Non-Benzodiazepine Hypnotic (Z-drug) Pregnancy: Use is not recommended during pregnancy; zopiclone crosses the placenta. Use in late pregnancy or during labour has been associated with neonatal hypothermia, hypotonia, feeding difficulties ('floppy infant syndrome') and respiratory depression, and with neonatal withdrawal after chronic maternal use. Zopiclone is excreted in breast milk - use in nursing mothers must be avoided.

Zopiclone

Brand names: Zimovane

Zopiclone is a short-acting cyclopyrrolone ("Z-drug") hypnotic used for the short-term treatment of insomnia; this page concerns its use in older people, in whom a reduced dose is appropriate.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Elderly patients: a lower dose of 3.75 mg should be employed to start treatment; depending on effectiveness and acceptability the dosage may subsequently be increased if clinically necessary. Standard adult dose: 7.5 mg (two 3.75 mg tablets or one 7.5 mg tablet) by the oral route shortly before retiring.

Route: Oral (swallow whole, without sucking, chewing or breaking)

Frequency: Once at night, just before retiring - taken as a single intake and not re-administered during the same night

Use the lowest effective dose. Treatment should be as short as possible and should not exceed four weeks including the period of tapering off; extension beyond the maximum treatment period requires re-evaluation because the risk of abuse and dependence increases with duration. Agree a strategy for ending treatment before starting. Hepatic insufficiency: a lower dose of 3.75 mg nightly is recommended (7.5 mg may be used with caution in some cases); contraindicated in severe hepatic insufficiency. Chronic respiratory insufficiency: start at 3.75 mg, may subsequently be increased to 7.5 mg. No maximum dose is stated in SPC 4.2 and no section 4.5 interaction text was captured in the fetched bundle. PAEDIATRIC: should not be used in children and adolescents less than 18 years - safety and efficacy not established.

Dose adjustments

Renal

Accumulation of zopiclone or its metabolites has not been seen in renal insufficiency; however, patients with impaired renal function should start treatment with 3.75 mg.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Myasthenia gravis
Respiratory failure
Severe sleep apnoea syndrome
Severe hepatic insufficiency
Hypersensitivity to zopiclone or to any of the excipients
Previous complex sleep behaviours after taking zopiclone
As with all hypnotics, should not be used in children

Side effects

Dysgeusia - bitter taste (common)
Residual somnolence (common)
Dry mouth (common)
Dizziness, headache, nausea, vomiting, fatigue, nightmare, agitation (uncommon)
Anterograde amnesia; falls, predominantly in elderly patients (rare)
Not known: complex sleep behaviours including somnambulism, respiratory depression, drug dependence and withdrawal syndrome

Clinical monograph

How it works

It enhances GABA-mediated inhibitory neurotransmission by binding at the benzodiazepine site of the GABA-A receptor, promoting sleep onset and continuity.

Prescribing in practice

In older patients the risk of daytime sedation, confusion, falls and fractures is markedly increased, so use the lowest effective dose for the shortest possible period and review the need promptly.
Tolerance and dependence develop with continued use, so prescribe for short courses only and avoid abrupt withdrawal after prolonged treatment.
Effects are potentiated by alcohol and other CNS depressants including opioids, and impairment may accumulate where hepatic or renal function is reduced.

Monitoring

No routine laboratory monitoring is required, but reassess sleep benefit, daytime functioning, falls risk and ongoing need at each review.

Counselling the patient

Take immediately before bed and only when a full night's sleep is possible, as it can cause next-day drowsiness.
Do not drink alcohol with this medicine and take care with driving or tasks needing alertness.
It is intended for short-term use only; speak to your prescriber before stopping if you have taken it regularly.

Evidence & guidelines

NICE guidance recommends Z-drugs only for short-term management of insomnia, and prescribing-safety advice emphasises lower doses and caution in older adults because of falls and confusion.

Reference: NICE CG49 (Insomnia); AGS Beers Criteria 2023; STOPP/START v3; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Pathways