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POLICY DOCUMENT Document Title Guidance for the Management of Insomnia Policy Type Prescribing and Treatment Guideline Electronic File/Location N:\Pharmacy\Policies, procedures, PGDs, guidances Intranet Location Clinical resources > Pharmacy > Prescribing and treatment guidelines Status Final Version No/Date Version 2 – August 2016 Author(s) Responsible for Lead Pharmacist Mid Writing and Monitoring Approved By and Date Medicines Management Group September 2016 Implementation Date September 2016 Review Date September 2019 © North Essex Partnership University NHS Foundation Trust (2016). All rights reserved. Not to Copyright be reproduced in whole or in part without the permission of the copyright owner. All matters or concerns regarding fraud or corruption should be reported to: Chris Rising, Senior Manager ([email protected] 07768 873701), Mark Kidd LCFS Lead ([email protected] ) Mark Trevallion, LCFS Lead ([email protected] 07800 718680) OR the National Fraud and Corruption Line 0800 028 40 60 https://www.reportnhsfraud.nhs.uk/ IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 1 of 11 Contents Section Topic Page Number 1 Introduction 3 2 Aim 3 3 Scope 3 4 Reference to other standards, policies or procedures 3 5 Guidance 4 5.1 Management strategies 4 5.2 Sleep hygiene (non-pharmacological interventions) 4 5.3 Pharmacological intervention (use of hypnotic agents) 5 5.4 Prescribing for inpatients 6 5.5 Prescribing for patients in the community 7 5.6 Prescribing in the elderly 8 5.7 Long term hypnotic use and stopping hypnotics 8 References 9 6 Appendices 1 Patient information leaflet – stopping hypnotics 10 Summary of Changes Date August 2016 Page number Summary of changes All Reformatted to new template 5 Reference added to choice and medication leaflet 5 Prescriptions for inpatients can be regular or when required and pharmacy will label accordingly but with a note for short term use 7 Table 1 updated to include onset of action 7&8 Prescribing in community and elderly patients added IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 2 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST GUIDANCE FOR THE MANAGEMENT OF INSOMNIA 1. INTRODUCTION 1.1. Insomnia is a disturbance of normal sleep patterns commonly characterised by difficulty in initiating sleep (sleep onset latency) and/or difficulty maintaining sleep (sleep maintenance). 1.2. Insomnia can have a number of different causes: Primary Insomnia is insomnia that can be differentiated from other factors or identifiable causes of sleep disturbance Secondary insomnia is insomnia due to an identifiable cause such as personal circumstances, physical or psychiatric co-morbidity, drug therapy or substance misuse 1.3. Sleep disturbance and the resulting daytime fatigue cause distress and impairment of daytime functioning, both social and occupational, which have been associated with reduced quality of life. 1.4. Sleep disturbances occur in up to 50% of hospitalised patients and can be attributed to both pathophysiological and environmental factors. 1.5. Drugs used to induce sleep will be referred to as ‘hypnotics’. 2. AIM 2.1. The aim of this guidance is to provide prescribing and management advice to staff treating patients with insomnia. It also provides advice on transfer of care in the community. 3. SCOPE 3.1. This guidance applies to all North Essex Partnership University NHS Foundation Trust (NEP) staff treating/caring for patients with insomnia as an inpatient or in the community. 4. REFERENCE TO OTHER STANDARDS, POLICIES OR PROCEDURES NEP Traffic Lights for the Prescribing of Psychotropic Medicines NEP Medicines Policies – Tab 5, Prescribing NEP Medicines Policies – Tab 12, Community Medicines Policy IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 3 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST 5. GUIDANCE 5.1. Management Strategies 5.1.1. The choice of management strategy for insomnia is dependent upon both the duration and nature of the presenting symptoms. 5.1.2. The options for managing insomnia are as follows: Identify potential causes of insomnia such as: underlying illness, drugs (prescribed or bought over the counter) and substance misuse Sleep hygiene Pharmacological intervention 5.1.3. All patients with sleep disturbance should have a documented assessment for potential causes of insomnia and outcomes/actions from this assessment. 5.1.4. Sleep hygiene should be considered the first lane management strategy after ruling out other potential causes and managing those. 5.2. Sleep Hygiene (non-pharmacological interventions) 5.2.1. There is a lack of high quality studies to confirm the effectiveness of nonpharmacological interventions for insomnia. However the use of sleep hygiene as a management strategy is widely supported and recommended. 5.2.2. All patients should be offered an information leaflet from the Choice and Medication website on insomnia and sleep hygiene available here: http://www.choiceandmedication.org/nepft/pdf/handyfactsheetsleephygiene.pdf. This leaflet highlights sleep hygiene options and provides general self-help advice to patients. 5.2.3. The following sleep hygiene approaches should be considered: Increase daily exercise (not in the evening) Do not nap in the daytime Reduce caffeine, nicotine and alcohol intake, especially before bedtime and avoid caffeine after midday Don’t stay in bed for a significant amount of time if you are not sleeping Use anxiety management and relaxation techniques Develop a regular routine of sleeping and waking at the same time each day Avoid looking at screens (phone, computer, television) before going to sleep IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 4 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST Make sure the bedroom environment is quiet and dark and at the right temperature Do not have heavy meals late at night 5.3. Pharmacological Intervention (use of hypnotic agents) 5.3.1. When sleep hygiene and non-pharmacological interventions have not provided satisfactory improvement in sleep, pharmacological intervention should be considered. 5.3.2. Hypnotics can provide relief from the symptoms of insomnia but do not treat the underlying cause. They should be considered somewhat effective for treating sleep onset insomnia but they are ineffective for maintaining sleep. 5.3.3. Hypnotics can be considered for the following patients/scenarios: Short term use following an emotional problem (for example bereavement) or serious medical illness Short term use during hospital stay where the environment may affect sleep Short term use while waiting for treatment of underlying cause to take effect 5.3.4. The following are general guidelines for the prescribing of hypnotics to treat insomnia: Use the lowest effective dose Use intermittent (alternate nights) or ‘when required’ dosing where possible Prescriptions should be for short term (maximum 4 weeks) use in the majority of cases Discontinue slowly after medium to long term use (see below for further information) Be alert for rebound insomnia/withdrawal symptoms Advise patients on the interaction with alcohol and other sedating drugs Avoid the use of hypnotics in patients with respiratory disease, severe hepatic impairment and in addition-prone individuals The risks of prescribing hypnotics in the elderly may outweigh the benefit (see below for further information) Short acting hypnotics are better for sleep onset insomnia but tolerance and dependence develop more quickly Long acting hypnotics are more suitable for patients with frequent or early morning wakening but next day sedation is more likely to occur Tolerance to the effects of hypnotics can develop within 3-14 days of continuous use and long term efficacy cannot be assured IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 5 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST 5.4. Zopiclone, Zolpidem and Zaleplon should be considered equally effective and patients not responding to one, should not be prescribed another unless the patient is suffering from a drug-specific adverse effect If insomnia is associated with daytime anxiety then the use of a long acting drug should be considered as a single dose at night may treat both insomnia and anxiety Prescribing for inpatients 5.4.1. Inpatients should not be routinely prescribed hypnotics on admission without a full assessment for underlying causes of insomnia and the use of sleep hygiene. 5.4.2. If patients are admitted already prescribed a hypnotic, they should be asked how often they use the hypnotic and how long they have taken it for. If the prescriber is satisfied the patient will continue to require the hypnotic as an inpatient it can be prescribed on the drug chart (PMAC) unless it is not recommended (for example nitrazepam could be changed to zopiclone. The prescription and use of the hypnotic should be reviewed after one week. 5.4.3. If the decision is taken not to prescribe the hypnotic, consideration should be given to withdrawal effects. Hypnotics should not be discontinued abruptly and should be gradually reduced. 5.4.4. Hypnotics can be prescribed as regular or ‘when required’ but should state the indication, maximum dose and a weekly review date. 5.4.5. If a patient newly admitted is assessed as needing a hypnotic, the choice of hypnotic should be based on the individual patient, patient preference, local formulary guidance and the advice in Table 1 below and the guidance above. A ‘when required’ prescription is preferred to allow the patient and nursing staff the option of not administering to minimise tolerance and dependence and the prescription should be reviewed weekly. 5.4.6. Named-patient supplies from Pharmacy will be labelled as per the prescription but with an additional label to highlight the recommendation of short term use only. 5.4.7. During their admission and in the build-up to discharge, all patients prescribed hypnotics should have their use reviewed with a view to reducing or stopping. 5.4.8. At the point of discharge, any patients still prescribed a hypnotic should have a clear plan documented in the discharge summary to the GP which states the reason for IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 6 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST prescribing, the expected duration of treatment and a plan to reduce and stop the hypnotic. Drug Usual dose Very short acting Zaleplon 10mg Melatonin Maximum dose* Time until onset (min) Notes 10mg 30 Patients should be advised not to take a second dose during the night Controlled drug schedule 4.1 Pharmacy stock 2mg MR capsules NEP have approved the off-label use of melatonin in children Non-formulary for adults – Form B required 2mg-6mg 10mg day in in children children Short acting Zolpidem 5-10mg Temazepam 10-20mg Unclear 10mg 7 - 27 40mg 30 - 60 (exceptional circumstances) Medium acting Zopiclone 3.75mg 7.5mg 15 - 30 Oxazepam 15-25mg 50mg 20 - 50 Long acting Nitrazepam 5-10mg 10mg 20 – 50 Promethazine 20-50mg 100mg / 24 hours 60 - 120 Drowsiness can persist next day Controlled drug schedule 4.1 Controlled drug schedule 3 Liquid available May have next day drowsiness Controlled drug schedule 4.1 Licensed for insomnia associated with anxiety Suitable in mild-moderate hepatic impairment Controlled drug schedule 4.1 Not recommended Controlled drug schedule 4.1 Antihistamine with multiple indications Risk of antimuscarinic adverse effects Available over the counter Table 1. Choice of hypnotic agents and prescribing guidance * Reduce doses by half to a quarter in the elderly 5.5. Prescribing for patients in the community 5.5.1. When a patient is reviewed in the community, either at a team base as an outpatient or at home or A&E, and it is felt a hypnotic is required, a prescription should be given if needed immediately. IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 7 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST 5.5.2. If the hypnotic is not needed immediately, a recommendation for prescribing should be made to the GP. This should include the choice of hypnotic, dosage instructions, aim of treatment, expected duration and suggested review date with a discontinuation plan if possible. 5.5.3. Patients should be counselled to include the information above, particularly the recommended short term, intermittent use and managing treatment expectations. 5.6. Prescribing in the elderly 5.6.1. As stated above, the risks of treating patients over 60 years of age may outweigh the benefits. Older adults are at greater risk of becoming ataxic and confused which may lead to falls and injury. 5.6.2. When a hypnotic is used to treat an elderly patient, the dose should be reduced to half to a quarter that of the recommended adult dose. 5.6.3. Discontinuation of hypnotics may have beneficial effects on cognition and postural stability. 5.6.4. Older patients prescribed hypnotics should be closely monitored to determine if the prescription continues to be justified. 5.7. Long term hypnotic use and stopping hypnotics 5.7.1. Benzodiazepines and the Z-drugs (zopiclone, zolpidem, zaleplon) are all addictive and can cause craving, tolerance, dependence and withdrawal symptoms. 5.7.2. Withdrawal syndrome can be prolonged and may develop at any time up to 3 weeks after stopping a long acting hypnotic or a few hours after stopping a short acting hypnotic. The withdrawal syndrome includes anxiety, depression, nausea and perceptual changes. Rebound insomnia also occurs and is characterised by a worsening of the original symptoms of insomnia. 5.7.3. The risk of dependency may be increased by short duration of action, long term use, high dose, high potency, alcoholism and other drug dependency, personality disorders and use without medical supervision. 5.7.4. On long term use, hypnotics will produce sleep, but they will reduce or stop rapid eye movement (REM) sleep which is important for feeling refreshed the following day. In the long term this can increase confusion, cause poor short term memory and IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 8 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST an inability to make decisions. Patients may also suffer an increase in early morning wakening as the body attempts to achieve REM sleep. 5.7.5. Healthcare professionals should ensure patients are counselled on the risk of dependence and withdrawal syndromes. The information leaflet in appendix 1 can be used for this purpose and patients should be encouraged to stop using hypnotics with the support of a healthcare professional. 5.7.6. If a hypnotic has been used for less than 4 weeks, it can usually be stopped immediately. 5.7.7. If a hypnotic has been used for longer than 4 weeks, the dose should be gradually reduced to a minimum dose and then introduce intermittent dosing before stopping completely. Intermittent dosing can be achieved through taking a hypnotic on alternate days, only using during the week, only using at weekends etc. 5.7.8. Doses can be reduced at a frequency determined by how well the patient tolerates the reductions. As a guide, this could be weekly to monthly or greater if necessary. 5.7.9. For withdrawal after long term use, it may be possible to switch to an alternative drug that is easier to withdraw such as promethazine. 6. REFERENCES British National Formulary, Edition 70. September 2015. Pharmaceutical Press The Maudsley Prescribing Guidelines in Psychiatry 12th Edition NICE TA77, Guidance on the use of zaleplon, zolpidem and zopiclone for the short term management of insomnia, 2004 IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 9 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST Appendix 1- Patient information leaflet - Stopping Hypnotics Why should I come off sleeping tablets? Everyone has a different sleeping pattern, but a “normal” one will have several periods of light sleep, and deep sleep, and also REM (rapid eye movement) sleep, which is the time your brain uses to process all the information it has taken in during the day before, and process it and “file” it so it is ready for the following day. AWAKE “NORMAL” REM NIGHT’S LIGHT SLEEP WITH FIRST DOSES OF SLEEPING TABLET SLEEP DEEP SLEEP COMA-LIKE SLEEP Sleeping tablets will give your body a rest, and improve sleep, but they do not allow for any REM sleep. They are good for the short term, but without the REM sleep you may still find you feel tired in the morning. Higher doses will make your sleep deeper and longer, but your brain still wants that REM period and in trying to reach it may cause you to suddenly wake up in the early hours. What are the side-effects? In the short-term, you will be less alert, tired in the mornings, and less able to drive or to operate machinery. In the long term you may become dependent on your tablets, and want to take bigger and bigger doses. You may have falls or accidents more often, a poorer memory, and a feeling of not engaging or a lack of emotion. You may take longer to do things. There is a risk of reducing life expectancy. What happens if I stop them? This depends on how long you have been taking them, and everyone is different, but withdrawal has caused Difficulty in getting to sleep or staying asleep Nightmares or vivid dreams Anxiety and restlessness Hot or cold sweats IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 10 of 11 NORTH ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST Panic Changes in your bowel (constipation, diarrhoea, colicky pains) How can I avoid problems with withdrawal? If you have been taking them for less than 4 weeks you should be able to stop straight away. If you have used them for longer, your doctor may change you to a different tablet that is easier to come off. Make a plan to reduce the size of the dose gradually, maybe over weeks or months, then consider tablet-free nights, maybe starting at the weekends and increasing until they have stopped. Involve the people you are close to (partner or carer or friend) to encourage you and to talk to. Can I use tablets in future when I can’t sleep? If all other ways have not worked or you have an urgent need, use them for a short time only (3-5 days) to give you a sleep pattern that works for you. Poor sleep may be a symptom of something else, so do talk to your doctor about it. Driving regulations while on sleeping tablets It’s illegal in England and Wales to drive with legal drugs in your body if it impairs your driving. It’s an offence to drive if you have over the specified limits of certain drugs in your blood and you haven’t been prescribed them. Talk to your doctor about whether you should drive if you’ve been prescribed any of the following drugs: clonazepam clonazepam diazepam flunitrazepam lorazepam methadone morphine or opiate and opioid-based drugs, eg codeine, tramadol or fentanyl oxazepam temazepam You can drive after taking these drugs if: you’ve been prescribed them and followed advice on how to take them by a healthcare professional they aren’t causing you to be unfit to drive even if you’re above the specified limit IntraNEP / Clinical resources / Pharmacy / Prescribing and treatment guidelines Implementation Date: September 2016 Review Date: September 2019 Page 11 of 11