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

HypnoticsPrescribing 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

A practice wide approach should be agreed.

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).
Where the insomnia persists beyond use of lifestyle guides, or if medication is considered necessaryfor more immediate treatment:
Choose in line with Joint Formulary8- first line is Zopiclone
Start with low dose in the elderly (Zopiclone 3.75mg) and increase if necessary. The normal adult dose is 7.5mg at night.
Tolerance can develop quickly (within 3-14 days of regular use), so avoid daily use if possible.
Treatment duration should not exceed the licensed use (up to four weeks use, including the tapering off period)
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))
Prescribe the shortest course necessary.
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)

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.
Those being treated by substance misuse service, or thought to be potential substance misusers.
Previous failed withdrawal or reduction.
Any patient identified as alcohol misuse (they tend to be more complex to withdraw).

4-Inclusions

Short term use for insomnia/anxiety
Irregular use for insomnia/anxiety
Long term and/or high dose use for insomnia/anxiety

5-Other suggested audit criteria(for PSP review sheet)

Are they a care home patient? (This may help to identify any care homes which appear to have high use)
Any hepatic or renal insufficiency (smaller doses suggested, accumulation and/or increased sensitivity to hypnotic may occur etc. means increased chances of ADR)

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 SystmOne-Xalp8 (a capital “i” and not a small “L”)

All other Prescribing systems-8Q0 (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 intentionto 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)
Ensure item is not on repeat
Advise patient to reduce the dosage they use and the frequency of its use
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.
Suggest that further medication to be prescribed only via appointment.

Longer term use (>4weeks)
Provide Good Sleep and Good Relaxation guides, and encourage lifestyle changes.
Request patient to attend as soon as convenient, and certainly within the next 1-2 months (An example letter is provided in appendix 3).
Maintain current medication until reviewed at this appointment (may require a dedicated appointment, rather than trying to review all the other medications also)
Amend the repeat medication’s end-date to coincide with the planned review date (then issue as “acute” afterthe review, to help improve monitoring)
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.
Tapering off should in most cases be manageable with the same medication (meaning one less change for the patient to make)3.
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.

References and Resources

1-Clinical Knowledge Summaries 8.5.14)

2-Clinical Knowledge Summaries (accessed 8.5.14)

3-Hypnotics and Anxiolytics Practice Guide (Wales Health Board) (accessed 8.5.14)

4-NHS Stockport Hypnotic Guidance

5- (accessed 8.5.14)

6-NICE TA77 Guidance on the use of Zaleplon, zolpidem and zopiclone for the short term management of insomnia

7-BNF online version accessed 14.5.14

8-NHS Gloucestershire Joint Formulary (accessed 14.5.14)

9-The Ashton Manual (accessed 14.5.14) and linked to from Clinical Knowledge Summaries

Appendix 1

Hypnotics comparison chart - including diazepam & zopiclone equivalents:

Drug Name / Usual dosage range / Cost per 28 days (DT May 2014) / Dose equivalent to Diazepam 5mg / Half Life (hrs) [active metabolite]
Diazepam / 5mg / £0.83 / 5mg / 20-100 [36-200]
Loprazolam / 1-2mg / £18-£36 / 0.5-1mg / 6-12
Lorazepam / 1-2.5mg / £2.45-£6.12 / 0.5mg / 10-20
Lormetazepam / 0.5-1mg / £15.30-£30.60 / 0.5-1mg / 10-12
Nitrazepam / 5mg / £1.83 / 5mg / 15-38
Temazepam / 10-20mg / £19.64-£20.55 / 10mg / 8-22
Zaleplon / 5-10mg / £6.24-£7.52 / 10mg / 2
Zopiclone / 3.75-7.5mg / £1.20 / 3.75mg / 5-6
Zolpidem / 5-10mg / £1.45-£1.58 / 10mg / 2-4

Appendix 2

The ‘Good Sleep Guide’

The following tips should help you get into a good sleep pattern:

During the Evening

Put the day to rest. Tie up loose ends in your mind. A notebook may help.
Take some light exercise in the early evening e.g. go for a walk.
Wind down in the course of the evening. Try and avoid anything mentally demanding within 90 minutes of bedtime.
Don’t sleep or doze on the sofa.
Avoid drinks such as coffee/tea/cola after 6pm. These contain caffeine and can keep you awake.
Make your bedroom comfortable. Not too cold or hot.

At Bedtime

Go to bed when you are “sleepy tired”.
Do not watch TV in bed.
Set the alarm for the same time every day until your sleep pattern settles.
Put the lights out when you get in to bed.
Try a relaxing drink such as camomile, Horlicks™or Ovaltine™ before bed.
Enjoy relaxing even if at first you don’t fall asleep.

If you have problems getting to sleep

Remember that sleep problems are common and not as damaging as you might think.
If you are awake for more than 20 minutes then get up and go into another room.
Do something relaxing and don’t worry about tomorrow.
People usually cope quite well after a restless night. Try reading a magazine or book.
Go back to bed when you are “sleepy tired”.
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)

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)

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/ z-drugs) 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:

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

GP Practice led withdrawal via appointment.

Prescriber’s Name

Practice Name

Practice Address

Stockport

Patient Name

Patient Address

Date

Dear Mr/Mrs/Ms,

•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:

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

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: