Download Hypnotics Prescribing Review Guidance May 2014 - G-Care

Hypnotics Prescribing Review Guidance
May 2014
v2.1
Written by Chris Llewellyn, Medicines Management Pharmacist
Contents
Audit Guidance p2-p5
References and Appendices p6-p12
Hypnotics Prescribing Review Guidance
May 2014
Background
The prescribing volume of Benzodiazepines and Z-drugs within NHSG CCG is one
of the highest in the South West region. The CCG wish to ensure that patients are
prescribed hypnotic medications appropriately and also to ensure that the smallest
effective dose is prescribed when continued prescribing is required. Secondary to
the prescribing quality outcome objective, this topic also has cost saving implications
in line with NICE technology appraisal, which recommends that the drug of lowest
acquisition cost be used6.
This guidance aims to promote medication review and very careful tapered cessation
of unnecessary hypnotic medications on a case by case basis. As prescribers will be
aware, cessation of regular longer term use must not be abrupt, and an agreed
tapering off period with the patient has been found to be the most successful
approach3. What constitutes long term is not clearly defined and it is important to
note that as little as 3 weeks continuous use may be enough to require gradual
withdrawal in some patients.
Withdrawal can produce rebound insomnia. The patient should be warned that their
sleep may be disturbed for a few days before normal rhythm is re-established.
Broken sleep with vivid dreams may persist for several weeks.
The benzodiazepine withdrawal syndrome may develop at any time up to 3 weeks
after stopping a long-acting benzodiazepine, but may occur within a day in the case
of a short-acting one. It is characterised by insomnia, anxiety, loss of appetite and of
body-weight, tremor, perspiration, tinnitus, and perceptual disturbances. Some
symptoms may be similar to the original complaint and encourage further
prescribing; some symptoms may continue for weeks or months after stopping
benzodiazepines.7
Adverse effects of Hypnotics (which may also arise from short term use) include:
drowsiness and falls; impairment in judgement; increased reaction time;
forgetfulness; confusion; irritability; aggression and excitability; hangover effect;
depression, reduced coping skills; as well as tolerance and dependence.
Also, special Consideration should be given when prescribing in older patients
because of:
 Increased risk of bone fractures due to drowsiness and falls
 Declining renal function and changes to hepatic metabolism leads to
increased sensitivity and more pronounced adverse effects
 Consider the insomnia could be linked to arthritic pain or underlying
depression
A review of the use of Melatonin for insomnia is not intended within this audit as it
has been recently reviewed in a different audit.
New Prescribing for Patients requiring Benzodiazepines or Z-Drugs
Page 2 of 12
A practice wide approach should be agreed.
1. Promote non-pharmacological intervention initially. Prescribing for new
patients should follow consideration of non-drug approach, including use of
the Good Sleep and Good relaxation guides (see appendix 2).
2. Where the insomnia persists beyond use of lifestyle guides, or if medication is
considered necessary for more immediate treatment:
a. Choose in line with Joint Formulary8- first line is Zopiclone
b. Start with low dose in the elderly (Zopiclone 3.75mg) and increase if
necessary. The normal adult dose is 7.5mg at night.
c. Tolerance can develop quickly (within 3-14 days of regular use), so
avoid daily use if possible.
d. Treatment duration should not exceed the licensed use (up to four
weeks use, including the tapering off period)
3. Where zopiclone is not suitable, zolpidem or temazepam are the Joint
Formulary alternatives. Temazepam is more expensive (£20/28) than
Zopiclone (£1.20/28 (DT May 2014))
4. Prescribe the shortest course necessary.
5. Do not put the medication on the repeat screen.
Current Prescribing- Practice Medication Review Approach.
1- Identify patients receiving hypnotics in preference to all benzodiazepines (e.g.
Temazepam, Nitrazepam, Zopiclone, Zaleplon, Zolpidem, Loprazolam,
Lormetazolam, Flurazepam) from the practice computer. (NB all
benzodiazepines could be searched on, but are not specifically included in the
PIP and they may be useful to follow up at a later time)
2- Identify original indication, duration of use, and the medication and dosage
used.
3- Exclusions (indicate exclusion on review sheet for GP information)
a. Severe mental illness- check reasons for medication use, and where
necessary discuss with GP/specialist for advice on whether any
change is suitable and possible.
b. Those being treated by substance misuse service, or thought to be
potential substance misusers.
c. Previous failed withdrawal or reduction.
d. Any patient identified as alcohol misuse (they tend to be more complex
to withdraw).
4- Inclusions
a. Short term use for insomnia/anxiety
b. Irregular use for insomnia/anxiety
c. Long term and/or high dose use for insomnia/anxiety
5- Other suggested audit criteria (for PSP review sheet)
a. Are they a care home patient? (This may help to identify any care
homes which appear to have high use)
b. Any hepatic or renal insufficiency (smaller doses suggested,
accumulation and/or increased sensitivity to hypnotic may occur etc.
means increased chances of ADR)
Page 3 of 12
For excluded patients
Where excluded, raise awareness with the GP as part of the ongoing care. Add an
entry to the computer for future reference e.g. “Hypnotic Medication prescribing
review 2014- excluded from this audit because…” Keeping a record of excluded
patients is important to help the practice to explain continued prescribing for the PIP
2014/15 scheme.
Where a patient is excluded from this review, the following suggested read code
could be used to allow increased ease of follow up reviews:
TPP SystmOneXalp8 (a capital “i” and not a small “L”)
All other Prescribing systems8Q0 (zero)
It would be worthwhile checking for the use of this code prior to use in this audit.
For included patients

All patients should receive a copy of the good sleep/good relaxation guide
(See appendix 2) and encouraged to use it if the recommendations are not
already being carried out. They should also receive a letter informing them of
the practice’s intention to attempt to reduce and/or stop their benzodiazepine
or Z-drug, following a withdrawal regime where necessary. See Appendix for
some sample letters for possible practice adaptation.
Possible options include, but are not limited to Short term (<4 weeks) or irregular use (based on prescription issue history)
o Ensure item is not on repeat
o Advise patient to reduce the dosage they use and the frequency of its
use
o Discontinue when current supply is exhausted, provided that it does not
lead to an abrupt stop. “Tapering off” the dose is recommended. If
necessary consider providing a further small supply to manage this
tapering off period.
o Suggest that further medication to be prescribed only via appointment.

Longer term use (>4weeks)
o Provide Good Sleep and Good Relaxation guides, and encourage
lifestyle changes.
o Request patient to attend as soon as convenient, and certainly within
the next 1-2 months (An example letter is provided in appendix 3).
o Maintain current medication until reviewed at this appointment (may
require a dedicated appointment, rather than trying to review all the
other medications also)
o Amend the repeat medication’s end-date to coincide with the planned
review date (then issue as “acute” after the review, to help improve
monitoring)
o Discuss and agree a tapering off approach with the patient, where
possible, even if it will only achieve a lower regular dose. See appendix
5 for an example of a tapering schedule3.
o Tapering off should in most cases be manageable with the same
medication (meaning one less change for the patient to make)3.
Page 4 of 12
o Where necessary, consider conversion to diazepam (which has a long
half-life, which makes withdrawal effects less likely when tapering off)
and then follow a gradual reducing programme.
Further information relating to the types of dose reduction schedules suggested can
be found on Clinical Knowledge Summaries1 where you can find more in depth
examples (it may be unlikely that one schedule will work for all patients), as well as
the BNF3, which has a suggested withdrawal schedule.
Where a patient is reviewed and needs to continue, consider where possible a
controlled move to Z-drugs (whichever is appropriate for the patient). While
medication review is the primary aim of this review, reducing costs is also beneficial.
Any reduction in dose will help to reduce the possible adverse effects from these
medicines. Conversion to Z-drug ‘equivalent’ dose should be done over a period of
time using the table in Appendix 1 as a guide. Where continued use is warranted, the
read code appropriate for the computer system in use in the practice should be
added to the patient’s record to confirm that appropriate review has been carried out.
In all cases, consider whether sleep hygiene has been attempted initially where
possible. Other methods of sleep preparation such as dietary and lifestyle changes
are important (e.g. reduce caffeine intake, reduce sugar intake, avoiding “working” or
exercising within a few hours of bedtime).
Even if these measures are unsuccessful alone, they may allow for a reduced dose
of hypnotic to be effective.
Page 5 of 12
References and Resources
123-
4-
56-
789-
Clinical Knowledge Summaries http://cks.nice.org.uk/benzodiazepine-and-z-drugwithdrawal#!scenariorecommendation (accessed 8.5.14)
Clinical Knowledge Summaries http://cks.nice.org.uk/benzodiazepine-and-z-drugwithdrawal#!scenarioclarification (accessed 8.5.14)
Hypnotics and Anxiolytics Practice Guide (Wales Health Board)
http://www.wales.nhs.uk/sites3/Documents/582/Guide_Hypnotics%20%26%20Anxiolytics%20Pr
actice%20Guide_version02.pdf (accessed 8.5.14)
NHS Stockport Hypnotic Guidance https://www.google.co.uk/url?q=http://stockportccg.org/wpcontent/uploads/2012/07/Good-Hypnotic-Prescribing-Guide-November2012.doc&sa=U&ei=VH5rU4SnN46rOrC_gbgM&ved=0CB4QFjAA&usg=AFQjCNFgTGL6E2fZ3d
xJRhEu1hEYsq9GwA
http://www.patient.co.uk/doctor/Benzodiazepine-Dependence.htm (accessed 8.5.14)
NICE TA77 Guidance on the use of Zaleplon, zolpidem and zopiclone for the short term
management of insomnia http://publications.nice.org.uk/guidance-on-the-use-of-zaleplonzolpidem-and-zopiclone-for-the-short-term-management-of-insomnia-ta77/implications-for-thenhs
BNF online version accessed 14.5.14
NHS Gloucestershire Joint Formulary http://www.formulary.glos.nhs.uk/ (accessed 14.5.14)
The Ashton Manual (accessed 14.5.14) and linked to from Clinical Knowledge Summaries
http://www.benzo.org.uk/manual/bzsched.htm
Appendix 1
Hypnotics comparison chart - including diazepam & zopiclone equivalents:
Drug Name
Usual
dosage
range
Diazepam
5mg
Loprazolam
1-2mg
Lorazepam
1-2.5mg
Lormetazepam 0.5-1mg
Nitrazepam
5mg
Temazepam
10-20mg
Zaleplon
5-10mg
Zopiclone
3.75-7.5mg
Zolpidem
5-10mg
Cost per 28
days (DT May
2014)
£0.83
£18-£36
£2.45-£6.12
£15.30-£30.60
£1.83
£19.64-£20.55
£6.24-£7.52
£1.20
£1.45-£1.58
Page 6 of 12
Dose equivalent
to Diazepam
5mg
5mg
0.5-1mg
0.5mg
0.5-1mg
5mg
10mg
10mg
3.75mg
10mg
Half Life (hrs)
[active
metabolite]
20-100 [36-200]
6-12
10-20
10-12
15-38
8-22
2
5-6
2-4
Appendix 2
The ‘Good Sleep Guide’
The following tips should help you get into a good sleep pattern:
During the Evening
1. Put the day to rest. Tie up loose ends in your mind. A notebook may
help.
2. Take some light exercise in the early evening e.g. go for a walk.
3. Wind down in the course of the evening. Try and avoid anything mentally
demanding within 90 minutes of bedtime.
4. Don’t sleep or doze on the sofa.
5. Avoid drinks such as coffee/tea/cola after 6pm. These contain caffeine
and can keep you awake.
6. Make your bedroom comfortable. Not too cold or hot.
At Bedtime
1. Go to bed when you are “sleepy tired”.
2. Do not watch TV in bed.
3. Set the alarm for the same time every day until your sleep pattern
settles.
4. Put the lights out when you get in to bed.
5. Try a relaxing drink such as camomile, Horlicks™ or Ovaltine™ before
bed.
6. Enjoy relaxing even if at first you don’t fall asleep.
If you have problems getting to sleep
1. Remember that sleep problems are common and not as damaging as
you might think.
2. If you are awake for more than 20 minutes then get up and go into
another room.
3. Do something relaxing and don’t worry about tomorrow.
4. People usually cope quite well after a restless night. Try reading a
magazine or book.
5. Go back to bed when you are “sleepy tired”.
6. Remember the tips from the above section.
A good sleep pattern may take a number of weeks to establish. If you have had
problems for years then it will take longer. Be confident that you will get there in the
end.
(Adapted from original work by Dr Colin Espie)
Page 7 of 12
The ‘Good Relaxation Guide’
Dealing with Physical Tension
 Value times of relaxation. Think of them as essentials not extras. Give relaxation
some of your time not just what’s left over.
 Build relaxing things into your lifestyle every day and take your time. Don’t rush.
Don’t try too hard.
 Learn a relaxation routine, but don’t expect to learn without practice.
 There may be relaxation routines available, especially in audio format. These
help you to reduce muscle tension and to learn how to use your breathing to help
you relax.
 Tension can show in many different ways – aches, stiffness, heart racing,
perspiration, stomach churning, etc. Don’t be worried about this.
 Keep fit. A walk or a swim can help to relieve tension.
Dealing with Worry
 Accept that worry can be normal and that it can be useful. Some people worry
more than others but everyone worries sometimes.
 Write down your concerns. Decide which ones are more important by rating each
out of ten.
 Work out a plan of action for each problem.
 Share your worries. Your friends or your general practitioner can give you helpful
advice.
 Doing crosswords, reading, taking up a hobby or an interest can all keep your
mind active and positive.
 You can block out worrying thoughts by mentally repeating a comforting phrase.
 Practice enjoying quiet moments, e.g. sitting listening to relaxing music. Allow
your mind to wander and try to picture yourself in pleasant, enjoyable situations.
Dealing with Difficult Situations
 Try to build your confidence. Try not to avoid circumstances where you feel more
anxious. A step by step approach is best to help you face things and places
which make you feel tense. Regular practice will help you overcome your anxiety.
 Make a written plan and decide how you are going to deal with difficult situations.
 Reward yourself for your successes. Tell others. We all need encouragement.
 Your symptoms may reduce as you face up to difficult situations. Keep trying and
they should become less troublesome as your confidence grows.
 Everyone has good and bad days. Expect to have more good days as time goes
on.
 Try to put together a programme based on all the elements in “The Good
Relaxation Guide” that will meet the needs of your particular situation. Remember
that expert guidance and advice is available if you need further help.
(Adapted from material originally prepared by Dr Colin Espie)
Page 8 of 12
Appendix 3 - Example withdrawal letters for local adaptation
Patient led withdrawal.
Prescriber’s
Name
Practice Name
Practice Address
Patient Name
Patient Address
Date
Dear Mr/Mrs/Ms,
We are currently reviewing all our patients who take the medication…(Insert drug
name)…… This drug is from a group of drugs known as …..(benzodiazepines/ zdrugs) delete as appropriate….., which when taken for a prolonged length of time
can have negative adverse effects:
•
Dependence on the drug
•
Reduced alertness may lead to accidents or falls
•
Poorer memory
•
Lack of emotion
•
Tasks take longer to complete
•
Poor sleep quality
Importantly, after long term use, these tablets may actually cause anxiety and
sleeplessness and they can be addictive. For these reasons we would like you to
consider reducing your use of your benzodiazepine.
Do not stop taking suddenly as this may cause unwanted side effects, possibly
anxiety, restlessness and problems sleeping. It is recommended to cut down
gradually to reduce the likelihood of side effects. Try cutting down fortnightly when
possible, the best way is to use your medication only when absolutely necessary.
Your surgery will be able to advise you on how to reduce.
Once you have been able to cut down, you might start to think about stopping
altogether. If you do experience unwanted side effects reduce at a slower rate such
as monthly.
A ‘Good sleep guide’ has been included with this letter. Your local library will also
have a selection of self-help books on improving sleep or combating anxiety and
stress. A useful website is:
http://www.rcpsych.ac.uk/mentalhealthinfoforall/problems/sleepproblems/sleepingwel
l.aspx
If you have any queries regarding this change, please contact the surgery and
arrange to speak to your regular GP or the practice’s support pharmacist.
Yours sincerely
Page 9 of 12
GP Practice led withdrawal via appointment.
Prescriber’s
Name
Practice Name
Practice Address
Stockport
Patient Name
Patient Address
Date
Dear Mr/Mrs/Ms,
We are currently reviewing all our patients who take the medication…(Insert drug
name)…… This drug is from a group of drugs known as …..(benzodiazepines/ zdrugs) delete as appropriate….., which when taken for a prolonged length of time
can have negative adverse effects:
•
Dependence on the drug
•
Reduced alertness may lead to accidents or falls
•
Poorer memory
•
Lack of emotion
•
Tasks take longer to complete
•
Poor sleep quality
Importantly, these tablets may actually cause anxiety and sleeplessness and they
can be addictive. For these reasons we would like to discuss reducing your use of
your benzodiazepine. Do not stop taking this suddenly as this may cause unwanted
side effects, possibly anxiety, restlessness and problems sleeping.
Please make an appointment with your GP (or practice pharmacist) in the near future
to discuss reducing your medication gradually to reduce the likelihood of side effects.
A ‘Good sleep guide’ has been included with this letter. Your local library will also
have a selection of self-help books on improving sleep or combating anxiety and
stress. A useful website is:
http://www.rcpsych.ac.uk/mentalhealthinfoforall/problems/sleepproblems/sleepingwel
l.aspx
If you have any queries regarding this change, please contact the surgery and
arrange to speak to your regular GP or the practice’s support pharmacist.
Yours sincerely
Page 10 of 12
Appendix 4
Patient Information Leaflet: Reducing Your Sleeping (Hypnotics) Tablets
(4)
Sleeping tablets should only be used for short periods of time, used in the long term there
can be unwanted side effects. If used for longer than 2-4 weeks your body can become used
to their effects and the medication may not work as well as it did at first. They should only be
used to get back into normal sleeping pattern.
You may experience the following negative effects from using hypnotics
In the short term:
 Reduced alertness
 Drowsiness
In the long term:
 Dependence on the drug
 Reduced alertness may lead to accidents or falls
 Poorer memory
 Lack of emotion
 Short term effects may continue
Possible withdrawal symptoms that might arise when reducing or stopping:
 Your muscles may ache and you may feel strange sensations on your skin
 You may feel restless and anxious
 You may feel sick and weight loss may occur
 You may have difficulty sleeping
 You may feel frightened or panicky
 Eventually your anxiety will disappear and you will become more assertive
These arise because sleeping tablets block your emotional responses. When the drug is
stopped your brain becomes over stimulated and this can lead to heightening of feelings and
senses.
Once stopped
 You should find that you get a better quality of sleep
 You are more alert especially in the mornings
 Your memory improves
 You feel more confident and assertive
Facts about Sleep
 Sleep duration varies from day to day. As people get older they require less sleep
 It is normal for an older person to wake several times in the night. This isn’t harmful.
Being in bed resting can be as good as sleep
 A good night’s sleep may follow a sleepless night, without the need to resort to a
sleeping tablet
Page 11 of 12
Appendix 5
Example of a ‘tapering to zero’ schedule and chart for patient use, based on long
term 10mg Temazepam daily3. Enter day one name e.g. Mon. Tues. etc. between
the brackets.
For doses greater than 10mg, doses should be converted to multiple of10mg tablets
e.g. 2x10mg to avoid confusion when using the chart. Subsequent extra rows would
need inserting to allow the reduction from 2x10mg to 1½ x10mg to 1x10mg etc.,
where the chart below could then be used).
Day 1 (
)
Day 2 (
)
Day 3(
)
Day 4 (
)
Day 5 (
)
Day 6 (
)
Day 7 (
1st week
1
1
1
½
1
1
1
2nd week
½
1
1
1
½
1
1
rd
3 week
½
1
1
½
1
1
½
4th week
1
½
1
½
1
½
½
5th week
1
½
½
1
½
½
½
6 week
½
½
½
½
½
1
½
7th week
½
½
½
½
½
½
½
8th week
½
½
½
0
½
½
½
9th week
½
½
0
½
0
½
½
10 week
½
0
½
0
½
0
½
11th week
½
0
½
0
0
½
0
12th week
0
½
0
0
½
0
0
th
th
13th week
)
Stop Temazepam
Alternatively, the BNF recommends a benzodiazepine withdrawal schedule based on
a dose equivalent transfer to diazepam first and then dose reductions of
approximately one eighth every two weeks. If withdrawal symptoms occur, maintain
the dose until symptoms improve and then recommence dose reductions.
Withdrawing Zopiclone
The withdrawal of zopiclone can be achieved using a method similar to that as for
Temazepam withdrawal above, with small reductions of 1.875mg (half a 3.75mg
tablet)2.
Alternatively the Ashton Manual9 contains detailed reduction schedules involving
conversion to diazepam.
Page 12 of 12