Non-benzodiazepine hypnotic (Z-drug; cyclopyrrolone S-isomer of zopiclone) Pregnancy: §4.6 — There are no or limited data from use in pregnant women; animal studies have shown reproductive toxicity and the potential risk for humans is unknown. Eszopiclone is not recommended during pregnancy or in women of childbearing potential not using contraception. When racemic zopiclone is taken during the later stages of pregnancy, withdrawal symptoms may occur postnatally in the newborn; during the last trimester there is a risk of adverse pharmacological effects on the foetus and/or neonate such as hypotonia, respiratory depression and hypothermia. Breast-feeding: transfer of racemic zopiclone into breast milk has been demonstrated; a risk to the suckling child cannot be excluded and eszopiclone should not be used during breast feeding.

Eszopiclone

Brand names: Lunesta (US)

Eszopiclone is a non-benzodiazepine (Z-drug) hypnotic used for the short-term treatment 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: Starting dose 1 mg; the dose can be increased to 2 mg or 3 mg if clinically indicated

Route: Oral (tablets must not be crushed or broken prior to ingestion)

Frequency: Once daily, taken as a single intake immediately at bedtime; must not be re-administered during the same night

Max: 3 mg — the total dose of eszopiclone should not exceed 3 mg. The lowest effective dose should be used

Source: UK SPC (eMC) for Lunivia 1 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/100418/smpc). DURATION: treatment should be given for the shortest possible duration — typically no more than four weeks including the period of tapering off. In certain cases, for example patients with chronic insomnia, it may be necessary to extend treatment up to a maximum duration of 6 months, which requires regular monitoring and evaluation since the risk of abuse and dependence increases with the duration of treatment. Prior to starting treatment a discussion should be held with the patient to put in place a strategy for ending treatment, to minimise the risk of dependence, addiction and drug withdrawal syndrome. POTENT CYP3A4 INHIBITORS: in elderly patients (>65 years) receiving concomitant potent CYP3A4 inhibitors, eszopiclone is CONTRAINDICATED; in other adult patients the dose must not exceed 2 mg. CNS DEPRESSANTS: a dose reduction may be necessary when co-administered with other CNS depressants because of potentially additive effects. ELDERLY (65 or older): recommended starting dose 1 mg immediately before bedtime, which may be increased to 2 mg if clinically indicated; the recommended dose must not be exceeded. HEPATIC IMPAIRMENT: no dose adjustment in mild to moderate impairment; contraindicated in severe hepatic insufficiency as it may precipitate encephalopathy. PAEDIATRIC: §4.2 states eszopiclone should not be used in children and adolescents less than 18 years and that safety and efficacy have not been established; §4.3 contraindicates use in children and adolescents under 18 years of age — no paediatric dose is given. Verify any under-18 use against a children's formulary. OPIOIDS (§4.4): concomitant use may result in sedation, respiratory depression, coma and death — reserve for patients with no alternative, use the lowest effective dose for the shortest time and monitor closely. RESPIRATORY (§4.4): a lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression (no figure is given). The eMC §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved — the interactions below are drawn from the retrieved §4.2/§4.3/§4.4 and the US label in this bundle.

Dose adjustments

Renal

§4.2 — No dose adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 2 mg.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, to zopiclone or to any of the excipients
Myasthenia gravis
Severe respiratory insufficiency
Severe sleep apnoea syndrome
Severe hepatic insufficiency
Patients who have experienced complex sleep behaviours after taking eszopiclone, zopiclone or any other hypnotic agents
Elderly patients receiving concomitant potent CYP3A4 inhibitors
Children and adolescents under 18 years of age

Side effects

Dysgeusia (unpleasant taste) — very common and the most commonly reported adverse reaction
Nervous system (common): headache, somnolence, dizziness, abnormal dreams, memory impairment, abnormal thinking; uncommon — vertigo, ataxia, abnormal gait, incoordination, hypokinesia, paraesthesia, stupor, tremor
Psychiatric (common): nervousness, depression, anxiety; uncommon — emotional lability, decreased libido, confusion, agitation, hallucinations, insomnia, apathy, euphoria; rare — irritability, aggression, restlessness, delusion, anger, abnormal behaviour (possibly associated with amnesia) and somnambulism; not known — drug dependence and withdrawal syndrome
Gastrointestinal (common): dry mouth, diarrhoea, nausea, dyspepsia, abdominal pain, vomiting
Common: rash, migraine, pharyngitis, blurred vision (predominantly in elderly patients)
Rare/not known: angiooedema and anaphylactic reaction; respiratory depression; very rare — mild to moderate increased transaminases and/or blood alkaline phosphatase

Interactions

Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) — increase eszopiclone exposure; contraindicated in elderly patients over 65 years and the dose must not exceed 2 mg in other adults (§4.2, §4.3; US label §7.2)
CYP3A4 inducers (rifampicin) — combination use may decrease exposure and the effect of eszopiclone (US label §7.2)
Opioids — sedation, respiratory depression, coma and death; use the lowest effective dose for the shortest duration and monitor closely (§4.4)
Other CNS depressants — potentially additive effects; a dose reduction for eszopiclone may be necessary (§4.2, §4.5 cross-reference)
Ethanol — additive effect on psychomotor performance (US label §7.1)
Olanzapine — coadministration produced a decrease in DSST scores (pharmacodynamic interaction, no pharmacokinetic alteration) (US label §7.1). NOTE: the UK SPC §4.5 was not retrieved in this bundle.

Clinical monograph

How it works

It acts at the benzodiazepine site of the GABA-A receptor to enhance GABA-mediated inhibition, producing sedative and hypnotic effects.

Prescribing in practice

Like other hypnotics, it carries a risk of dependence, tolerance and next-day impairment, so use should be limited to the shortest effective period.
Combination with alcohol, opioids or other CNS depressants increases sedation and respiratory depression risk.
Complex sleep behaviours such as sleep-walking and sleep-driving have been reported with Z-drugs and warrant discontinuation if they occur.

Monitoring

Monitor for next-day sedation, dependence and any complex sleep behaviours during treatment.

Counselling the patient

Take only when you can have a full night's sleep and avoid alcohol.
May impair driving the next morning.
Use for the shortest time possible and do not stop abruptly after prolonged use.

Evidence & guidelines

Z-drugs are recommended only for short-term insomnia, consistent with NICE guidance on hypnotic use.

Reference: NICE CKS Insomnia; DVLA guidance; 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

Pathways