Download Hypnotics in clinical practice - South West Yorkshire Partnership

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
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South West Yorkshire Partnership NHS Foundation Trust
HYPNOTICS IN CLINICAL PRACTICE SUMMARY SHEET Version 4 August
2012
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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