Hypnotics in Clinical Practice

Document name: / Hypnotics in Clinical
Version 5
Portfolio / Medicines Management
Document type: / 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: /
Tel 01924 327619

South West Yorkshire Partnership NHS Foundation Trust

Abbreviations used in this document:

BNF / British National Formulary
CCG / Clinical Commissioning Group
CD / Controlled Drug
CSM / Committee on Safety of Medicines (Commission on Human Medicines)
DVLA / Drivers Vehicle Licensing Agency
GI / Gastro-Intestinal
GP / General Practitioner
NICE / National Institute for Health and Clinical Excellence
NSF / National Service Framework
PCT / Primary Care Trust
SMRC / Scottish Medicines Resource Centre
SPC / Summary of Product Characteristics
SWYPFT / South West Yorkshire Partnership NHS Foundation Trust

Contents

HYPNOTICS IN CLINICAL PRACTICE SUMMARY SHEET June 2010.

1 INTRODUCTION

3

2 BACKGROUND INFORMATION

3 2.1 Sleep disturbance ......

3 2.2 Sleep hygiene measures ......

4 2.3 About sleep ......

4

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 ………………….

PATIENTS ON LONG TERM TREATMENT

REFERENCES

APPENDICES

/
/

Appendix 1: Sleep Diary

Appendix 2: Withdrawal from Benzodiazepines

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 Oxazepam 10 to 25mg at night for insomnia associated with anxiety

o Promethazine 25 to 50mg at night where other hypnotics are not suitable.

o Temazepam 10 to 20mg - restricted to existing users

o 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)

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

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 90-100 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).

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.

SHORT TERM (Preferably intermittent) use only

Zopiclone 3.75 - 7.5mg at bedtime

Start at 3.75mg for elderly

Zolpidem 5 to 10mg at night at bedtime

Start at 5mg for the elderly and debilitated

Lorazepam 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.