Published: 7 June 2019

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Zopiclone – Indicated for short-term use only

Prescriber Update 40(2): 32
June 2019

Zopiclone should be used at the lowest effective dose and only for short periods

Zopiclone is indicated for the short-term treatment of insomnia in adults¹. The approved adult dose is 7.5 mg taken shortly before bedtime for up to a maximum of 4 weeks. Medsafe has not assessed the safety and efficacy of longer-term use. Use of zopiclone for longer than 4 weeks should be considered ‘off-label’.

If zopiclone is needed to manage insomnia, it should be used in conjunction with non-pharmacological approaches, such as managing expectations about sleep duration, improving sleep hygiene, modifying lifestyle factors, and addressing underlying health issues and psychological stress^2–4.

Long term use of zopiclone may cause tolerance and dependence, leading to withdrawal and rebound insomnia if the medicine is stopped abruptly. A gradual reduction in dose and/or frequency of use can reduce the likelihood of withdrawal effects after long-term use^1–3.

Zopiclone is eliminated via hepatic metabolism, therefore, hepatic impairment increases the risk of adverse effects. In healthy adults, the elimination half-life of zopiclone after a single dose is 5 hours. In patients with hepatic failure, the elimination half-life is prolonged to nearly 12 hours¹.

Risk of adverse effects greater in the elderly

The recommended dose for elderly patients is 3.75 mg. The dose may be increased if the lower dose is not effective, but a higher dose is more likely to cause central nervous system side effects in the elderly¹.

In elderly patients, the elimination half-life of zopiclone is prolonged to approximately 7 hours, compared to 5 hours in younger adults. The risk of next-day ‘hangover’ effects such as drowsiness, cognitive impairment and dizziness is, therefore, higher in the elderly. These ‘hangover’ effects put elderly patients at greater risk of falls, and may also affect their ability to drive.

Psychiatric adverse events, including depression, suicidality, psychosis and schizophrenia, have been associated with the use of zopiclone. Psychiatric adverse reactions and paradoxical effects such as restlessness, irritability and aggression are more likely to occur in the elderly¹.

References

1. Sanofi-Aventis New Zealand Ltd. 2018. Imovane 7.5 mg film coated tablet New Zealand Data Sheet 28 March 2018. URL: https://medsafe.govt.nz/profs/Datasheet/i/Imovanetab.pdf (accessed 16 April 2019).
2. BPAC NZ. 2017. I dream of sleep: Managing insomnia in adults. Part 1: Diagnosis and non-pharmacological treatment. Best Practice Journal October 2017. URL: https://bpac.org.nz/2017/insomnia-1.aspx (accessed 16 April 2019).
3. BPAC NZ. 2017. I dream of sleep: Managing insomnia in adults. Part 2: The ideal pharmacological approach for improving sleep. Best Practice Journal October 2017. URL: https://bpac.org.nz/2017/insomnia-2.aspx (accessed 16 April 2019).
4. Winkelman JW. 2015. Insomnia disorder. New England Journal of Medicine 373(15): 1437-44. URL: https://www.nejm.org/doi/full/10.1056/NEJMcp1412740 (accessed 16 April 2019).