Licensed use: short-term insomnia
Zopiclone is licensed in the UK for the short-term treatment of insomnia in adults. The licence covers insomnia characterised by:
- Difficulty falling asleep (sleep onset insomnia)
- Frequent night-time waking (sleep maintenance insomnia)
- Early morning waking
- Insomnia causing significant daytime impairment
NICE guidance and treatment pathway
NICE guidance recommends that insomnia should first be managed through:
- Sleep hygiene education
- Cognitive Behavioural Therapy for Insomnia (CBT-I) — the most effective long-term treatment
- Relaxation techniques and stimulus control therapy
Zopiclone is considered only when these approaches have been tried or are not accessible, and symptoms are severe enough to impair daily functioning.
Why treatment must be short-term
Tolerance to zopiclone's sleep-promoting effects can develop within days to weeks of regular use. Physical dependence — characterised by rebound insomnia and withdrawal symptoms when stopping — can occur after as little as 3–4 weeks of nightly use. For this reason, the BNF recommends treatment be limited to 2 to 4 weeks maximum.
When zopiclone is not appropriate
- Children and young people under 18
- People with sleep apnoea or respiratory depression
- Severe liver disease
- Myasthenia gravis
- People with a history of substance dependence
- Pregnancy or breastfeeding (see pregnancy guide)