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Transcript
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
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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