PROCEDURE REF NO SABP/EXECUTIVE BOARD/0017 NAME OF GUIDELINE REASON FOR GUIDELINE WHAT THE GUIDELINE WILL ACHIEVE? WHO NEEDS TO KNOW ABOUT IT? Medicines Guideline: Hypnotic Medication Compliance with NICE TA Guidance 77 1. Reduce prescribing of unnecessary hypnotic medication 2. Reduce duration of prescribing of hypnotic medication 3. Increase awareness of sleep hygiene measures All staff involved in prescribing, dispensing, distributing and administering medication DATE APPROVED 7 th December 2017 VERSION NUMBER 3.0 APPROVING COMMITTEE Executive Board DATE OF IMPLEMENTATION 5 th January 2018 DATE OF FORMAL REVIEW December 2020 AUTHOR/REVIEWER: RESPONSIBLE DIRECTORATE DISTRIBUTION Medicines Management Committee Medical Directorate All staff involved in prescribing, dispensing, distributing and administering medication This policy has been reviewed and is compliant with the most up to date Code of Practice and NICE Guidelines TITLE OF CODE OF PRACTICE NICE REFERENCE NUMBER TA77 Page 1 of 7
VERSION CONTROL SHEET Version Date Author Status Comment 1 7/07/10 Fiona Approved 1.1 05/01/16 Fiona Draft 2.0 07/01/16 Fiona Approved 2.1 June 2017 Fiona Draft 3.0 December 2017 Fiona Approved Page/Paragraph/ Appendix Number (select the appropriate action) Summary of Changes since Version 2 Original / New / Amendment / Deleted Statement (select the appropriate action) 3.11 Within the Trust, zolpidem is the current hypnotic of choice. Amendment 3.12 Prescribers are reminded that the maximum licensed dose of zopiclone for an adult is 7.5mg or 3.75 7.5mg at night for older adults. Deleted 3.13 There is evidence that benzodiazepines with a shorter half-life e.g. lorazepam have a higher dependence potential than longer acting agents e.g. diazepam. Deleted 4.0 REFERENCES NICE TA Guidance 77 2004: Zaleplon, zolpidem and zopiclone for the short-term management of insomnia Deleted 4.0 New 5.0 New 6.0 New 7.0 New Page 2 of 7
HYPNOTIC MEDICATION GUIDELINES 1.0 INTRODUCTION 1.1 The aim of these guidelines is to ensure that benzodiazepines and other hypnotic drugs (e.g. the Z-hypnotics zopiclone, zaleplon and zolpidem) are prescribed appropriately and reviewed regularly to prevent dependence and withdrawal problems. 1.2 Dependence, (physical and psychological) and tolerance can occur if these drugs are taken regularly for more than a few weeks and this may lead to difficulty in stopping the drug. 1.3 They should be reserved for short courses to alleviate severe, disabling symptoms. 1.4 Chronic insomnia is rarely benefited by long-term prescribing of these medications. 1.5 The Committee of Safety of Medicines issues the following advice: Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or subjecting the individual to extreme distress. 1.6 The Z-hypnotics are not licensed for long-term use and are now known to have similar dependence problems. 2.0 RELATED POLICY The Medicines Policy 3.0 GUIDELINES 3.1 Exploring sleep difficulties should be an integral part of the patient history taking process. 3.2 Prior to initiating pharmacological treatment, consideration should be given to: Other mental health diagnoses e.g. acute mania, which should be treated appropriately. Page 3 of 7
Sleep hygiene measures (see Appendix 1) e.g. address excessive caffeine intake, being mindful of related issues such as caffeine withdrawal symptoms and changes in plasma levels of concomitant medication such as clozapine. Other medication that may cause insomnia e.g. SSRIs and procyclidine administered at night. 3.3 Clinicians should be aware if, and for how long a patient has been on hypnotics and whether they are being taken regularly or intermittently. 3.4 After taking the clinical picture into consideration, stopping the hypnotic may be an option: If a patient has been taking the hypnotic for longer than four weeks it should not be stopped abruptly as this may precipitate withdrawal symptoms. Discontinuation should be planned and gradual over at least 4-6 weeks (longer in some cases). 3.5 It should be documented in the notes that the above issues have been discussed before prescribing any hypnotics. 3.6 When prescribing hypnotics: Keep in strict accordance with their licensed indications. Limit the prescription initially to no more than 7 days then review. Set down a clear indication in the patient s notes for prescribing with an appropriate review date. State the review/stop date clearly on the prescription card. Consider intermittent use (every 2 nd /3 rd night) to help prevent tolerance developing. Switching from one to another should only occur if a patient experiences adverse effects directly related to a specific agent. Patients who have not responded to one agent should not be prescribed any of the other treatments that act at the benzodiazepine receptor. Do not write up PRN (as required) prescriptions of hypnotics for all patients on admission in case they may be required at a later time. (See Medicines Guideline: PRN Medication in In-patient Settings) 3.7 There may be exceptional cases where patients with severely disabling symptoms are prescribed longer courses of hypnotics under the supervision of a consultant. Page 4 of 7
3.8 Specific risks should be taken into consideration e.g. diversion, addiction and overdose in susceptible patient groups. 3.9 The suitability of benzodiazepines, especially long-acting, should be taken into consideration in certain patient groups, e.g. older adults, patients with hepatic impairment. 3.10 At discharge, all hypnotic prescriptions should be reviewed, especially where they have been initiated during a hospital admission. 3.11 Within the Trust, zolpidem is the current hypnotic of choice. 3.12 Clinical teams should regularly audit their prescribing of benzodiazepines and other hypnotic drugs. 4.0 PRESCRIBING INFORMATION FOR ZOLPIDEM 4.1 Dose: 10mg ON; maximum 4 weeks duration Elderly, 5mg ON Hepatic impairment, 5mg ON 4.2 Precautions: Combination with CNS depressants: Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. Concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability. CYP450 inhibitors and inducers: Co-administration of ciprofloxacin may increase blood levels of zolpidem tartrate, concurrent use is not recommended. Since CYP3A4 plays an important role in zolpidem tartrate metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered. Page 5 of 7
5.0 RISKS ASSOCIATED WITH HYPNOTICS Falls Cognitive impairment Dependence Withdrawal symptoms Increased risk of dementia Impaired ability to drive 6.0 DRUGS AND DRIVING 6.1 A new offence of driving with certain controlled drugs above specified limits in the blood came into force in March 2015. Prescription drugs covered by the new offence include amfetamine, clonazepam, diazepam, flunitrazepam, lorazepam, methadone, morphine or opioid-based drugs, oxazepam and temazepam. 6.2 The risk of next-day psychomotor impairment, including impaired driving ability, is increased if zolpidem tartrate is taken within less than 8 hours before performing activities that require mental alertness. 7.0 REFERENCES NICE TA Guidance 77 2004: Zaleplon, zolpidem and zopiclone for the short-term management of insomnia SPC: Stilnoct 10mg tablets NICE advice: Hypnotics 15 Jan 2015 KTT6 Page 6 of 7
Appendix 1 Having Trouble Sleeping Leaflet Page 7 of 7