mg tablets, 10mg tablets Pregnant women Promethazine NICE CG 192. Off-label Inpatients should t routinely be written up for hyptics. This is rarely necessary and may establish a need to continue afterwards With increased awareness of the problems of benzodiazepine dependence, proper use and careful patient selection is essential. See Appendix 1 for How to manage withdrawal of long-term benzodiazepine and z-hyptic use. CSM ADVICE 2 1. Benzodiazepines are indicated for the short-term relief (two to four weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. 2. The use of benzodiazepines to treat short term mild anxiety is inappropriate and unsuitable. 3. Benzodiazepines should be used to treat insomnia but only when it is severe, disabling or subjecting the individual to extreme stress. CSM ADVICE Guidelines for the management of insomnia_pha08_may

6 Table 2: Hyptic relative effects Drug Cost Dose range (mg) Elimination half-life (hours) Adult Elderly Adult Elderly Zopiclone (sch. 4 CD) Zolpidem (2-3) longer Temazepam (sch. 3 CD) Max Max ASSESSMENT OF INSOMNIA Algorithm for the assessment & management of transient/short term insomnia is shown in Appendix Before considering medication for the treatment of insomnia an assessment should be done to establish the severity and any underlying causes. Table 3: Assessment of insomnia Take a thorough sleep history. Determine the pattern of sleep. Duration of disturbance. Look for possible causes. Assess the person s beliefs about what they regard as rmal sleep and the impact of insomnia on the person s quality of life, ability to drive, employment, relationships and mood 3. Is the sleep pattern rmal? Onset of sleep is usually thirty minutes. Total sleep time decreases with increasing age 3. Is there difficulty sleeping, early morning wakening, day time sleepiness or a general loss of well-being through a perception of a bad night s sleep 4? Is there circadian rhythm disorder? Other factors e.g. jet lag, shift working. Assess duration of symptoms:- Short-term insomnia is diagsed if insomnia has been present for less than 4 weeks 3. Long-term insomnia is diagsed if insomnia has been present for longer than 4 weeks 3. See table 4 for other possible causes. If the underlying cause is t clear, consider asking the person to keep a sleep diary for two weeks. This should record the time of going to bed and getting up, time to get to sleep and number and duration of episodes of waking through the night, episodes of daytime tiredness and naps, times of meals, alcohol consumption, caffeine consumption and significant events. Rating of sleep quality from 1 to 5 (1 very poor and 5 very good. An example of a sleep diary can be located at the following link: 3 Guidelines for the management of insomnia_pha08_may

7 5.2 Causes of primary insomnia Primary insomnia has identifiable underlying condition causing it. It may occur as a result of a conditioned response in which the person associates the sleeping environment with heightened arousal. It often starts in response to a stressful event, but continues despite resolution of the event Causes of secondary insomnia Table 4: Possible causes of secondary insomnia 3 Other sleep Sleep apnea. disorders Disruption of circadian rhythms, e.g. from jet-lag or shift-work. Parasomnias e.g. restless legs syndrome, sleep walking, sleep talking, night terrors. Narcolepsy. Stress Situational stress e.g. occupational, interpersonal, financial, academic, medical and environmental stress. Medical Acute or chronic pain. Cardiovascular angina or congestive heart failure. Respiratory disease chronic obstructive pulmonary disease, asthma. Neurological Alzheimer s disease, Parkinson s disease. Endocrine thyroid dysfunction. Genito-urinary disorders. Gastrointestinal disorders. Rheumatological disorders. Physiological and External stimuli, e.g. a sring partner or a strange bed. Environmental Too much light or poor room temperature control. Late-night heavy meals or exercise. Psychological Emotional factors (stress, tension, grief, anger). Abrmal concern about sleeping; subjective insomnia Situational stress occupational, interpersonal, financial, academic, medical. Psychiatric Anxiety disorders. Bipolar disorder. Psychosis. Depression. Pharmacological Hormones e.g. corticosteroids, thyroid hormones. Antihypertensives e.g. betablockers, calcium channel blockers Some antidepressants serotonin reuptake inhibitors, venlafaxine, bupropion, duloxetine, moamine oxidase inhibitors). Antiepileptics - lamotrigine, phenytoin. Non-steroidal anti-inflammatory medicines. Stimulants e.g. methylphenidate and modafanil. Sympathomimetics - salbutamol, salmeterol, theophylline, pseudoephedrine. Substance Misuse Alcohol. Recreational drugs. Nicotine. Caffeine. Guidelines for the management of insomnia_pha08_may

8 6 PROMOTE SLEEP HYGIENE PRINCIPLES Sleep hygiene aims to make people more aware of behavioural, environmental and temporal factors that may be detrimental or beneficial to sleep. Advise the person to: Establish fixed times for going to bed and waking up (and avoid sleeping in after a poor night s sleep) 3. Try to relax before going to bed 3. Maintain a comfortable sleeping environment t too hot, cold, isy or bright 3. Avoid napping during the day 3. Avoid caffeine, nicotine and alcohol within six hours of going to bed 3. Consider complete elimination of caffeine from the diet 3. Avoid exercise before bedtime (although exercise earlier in the day is beneficial. Avoid eating a heavy meal late at night 3. Avoid watching or checking the clock throughout the night 3. Only use the bedroom for sleep or sexual activity 3. Have a copy of the sleep hygiene leaflet from the Choice and Medication leaflet CBT (Cognitive Behavioural Therapy) for insomnia can be provided by psychologists to patients being referred to them 6. 7 TREATMENT OF INSOMNIA 7.1 Initiation All patients should have an objective assessment of their sleep documented on sleep charts/diary. Consideration of the cause of the insomnia should be made Information and advice on sleep hygiene 3 should be the rm and may in many cases prevent the need to prescribe hyptics. Indiscriminate and routine use of hyptics is t recommended Hyptics should be reserved for short courses in the acutely distressed. Tolerance to their effects develops within 3-14 days of continuous use and long-term efficacy cant be assured. A major drawback of long-term use is that withdrawal can cause rebound insomnia and a withdrawal syndrome Ensure where possible any current sedative medicines are prescribed at night and medicines likely to disturb sleep are prescribed during the day Advise the person t to drive while taking the medicine until they kw how it affects them (especially just after starting or changing the dose). It is against the law to drive if your driving ability is impaired by this medicine Z-hyptics are recommended by NICE for the short-term management of severe insomnia that interferes with rmal daily life and should be prescribed for short periods 2. Zopiclone is 1 st line hyptic in the Trust, whilst temazepam is second Guidelines for the management of insomnia_pha08_may

9 line. Zolpidem is included as a third-line agent, however it is contraindicated in patients with a psychotic illness Use the lowest effective dose 4, Use intermittent dosing (alternate nights or less) where possible If prescribed on the as required side of the prescription chart hyptics should t be administered routinely to patients at a set time, but must be timed to the rmal time the patient retires to bed Prescribe for short-term use ( more than four weeks) in the majority of cases 4, Be alert for rebound insomnia/withdrawal symptoms Advise patients of the interaction with alcohol and other sedating medicines 4, Cautions For further information check the specification of product characteristics or contact the Pharmacy department for advice Avoid the use of hyptics in patients with respiratory disease or severe hepatic impairment and addiction-prone individuals Z-hyptics in hepatic impairment: Zopiclone can precipitate coma. Reduce the dose. Avoid in severe impairment 2. Zolpidem can precipitate coma. Reduce the dose to 5mg. Avoid in severe impairment Z-hyptics in renal impairment: Zopiclone start with small doses in severe impairment. Increased cerebral sensitivity. Zolpidem Use with caution Benzodiazepines in hepatic impairment: benzodiazepines can precipitate coma if used in hepatic impairment. If treatment is necessary, temazepam has a shorter halflife compared to some other benzodiazepines. Smaller doses should be initiated and avoid in severe impairment Benzodiazepines in renal impairment: patients with renal impairment have increased cerebral sensitivity to benzodiazepines. Smaller doses should be started in severe impairment 2. Guidelines for the management of insomnia_pha08_may

10 7.3 Pregnancy and Breastfeeding Non-medicine measures are preferred 4. For patients with serious and chronic problems, promethazine may be considered Z-hyptics in pregnancy: Zopiclone- avoid regular use (risk of neonatal withdrawal symptoms). High doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression 2. Zolpidem avoid especially in the first trimester 5. Avoid regular use (risk of neonatal withdrawal symptoms). High doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression Z-hyptics in breast-feeding: Zopiclone present in milk avoid 2. Zolpidem small amounts present in milk avoid Benzodiazepines in pregnancy: there is a risk of neonatal withdrawal symptoms when benzodiazepines are used in late 10 pregnancy and use should be avoided. High doses administered during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression 2. Temazepam should be avoided especially in the first and third trimester 11. Evidence for teratogenicity is unconfirmed. First trimester exposure to benzodiazepines has been associated with increased risk of oral clefts in newborns, although one study failed to confirm this association. Benzodiazepines have also been associated with pylorostesis and alimentary tract atresia, but a replication of these finds is required Benzodiazepines in breast-feeding: Benzodiazepines are present in milk and should be avoided if possible Short-term insomnia (<4 weeks) Consider a short course of a hyptic only if day time impairment is severe 2 on an as required basis Use the lowest effective dose for the shortest period possible. The exact duration would depend on the underlying cause, but treatment should t be continued for longer than two weeks Advise the person further prescriptions for hyptics will t usually be given, ensure the reasons for this is understood and document in the person s tes. Do t issue out further prescriptions without seeing the person again If there is response to the first hyptic, do t prescribe ather If the person experiences adverse effects considered to be directly related to the hyptic, consider switching to ather Review after two weeks and consider referral for cognitive behavioural therapy if symptoms persist 3. Guidelines for the management of insomnia_pha08_may

11 7.4.7 Diazepam is t generally recommended, but it can be useful if insomnia is associated with day time anxiety 2, Long-term insomnia (>4weeks) Advise on good sleep hygiene and regular exercise Refer to psychological services (Improving Access to Psychological Therapies) for cognitive or behavioural intervention Pharmacological management is generally t recommended for the long-term management of insomnia. However for people with severe symptoms or an acute exacerbation of persistent insomnia, a short course of a hyptic may be considered for immediate relief of symptoms 3 on an as required basis Use the lowest effective dose for the shortest period possible. The exact duration would depend on the underlying cause, but treatment should t be continued for longer than two weeks 3. Up to four weeks may occasionally be required, but continued use should always be re-assessed after two weeks Advise the person further prescriptions for hyptics will t usually be given, ensure the reasons for this is understood and document in the person s tes. Do t issue out a further prescriptions without seeing the person again Hyptics are t recommended for long-term use as there are concerns regarding their safety. Potential adverse events include day time sedation, poor coordination, cognitive impairment and related concerns about risk of driving accidents and falls. Long-term use of hyptics can lead to the development of tolerance, physical and behavioural dependence, adverse effects on withdrawal, rebound insomnia and increased mortality Use caution when prescribing hyptics for older people 3. 8 MONITORING As benzodiazepines and z-hyptics cause drowsiness and increase the effects of alcohol, patients should be advised t to drink alcohol 5. If a patient appears intoxicated (with alcohol), then administration of the hyptic should be withheld Hyptics may impair judgement and increase reaction time and so affect ability to drive and operate machinery. Moreover the hangover effect of a night dose may impair driving the following day A paradoxical increase in hostility, aggression, anxiety and perceptual disorders may be reported by patients taking benzodiazepines. Adjustment of the dose (up or down) sometimes attenuates the impulses Benzodiazepines and z-drug hyptics should be avoided in the elderly because the elderly are at greater risk of becoming ataxic and confused leading to falls and injury 7. The use of benzodiazepines and Z-hyptics is associated with an increased risk of falls and hip fractures in the elderly 12. If prescribed hyptics, this group of patients must be closely monitored on the ward. A falls assessment must be carried out: Guidelines for the management of insomnia_pha08_may

12 8.1.5 On discharge, night sedation should be stopped or continuing use justified in the tes. Information should be relayed to primary care/ secondary care colleagues if prescribing of hyptics is to continue. All changes should be discussed with the patient. If a patient is being discharged on a hyptic or prescribed a hyptic in outpatients, a care plan should be written to the GP in relation to stopping it Where prolonged administration is unavoidable, hyptics should be discontinued as soon as feasible and the patient warned that sleep may be disturbed for a few days before rmal rhythm is re-established; broken sleep with vivid dreams may persist for several weeks 4. See appendix 1 (How to manage withdrawal of long-term benzodiazepine / z-hyptic use). 9 Melatonin Melatonin is restricted in the formulary for sleep disorders in patients with learning disabilities (off label indication). Treatment should be in accordance with NICE guidance 17 as follows (9.1.2.to 9.1.4): Consider behavioural interventions for sleep problems in children, young people and adults with a learning disability and behaviour that challenges that consist of: a functional analysis of the problem sleep behaviour to inform the intervention (for example, t reinforcing n-sleep behaviours) structured bedtime routines Do t offer medication to aid sleep unless the sleep problem persists after a behavioural intervention, and then only: after consultation with a psychiatrist (or a specialist paediatrician for a child or young person) with expertise in its use in people with a learning disability together with n-pharmacological interventions and regular reviews (to evaluate continuing need and ensure that the benefits continue to outweigh the risks) If medication is needed to aid sleep, consider melatonin [2] Higher doses, up to a maximum of 12mg daily, may be required for this patients with learning disability Treatment should be reviewed regularly, at 3-6 monthly intervals. Guidelines for the management of insomnia_pha08_may

13 10 DISSEMINATION AND IMPLEMENTATION ARRANGEMENTS This document will be circulated to all managers who will be required to cascade the information to members of their teams and to confirm receipt of the procedure and destruction of previous procedures/policies which this supersedes. It will be available to all staff via the Foundation Trust intranet. Managers will ensure that all staff are briefed on its contents and on what it means for them. 11 TRAINING REQUIREMENTS For training requirements please refer to the Trust s Mandatory Training Policy and the Learning and Development Guide on the Trust intranet There is a junior doctors induction programme which signposts key prescribing procedures and medicines management policies. There is also access to the policy folder on the Trust intranet via the induction package. 12 MONITORING AND AUDIT ARRANGEMENTS Elements to be monitored Hospital patients are being prescribed hyptics in line with the policy. Lead Chief Pharmacist. How trust will monitor compliance All prescriptions for hyptics on inpatient charts are clinically screened by a Pharmacist Prior to dispensing. Freque ncy ongoing Reporting arrangements Which committee or group will the monitoring report go to? Drugs and Therapeutics Committee Acting on recommendat ions and Lead(s) Which committee or group will act on recommendati ons? Drugs and Therapeutics Committee Change in practice and lessons to be shared How will changes be implemented and lessons learnt/ shared? Review of policy; implementation practices and procedures Hyptic prescribing Chief Pharmacist Audit annual Drugs and Therapeutics Committee 13 REVIEW OF THE POLICY March 2019 Guidelines for the management of insomnia_pha08_may

14 14 REFERENCES 1. `Journal of Psychopharmacology 24(11) available at by S.J.Wilson 2. BNF September Clinical Kwledge Summary available online at: 4. Taylor D., Paton C., Kapur S. Editors. The South London and Maudsley NHS Foundation Trust. Oxleas NHS Foundation Trust. Prescribing Guidelines. 12 th Edition. London. Informa Healthcare Safi. The specification of product characteristics. Stilct. (4 th September 2014) (online). Available: (accessed 9th of December 2014). 6. from Jeff Halperin to Rashmika Shah. CBTi. 29 April Drug Safety update. Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence.(online). Available: (accessed 29th January 2015). 8. Chawla J. and Benbadis S.R. Insomnia treatment and management. (updated 25 th August 2014). (online). Available: treatment#aw2aab6b6b3 (accessed 9 th of December 2014). 9. National Institute for Health and Clinical Excellence. Antenatal and postnatal mental health. Clinical management and service guidance. NICE clinical guidance 192. Last updated June and-postnatal-mental-health-clinical-management-and-service-guidance (accessed 9th January 2017) from Dr Nisha Shah to Audrey Coker. Nisha Shah RE: Benzodiazepines and Z-hyptics. 5 th December Actavis. The specification of product characteristics. Temazepam. (30 th October 2014) (online). Available: accessed 9th of January 2017). 12. Bazire S. The Psychotropic Drug Directory. The professionals pocket handbook and aide memoire Baldwin D.S. et al. Evidence based guidelines for the pharmacological treatment of anxiety disorder. Recommendations from the British Association for Psychopharmacology. Journal of psychopharmacology, 19 (6) (2005), p Baldwin et al. Benzodiazepines: Risks and benefits. A reconsideration.2013, Journal of Psychopharmacology 27(11) Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive.Drug Misuse and Dependence. (online) Available: (accessed 9th of December 2014). 16. National Institute for Health and Clinical Excellence. Benzodiazepine and Z-drug withdrawal. (online) Available:: (accessed 9 th of December 2014). 17. National Institute for Health and Clinical Excellence. NICE Guidance (NG11) Challenging behaviour and learning disabilities: prevention and interventions for people with learning disabilities whose behaviour challenges. May 2015 Guidelines for the management of insomnia_pha08_may

15 APPENDIX 1 How to manage withdrawal of long-term benzodiazepine and z-hyptic use: Benzodiazepines Benzodiazepines are widely ackwledged to cause dependence and tolerance and withdrawal symptoms (see below) can occur after 4-6 weeks of continuous use 4. Shortacting ones such as lorazepam are associated with more problems on withdrawal than the longer-acting ones such as diazepam 4. To avoid or reduce the severity of these problems, good practice states that benzodiazepines should t be prescribed as hyptics or anxiolytics for longer than four weeks 4. Withdrawal symptoms from benzodiazepines 4 Physical: Stiffness Weakness Gastrointestinal disturbance Paraesthesia Flu-like symptoms Visual disturbances Psychological: Anxiety/Insomnia Nightmares Depersonalisation Decreased memory and concentration Delusions and hallucinations Depression Managing withdrawal Confirm usage by: Checking the prescription Urine screening if obtained illicitly (very short-acting benzodiazepines may t give a positive urine screen despite daily use) 4. A tolerance test is required if patient has been obtaining illicit supplies. No benzodiazepines or alcohol should be consumed for twelve hours before the test. A test dose of 10mg diazepam should be administered and patient observed for 2-3 hours (20mg if consumption of > 50mg daily is claimed or suspected). If there are signs of sedation, it is generally safe to prescribe the same dose as the test dose, three times daily. Some patients may require much higher doses. In these cases inpatient assessment would be better 4. Problematic withdrawal can be anticipated if 4 : Previous attempts have been unsuccessful Lack of social support History of alcohol/polydrug abuse Withdrawal seizures Elderly patients Severe psychiatric/physical disorders Personality disorder Guidelines for the management of insomnia_pha08_may

16 Withdrawal is too rapid All above must be taken into consideration and patient monitored closely during benzodiazepine withdrawal. Discontinuation symptoms have their peak severity at two days for short half-life and four to seven days for long-half-life benzodiazepines 13. All patients should be made aware of the risks of dependence if they continue benzodiazepines in regular dosage over a longer period. A clinical judgement has to be made as to whether alternatives may be more suitable, for each patient, and for each proposed medication 14. There is increasing evidence that long-term prescribing (especially of more than 30 mg diazepam equivalent per day) may cause harm. Clinicians may be faced with requests to continue a prescription for maintenance benzodiazepines. To prevent symptoms of benzodiazepine withdrawal, the clinician should continue the prescription but the dose should be gradually reduced to zero. Very rarely should doses of more than 30 mg diazepam equivalent per day be prescribed 15. Prescribing to assist withdrawal should only be initiated where there is clear evidence of benzodiazepine dependency from the patient s history, observed symptoms and drug testing. The aim should be to prescribe a reducing regimen for a limited period of time 15. The rate of withdrawal is often determined by an individual s capacity to tolerate symptoms. Benzodiazepines, including diazepam, can be withdrawn in proportions of about one-eighth (between one-tenth and one-quarter) of the daily dose every fortnight. In dependence on therapeutic doses, the dose can be reduced initially by mg and if withdrawal symptoms occur, then the dose can be maintained until symptoms improve. If the patient is t coping and is experiencing severe withdrawal symptoms, it may be necessary to increase the dose to alleviate the symptoms 15. If very high dose prescribing is required the patient should be referred for specialist assessment. Specialist practitioners then need to exercise caution in their assessments and prescribing. If the patient is stable and free of withdrawal symptoms, at for example 50 mg a day, the dose should be gradually reduced at a faster rate than suggested, for example by half over six weeks and then the planned rate of reduction should be again reviewed in line with the guidance outlined previously. This faster rate of reduction from very high doses led to convulsions even in a group who had a high incidence of these during previous benzodiazepine withdrawals 15. In the inpatient setting it is appropriate to provide a slow withdrawal regimen over one to four weeks, with diazepam starting at a daily dose of more than 30 mg, and usually less, given in divided doses 15. If the patient is in agreement, benzodiazepines should be withdrawn in line with the following considerations: Switching to diazepam patients should be offered the equivalent dose of diazepam as it has a long half-life. The approximately equivalent doses are in table 6 4. Table 6: Switching from benzodiazepine to diazepam: doses 4,14,15 Benzodiazepine Approximate dose (mg) equivalent to 10mg diazepam Nitrazepam 10mg Oxazepam 30mg Temazepam 20mg Zaleplon* 20mg Zopiclone 15mg Zolpidem 20mg *These are n-formulary medicines. Guidelines for the management of insomnia_pha08_may

17 Diazepam is available in a variety of strengths (2mg, 5mg and 10mg), scored tablets and liquid to facilitate switching 16. Diazepam substitution may t be appropriate for patients with hepatic dysfunction 13. Table 7 shows a suggested taper schedule; some patients may tolerate a more rapid reduction and others may require a slower taper 4. Table 7: Suggested schedule for reducing dosage of benzodiazepines 4 Reduce by 10mg/day every one to two weeks to a daily dose of 50mg Reduce by 5mg/day every one to two weeks to a daily dose of 30mg Reduce by 2mg/day every one to two weeks to a daily dose of 20mg Reduce by 1mg/day every one to two weeks until stopped. Usually more than one week s supply (exact number of tablets) should be issued at any one time. Gradual dose reduction accompanied by psychological intervention is more likely to be successful than dose reduction alone 4. How to manage withdrawal of long-term z-hyptic use 16 : Switching to diazepam:- This information is a guide. Exact substitution is t possible due to differences in potency between benzodiazepines and z-medicines differences in half-lives and response to individual medicines e.g. in terms of sedation. Consequently, a complete dose substitution may t always be required depending on individual response and to avoid excessive sedation. Switching to diazepam should be done gradually. Consider making the first switch in the night-time dose to avoid day time sedation. Dose withdrawal may be started when conversion to diazepam is complete. For dose equivalents, see table 6. Examples of switching schedules for the three commonest hyptics to diazepam are as follows:- Table 8: Switching schedules 16 Temazepam 10mg to In week 1 convert temazepam 10mg straight to diazepam 5mg. diazepam 5mg Temazepam 20mg to diazepam 10mg Nitrazepam 5mg to diazepam 5mg Nitrazepam 10mg to diazepam 10mg Zopiclone 7.5mg to diazepam 5mg Zopiclone 15mg to diazepam 5mg In week 1 convert temazepam 20mg to temazepam 10mg and diazepam 5mg. In week 2 convert the remaining temazepam 10mg to diazepam 5mg giving a total of diazepam 10mg daily. In week 1 convert nitrazepam 5mg straight to diazepam 5mg. In week 1 convert nitrazepam 10mg to nitrazepam 5mg and diazepam 5mg. In week 2 convert the remaining nitrazepam 5mg to diazepam 5mg giving a total of diazepam 10mg daily. In week 1 convert zopiclone 7.5mg straight to diazepam 5mg. In week 1 convert zopiclone 15mg to zopiclone 7.5mg and diazepam 5mg. In week 2 convert the remaining zopiclone 7.5mg to diazepam 5mg giving a total of diazepam 10mg daily. Dose withdrawal may be started when conversion to diazepam is complete. Withdrawal should be gradual e.g. 5-10% reduction every one to two weeks or one-eighth of the dose Guidelines for the management of insomnia_pha08_may

18 fortnightly with a slower reduction at lower doses) and titrated according to the severity of withdrawal symptoms. This may take three to four months to a year or longer. Some people may withdraw in less time 16. Suggested withdrawal schedules for temazepam, nitrazepam and zopiclone without diazepam conversion Withdrawal should be gradual (dose tapering such as 5-10% reduction every one to two weeks or one-eighth of the dose fortnightly with a slower reduction at lower doses and titrated according to the severity of withdrawal symptoms. This may take three to four months to a year or longer. Some people may withdraw in less time. Table 9: Tapering schedules 16 Temazepam 20mg at Reduce daily dose by 2.5mg every two weeks. The target dose for night or less when to stop is when the person is taking only 2.5mg as a daily dose. If stopping is t possible at the target dose offer temazepam liquid 10mg in 5ml and an oral syringe to achieve further reductions. The estimated withdrawal time is sixteen to Nitrazepam 10mg at night or less Zopiclone 7.5mg at night or less twenty weeks or longer. Reduce daily dose by 1.25mg every two weeks. The target dose for when to stop is when the person is taking only 1.25mg as a daily dose. If stopping is t possible at the target dose offer nitrazepam liquid 2.5mg in 5ml and an oral syringe to achieve further reductions. The estimated withdrawal time is sixteen to twenty weeks or longer. Reduce daily dose by 1.875mg every two weeks. The target dose for when to stop is when the person is taking only 1.875mg as a daily dose. If stopping is t possible at the target dose one option is to convert to diazepam to complete the withdrawal, although this is controversial. The estimated withdrawal time is sixteen to twenty weeks or longer. Although some experts have recommended medicine withdrawal over eight to twelve weeks or longer (such as six months), if the person has tried to stop before and failed, the time needed for withdrawal can vary from four weeks to a year or longer 16. Patient management Patients should be reviewed frequently to detect and manage problems early and provide encouragement and reassurance during and after hyptic withdrawal. If anxiety is present, adjunct medicines should t routinely be prescribed. Antidepressants should only be considered if depression or panic disorder co-exist or emerge during drug withdrawal. Consider suspending hyptic withdrawal until depression resolves. Antipsychotics should t be prescribed as these may aggravate withdrawal symptoms. If the patient reaches a difficult point in the hyptic withdrawal schedule, maintain the current dose for a few weeks if necessary. Try to avoid going backwards and increasing the dosage again if possible 3. Patients should be advised hyptic withdrawal should be gradual to minimise the risk of withdrawal effects e.g. three months to a year or longer if necessary. They should also be advised to avoid compensating for benzodiazepines and z-hyptics by increasing the intake of alcohol or other medicines (prescription or -prescription) or illicit substances or smoking 3. Guidelines for the management of insomnia_pha08_may

19 APPENDIX 2 Algorithm for the Assessment and Management of Transient / Short-term Insomnia DETERMINE THE TRUE EXTENT OF INSOMNIA History from patient and carer/relative If the underlying cause is clear, record sleep patterns using chart or sleep diary over period of two weeks ASSESS AND RESOLVE COMMON CAUSES OF INSOMNIA IMPROVE SLEEP HYGIENE - CONSIDER A PSYCHOLOGY REFERRAL LITTLE OR NO RESPONSE IN TWO WEEKS Consider prescription of hyptic short term. Review daily 1 st line: Zopiclone 2 nd line: Temazepam 3 rd line: Zolpidem MONITORING OF RESPONSE TO HYPNOTIC MEDICATION Continue sleep chart monitoring Weekly review to determine need to continue hyptic Individual withdrawal regime once sleep pattern established Guidelines for the management of insomnia_pha08_may

20 APPENDIX 3 Medicines t approved in the trust formulary for the treatment of insomnia (as a main indication). Table 5: Medicines for which management of insomnia would be a n-formulary indication (as main indication). GROUP OF REASONS AND EXPLANATIONS MEDICINES Antidepressants Antipsychotics Antihistamines Diazepam, nitrazepam, flurazepam Chloral hydrate, clomethiazole, barbiturates Oxazepam Melatonin There is limited evidence for efficacy of doxepin, trimipramine, trazodone, paroxetine in insomnia. Antidepressants may affect a wide range of brain receptors and have longer-lasting carry-over effects than traditional hyptic drugs antidepressants are associated with increased risks of road accidents especially early in treatment in depression. Beware of toxicity of tricyclic antidepressants in overdose 1. SSRIs as a class generally disrupt sleep early in course of treatment 1. Taking SSRIs, venlafaxine, mirtazapine increases the risk of restless legs syndrome and periodic limb movements in sleep (PMLS), and SSRIs are kwn to induce or exacerbate sleep bruxism 1. Side effects are common because of the pharmacological actions of these medicines and there are a few reports of abuse. Together these indicate indication for use as first-line treatment 1. Side effects include weight gain, metabolic syndrome, extrapyramidal symptoms and risk of tardive dyskinesia. There are some case reports of abuse of quetiapine in inpatients and prisoners 1. Antipsychotic medicines may have useful sedative effects when prescribed for co-morbidities e.g. depression, mania, schizophrenia and acutely disturbed behaviour. Antihistamines have a limited role in psychiatric and primary care practice for the management of insomnia. These are sedating and can be bought over the counter. These have long duration of action and can often cause drowsiness the following day 1. The sedative effect of antihistamines diminish after a few days of continued treatment. Sideeffects include headache, psychomotor impairment and antimuscarinic effects 2. Promethazine is included in the formulary as an alternative sedative if a patient is tolerant to benzodiazepines in rapid tranquillisation. These are t recommended because their long half-life commonly gives rise to next-day residual effects and repeated doses tend to be cumulative 2. Diazepam may be used in specific circumstances (point 9). Barbiturates and chloral hydrate are toxic in overdose 11. Barbiturate, chloral hydrate, and clomethiazole are t recommended. There is insufficient evidence to support their use and the potential for adverse effects is significant 3. Included in the formulary for off-label use in alcohol detoxification only. A n-formulary application is required for it s licensed indication of a primary sleep disorder. A n-formulary application would be required for the above. Guidelines for the management of insomnia_pha08_may

21 Appendix 4: Equality Impact Assessment Tool Yes/No Comments 1. Does the policy/guidance affect one group less or more favourably than ather on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? n/a n/a n/a n/a Guidelines for the management of insomnia_pha08_may