zopiclone: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
zopiclone: clinical details
Prescribing considerations
- Identify and address underlying causes of insomnia.
- Assess substance misuse, psychiatric history and all prescribed, non-prescribed, herbal and online medicines.
- Consider dependence, falls, cognitive impairment and next-day psychomotor impairment, particularly in older or frail people.
- Avoid alcohol and carefully assess combinations with opioids or other central nervous system depressants.
- Assess depression and suicide risk; zopiclone does not treat depression.
- Not licensed for people under 18 years because safety and efficacy are not established.
Contraindications and cautions
- Hypersensitivity to zopiclone or a listed excipient.
- Severe hepatic insufficiency.
- Sleep apnoea syndrome.
- Myasthenia gravis.
- Severe respiratory insufficiency.
- Previous complex sleep behaviour after taking zopiclone.
Monitoring
- Review therapeutic need and response regularly.
- Monitor for escalating use, early-supply requests, tolerance, misuse, dependence and withdrawal.
- Assess next-day sedation, cognition, coordination, falls and driving or occupational safety.
- Monitor for respiratory depression and excessive sedation with opioids or other central nervous system depressants.
- Review agitation, aggression, hallucinations, complex sleep behaviour, worsening depression or suicidal thinking.
Clinical pharmacology
A cyclopyrrolone, benzodiazepine-related hypnotic acting at the GABA-A receptor complex. Oral bioavailability is about 80%, with peak plasma concentrations within roughly 1.5–2 hours. It undergoes extensive hepatic metabolism, including CYP3A4-mediated pathways. Its elimination half-life is prolonged in older people and hepatic impairment.
Formulation and product differences
- The selected Grindeks film-coated tablet is white, round, biconvex, plain on both sides and approximately 5 mm in diameter.
- The selected formulation is essentially sodium-free and its listed excipients do not include lactose.
- The selected tablet is not described as scored; appearance, excipients and divisibility can differ between products.
zopiclone preparations and strengths
zopiclone interactions
Zopiclone has additive sedative effects and is affected by medicines that alter CYP3A4 activity.
Alcohol
Can markedly increase sedation, impaired coordination, breathing problems and difficulty waking; avoid alcohol.
Opioids, including codeine, morphine and oxycodone
Can cause profound sedation, respiratory depression, coma or death.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.