Appropriate use of zopiclone and benzodiazepines for the treatment of insomnia

Zopiclone and some benzodiazepines, such as temazepam and triazolam, are indicated for the short-term treatment of insomnia. However, pharmacological treatment is not first-line for either of these conditions and long-term use of these medicines should be avoided where possible due to adverse effects and the potential for dependence. This audit aims to promote appropriate use of these medicines, particularly for those who are taking these medicines long-term. Advice about the risks and adverse effects and guidance on withdrawal should be given to all patients who are prescribed these medicines.

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Published: 17 December 2020

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Zopiclone and 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. This can lead to adverse clinical outcomes, such as an increased risk of falls and motor vehicle accidents, particularly in older or frail people. 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 non-pharmacological interventions to improve sleep have been unsuccessful, zopiclone or a short-acting benzodiazepine (i.e. temazepam [fully funded] or triazolam [partly funded]) may be tried, prescribed at the lowest effective dose for a short duration, e.g. preferably five to ten days, but can be used for up to four weeks. Prior to starting the medicine, patients should be given information about the risks and benefits of treatment, including adverse effects and the potential for dependence; ensure they understand that these medicines are intended for short-term use only (i.e. not taken on a regular basis) and non-pharmacological strategies should be continued alongside. There are no clear clinical guidelines regarding the appropriate medicine-free interval between short courses of hypnotics.

Stopping benzodiazepine or zopiclone treatment in people who have been taking these medicines long term can be challenging. Strategies to encourage patients to stop a benzodiazepine or zopiclone should involve education to realign their perceptions of risks and benefits, non-pharmacological approaches to manage insomnia or anxiety, and gradual tapering of the dose.

N.B. Rapid withdrawal of benzodiazepines is associated with an increased risk of seizures, therefore patients who have been taking these medicines long-term should be counselled against stopping their use abruptly.

For further information on benzodiazepine and zopiclone withdrawal strategies, see: www.bpac.org.nz/bpj-e/one

For further information on managing insomnia, see: www.bpac.org.nz/2017/insomnia-1.aspx and www.bpac.org.nz/2017/insomnia-2.aspx

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.

Summary

This audit identifies patients who are currently taking zopiclone or a short-acting benzodiazepine (temazepam or triazolam are used principally for the treatment of insomnia) to promote appropriate use of these medicines, particularly for those who are using these medicines long-term. Advice about the risks and adverse effects and guidance on withdrawal should be given to all patients who are prescribed these medicines.

Recommended audit standards

Ideally, the risks and benefits of treatment will have been discussed with all patients who are prescribed zopiclone, temazepam or triazolam and the conversation documented in the notes. 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.

Identifying eligible patients

All patients within the practice who have had a prescription of zopiclone, temazepam or triazolam in the past 12 months are eligible for this audit.

You will need to have a system in place that allows you to identify eligible patients. Many practices will be able to identify patients by running a ‘query’ through their PMS and then reviewing the clinical notes.

N.B. Zopiclone is likely to be the most frequently prescribed hypnotic, but the audit should include temazepam and triazolam as these are the benzodiazepines primarily used for the treatment of insomnia.

Sample size

The number of eligible patients will vary according to your practice demographic. If a large number of results are returned, a sample size of 20–30 patients is sufficient for this audit. However, all eligible patients will need to be reviewed subsequently.

Criteria for a positive result

For a positive result for the audit, the patient’s clinical notes should contain documentation of discussions about:

  • The risks and adverse effects of these medicines, including the potential for dependence
  • Alternative methods to manage insomnia
  • An agreed duration of use and/or a discussion about how to discontinue the medicine

N.B. These discussions may have taken place over different consultations.

Any patient whose notes do not contain the information described above should be flagged for review.

Data analysis

Use the data sheet provided to record your data. A positive result is any patient who has evidence in their notes of discussions of the risks and adverse effects of these medicines, alternative methods to manage their insomnia and duration of use and/or discontinuing the medicine. The percentage achievement can be calculated by dividing the number of patients with a positive result by the total number of patients audited.

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 wdealing 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 behaviour

Monitoring change and progress

It is important to review the action plan developed previously at regular intervals. It may be helpful to review 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 practitioners complete the first part of the 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 that practices complete the remainder of the Audit of Medical Practice summary sheet.

Claiming credits for Continuing Professional Development (CPD)

This audit has been endorsed by The Royal New Zealand College of General Practitioners (RNZCGP) and has been approved for 10 CME credits for a first cycle and 10 CME credits for a second cycle for the General Practice Educational Programme (GPEP) and Continuing Professional Development (CPD) purposes. The second cycle is optional and only two cycles are permissible.

To claim points go to the RNZCGP website: www.rnzcgp.org.nz

Record your completion of the audit on the CPD Online Dashboard, under the Audit of Medical Practice section. From the drop down menu select “Approved practice/PHO audit” and record the audit name.

General practitioners are encouraged to discuss the outcomes of the audit with their peer group or practice.

As the RNZCGP frequently audit claims you should retain the following documentation, in order to provide adequate evidence of participation in this audit:

  1. A summary of the data collected
  2. An Audit of Medical Practice (CQI) Activity summary sheet (included as Appendix 1).
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