Appropriate use of zopiclone and benzodiazepines for the treatment of insomnia
In this Audit 
Audit Focus
Zopiclone and some benzodiazepines, such as temazepam and triazolam, are indicated for the short-term treatment of insomnia
(i.e. four weeks or less). Long-term use of these medicines should be avoided where possible due to adverse effects and
the potential for the development of dependence. The objective of the audit is to promote appropriate use of these medicines,
particularly for those who are using these medicines long-term. Advice about the risks and adverse effects of these medicines
and guidance on withdrawal should be given to all patients who receive prescriptions for these medicines.
Background
Zopiclone and some benzodiazepines although widely used, are not the preferred option for the long-term treatment of
insomnia. Cognitive-behavioural approaches (e.g. “sleep hygiene”) are safer, have high levels of efficacy, are supported
by a good evidence base, and achieve better outcomes in the long-term. In addition, these medicines have the potential
for dependency and can cause a range of adverse effects, e.g. muscle weakness, vertigo, effects on cognition including
an increased risk of dementia.
These effects can lead to adverse clinical outcomes, such as an increased risk of falls and increased risk of motor
vehicle accidents. Elderly patients have reduced clearance of medicines and are likely to require a lower dose to minimise
adverse effects. Discontinuing the use of zopiclone or a benzodiazepine may reverse some of these effects, e.g. improving
motor performance, cognition and reducing the risk of dementia. Concomitant use of benzodiazepines or zopiclone with opioids
or alcohol increases many risks, such as lack of judgement, sexual disinhibition, criminal activity and fatal overdose.
If other interventions to improve sleep have been unsuccessful, zopiclone or a short-acting benzodiazepine should be
chosen and prescribed at the lowest effective dose for a short duration, ideally no more than four weeks, and preferably
five to ten days. Prior to starting the medicine, patients should be given information about adverse effects and educated
about the importance of not becoming reliant on these medicines. They should understand that they are for short-term use
only. Many patients request further repeat prescriptions for hypnotics because they perceive that the rapid symptom relief
that is often gained when using these medicines outweighs any adverse effects and risks. Prescriptions for zopiclone or
benzodiazepines should therefore be written to take account of the risk of uncontrolled and escalating use, i.e. prescribed
in limited quantities with regular review. However, there are no clear clinical guidelines regarding the appropriate medicine-free
interval between short courses of hypnotics.
Prescribers should also be vigilant for drug-seeking behaviour, such as early requests for repeat prescriptions.
Patients who have been using these medicines long-term should be counselled against continuing use. Interventions to
assist patients to withdraw include psychological support and counselling for underlying or concurrent problems they may
have, regular follow-up appointments, e.g. fortnightly, patient information leaflets and reminder letters for patients
regarding the risks of ongoing use.
For further information on benzodiazepine and zopiclone withdrawal strategies,
see: www.bpac.org.nz/BPJ/2015/February/benzodiazepines.aspx
Note – Rapid withdrawal of benzodiazepines is associated with an increased risk of seizures, therefore patients who
have been using these medicines long-term should be counselled against stopping their use abruptly.
Recommendation
Zopiclone and short-acting benzodiazepines should only be used on a short-term basis for the treatment of insomnia.
Alternative non-pharmacological methods to improve sleep quality should have been discussed and ideally trialled. Patients
should be advised of the adverse effects of these medicines and the potential for dependency. If patients have been using
these medicines long-term, they should be counselled regarding the risks associated with their use and offered support
and advice to assist with withdrawal. These discussions should be documented in clinical notes.
Audit plan
- Select a random sample of patients who have recently been prescribed zopiclone, temazepam or triazolam (as these latter
benzodiazepines are used principally for the treatment of insomnia).
- Review the patient notes to establish if a conversation with the patient has been documented in which:
- The patient has been advised of the potential for dependence with the use of these
medicines
- The patient has been counselled about other methods for the management of insomnia
- If the medicines have been taken on an ongoing basis, the patient has been advised
to discontinue use and supported to do so
Standards
Ideally 100% of patients prescribed zopiclone, temazepam or triazolam will have been counselled regarding the risks
of using these medicines and the conversation documented in the notes. All patients who have been using these medicines
for periods longer than recommended should have been provided with advice on withdrawal and of alternative methods to
promote sleep. However, for the purposes of this audit a target of 90% of patients with documented conversations is suggested.
Data
Identifying patients
Search for patients who have been prescribed zopiclone, temazepam or triazolam in a recent month. Zopiclone is likely
to be the most frequently prescribed hypnotic, but the audit should include temazepam and triazolam because they are the
benzodiazepines used principally for the treatment of insomnia.
Sample size
The number of eligible patients will vary from practice to practice. Ideally sample size should be “all patients prescribed
zopiclone, triazolam or temazepam in a selected month”. However, this may generate too large a sample size for some practices,
and too small in others. If your practice has a large number of patients being prescribed these medicines, take the first
20 results returned from a search. If your practice has small numbers of patients prescribed these medicines, extend the
search to include more than the previous month to allow the sample size to reach 20.
Review patient notes
Review the patient notes to establish if a conversation with the patient has been documented in which:
- The patient has been advised of the potential for dependence with the use of these
medicines
- The patient has been counselled about other methods for the management of insomnia
- If the medicines have been taken on an ongoing basis, the patient has been advised
to discontinue use and supported to do so
Criteria for a positive result
In order to score a positive result in this audit, patients prescribed zopiclone, temazepam or triazolam for the treatment
of insomnia should have documentation of a conversation regarding risks and adverse effects of these medicines, including
dependence and alternative methods to manage their insomnia. If they have been prescribed these medicines on an ongoing
basis there should also be a documented conversation where the patient has been counselled regarding discontinuation.
Identifying opportunities for Audit of Medical Practice
The first step to improving medical practice is to identify the criteria where gaps exist between expected and actual
performance and then to decide how to change practice.
Once a set of priorities for change have been decided on, an action plan should be developed to implement any changes.
Taking action
It may be useful to consider the following points when developing a plan for action (RNZCGP 2002).
Problem solving process
- What is the problem or underlying problem(s).
- Change it to an aim.
- What are the solutions or options?
- What are the barriers?
- How can you overcome them?
Overcoming barriers to promote change
- Identifying barriers can provide a basis for change.
- What is achievable – find out what the external pressures on the practice are and discuss ways of dealing with them
in the practice setting
- Identify the barriers
- Develop a priority list
- Choose one or two achievable goals
Effective interventions
- No single strategy or intervention is more effective than another, and sometimes a variety of methods are needed to
bring about lasting change
- Interventions should be directed at existing barriers or problems, knowledge, skills and attitudes, as well as performance
and behavior
Review
Monitoring change and progress
It is important to review the action plan against the timeline at regular intervals with the practice team. It may be
helpful to discuss the following questions:
- Is the process working?
- Are the goals for improvement being achieved?
- Are the goals still appropriate?
- Do you need to develop new tools to achieve the goals you have set?
Following the completion of the first cycle, it is recommended that practices complete the first part of the
Audit of Medical Practice (CQI activity) Summary Sheet (Appendix 1).
Undertaking a second cycle
In addition to regular reviews of progress with the practice team, a second audit cycle should be completed in order
to quantify progress on closing the gaps in performance.
It is recommended that the second cycle be completed within 12 months of completing the first cycle. The second cycle
should begin at the data collection stage. Following the completion of the second cycle it is recommended practices complete
the remainder of the Audit
of Medical Practice (CQI activity) Summary Sheet.
Claiming credits for Te Whanake CPD programme requirements
Practice or clinical audits are useful tools for improving clinical practice and credits can be claimed towards the Patient Outcomes (Improving Patient Care and Health Outcomes) learning category of the Te Whanake CPD programme, on a credit per learning hour basis. A minimum of 12 credits is required in the Patient Outcomes category over a triennium (three years).
Any data driven activity that assesses the outcomes and quality of general practice work can be used to gain credits in the Patient Outcomes learning category. Under the refreshed Te Whanake CPD programme, audits are not compulsory and the RNZCGP also no longer requires that clinical audits are approved prior to use. The college recommends the PDSA format for developing and checking the relevance of a clinical audit.
To claim points go to the RNZCGP website: www.rnzcgp.org.nz
If a clinical audit is completed as part of Te Whanake requirements, the RNZCGP continues to encourage that evidence of participation in the audit be attached to your recorded activity. Evidence can include:
- A summary of the data collected
- An Audit of Medical Practice (CQI) Activity summary sheet (Appendix 1 in this audit or available on the
RNZCGP website).
N.B. Audits can also be completed by other health professionals working in primary care (particularly prescribers), if relevant. Check with your accrediting authority as to documentation requirements.