Non-Benzodiazepine Hypnotic (Z-Drug) Pregnancy: §4.6: The use of zopiclone is NOT RECOMMENDED during pregnancy. Zopiclone crosses the placenta. A large amount of data on pregnant women (more than 1000 pregnancy outcomes) has not demonstrated evidence of malformations following first-trimester exposure to benzodiazepines or benzodiazepine-like substances, although certain case-control studies reported an increased incidence of cleft lip and palate. Reduced fetal movement and fetal heart-rate variability have been described after second and/or third trimester administration. Administration in late pregnancy or during labour has been associated with hypothermia, hypotonia, feeding difficulties ('floppy infant syndrome') and respiratory depression in the neonate, with cases of severe neonatal respiratory depression reported; infants of mothers taking sedative/hypnotics chronically in late pregnancy may develop physical dependence and neonatal withdrawal. Appropriate monitoring of the newborn in the postnatal period is recommended. Breast-feeding: zopiclone is excreted in breast milk and use in nursing mothers MUST BE AVOIDED.

Zopiclone

Brand names: Zimovane

Zopiclone is a short-acting cyclopyrrolone hypnotic used for the short-term management of insomnia.

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: 7.5 mg (one tablet) shortly before retiring

Route: Oral (tablet swallowed without sucking or chewing)

Frequency: Once nightly, taken as a single intake just before retiring for the night; must NOT be re-administered during the same night

Source: UK SPC (eMC) for Zimovane 7.5mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/2855/smpc). Use the lowest effective dose. NO SEPARATE NUMERIC MAXIMUM DOSE is stated in §4.2 beyond the recommended adult dose of one 7.5 mg tablet, so the maxDose field is omitted — clinician to confirm. DURATION: as with all hypnotics, long-term use is not recommended; 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 should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with the duration of treatment. Prior to starting treatment a discussion should be held with patients to explain the risk of dependence, addiction and drug withdrawal syndrome, and to put in place a strategy for ending treatment. ELDERLY: 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. HEPATIC INSUFFICIENCY: as elimination may be reduced, a lower dose of 3.75 mg nightly is recommended; the standard 7.5 mg dose may be used with caution in some cases depending on effectiveness and acceptability. Severe hepatic insufficiency is a contraindication. CHRONIC RESPIRATORY INSUFFICIENCY: a starting dose of 3.75 mg is recommended initially, and the dosage may subsequently be increased to 7.5 mg. PAEDIATRIC: zopiclone should NOT be used in children and adolescents less than 18 years — safety and efficacy in this group have not been established, and §4.3 states that as with all hypnotics Zimovane should not be used in children. Hence paedDose is null. Verify any under-18 use against a children's formulary. METHOD OF ADMINISTRATION: for oral use only. NOTE ON SOURCE COVERAGE: this bundle contains the UK SPC only — no US (openFDA) label was retrieved, and §4.5 Interactions was not fetched, so no interactions list is provided here. The clinician must review §4.5 of the SPC separately; §4.4 does flag that hypnotics have the capacity to depress respiratory drive and that risks of dependence are increased in individuals with current or past substance misuse disorder (including alcohol misuse) or mental health disorder.

Dose adjustments

Renal

Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency. However, it is recommended that patients with impaired renal function should start treatment with 3.75 mg (§4.2).

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
Patients who have previously experienced complex sleep behaviours after taking zopiclone
As with all hypnotics, should not be used in children

Side effects

Dysgeusia — bitter taste (common)
Somnolence, residual (common)
Dry mouth (common); nausea and vomiting (uncommon)
Dizziness and headache (uncommon); anterograde amnesia (rare); fatigue (uncommon)
Nightmare and agitation (uncommon); confusional state, irritability, aggression, hallucination (rare); complex sleep behaviours including somnambulism, drug dependence and withdrawal syndrome (not known)
Respiratory depression (not known); dyspnoea (rare); fall, predominantly in elderly patients (rare)

Clinical monograph

How it works

It enhances GABAergic inhibitory transmission by acting at the benzodiazepine binding site of the GABA-A receptor complex.

Prescribing in practice

Tolerance and dependence can develop, so it should be limited to short-term use at the lowest effective dose.
Next-day drowsiness can impair driving and skilled tasks, particularly in older people who are also more prone to falls.
A characteristic bitter or metallic taste is common and may affect adherence.

Monitoring

Review continued need regularly and monitor for dependence, daytime sedation and falls risk in older patients.

Counselling the patient

You may notice a bitter or metallic taste, which is harmless.
Avoid alcohol and do not drive if you feel drowsy the next day.
Use it for as short a time as possible to avoid becoming dependent.

Evidence & guidelines

NICE advises that hypnotics such as Z-drugs be used only for severe insomnia and for the shortest period possible.

Reference: NICE NG215 Insomnia; MHRA Drug Safety Update 2022; 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

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