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Non-Benzodiazepine Hypnotic (Z-drug) Pregnancy: Avoid in pregnancy; neonatal withdrawal possible

Zopiclone

Brand names: Zimovane

Adult dose

Dose: 7.5 mg at bedtime
Route: Oral
Frequency: Once nightly (short-term only)
Max: 7.5 mg/night
For short-term insomnia only — maximum 4 weeks

Paediatric dose

Dose: Not recommended N/A/kg
Route: Oral
Frequency: Not recommended
Max: Not recommended
Not licensed and not recommended in children

Dose adjustments

Renal

No dose adjustment, but use with caution

Hepatic

Reduce to 3.75 mg in moderate-severe hepatic impairment

Paediatric weight-based calculator

Not licensed and not recommended in children

Clinical pearls

  • Beers Criteria 2023 and STOPP v3: Z-drugs are potentially inappropriate in elderly — increased risk of falls, fractures, motor vehicle accidents, and cognitive impairment; NOT safer than benzodiazepines despite common perception
  • In elderly, reduce to 3.75 mg — halved dose recommended per BNF due to increased sensitivity
  • NICE CG49 (Insomnia): CBT-I (cognitive behavioural therapy for insomnia) is first-line; hypnotics for short-term only after non-pharmacological measures have failed
  • Dependence risk similar to benzodiazepines — avoid prescribing for more than 4 weeks; taper on withdrawal
  • Bitter taste is a characteristic and common complaint — warn patients

Contraindications

  • Severe respiratory failure
  • Severe hepatic impairment
  • Myasthenia gravis
  • Sleep apnoea

Side effects

  • Bitter metallic taste (characteristic)
  • Daytime sedation and hangover
  • Cognitive impairment
  • Falls and fractures
  • Dependence and tolerance
  • Rebound insomnia on withdrawal
  • Parasomnias (sleepwalking, sleep-eating)

Interactions

  • CNS depressants (additive sedation)
  • Erythromycin / clarithromycin (CYP3A4 inhibitors — increase levels)
  • Rifampicin (reduces efficacy)

Monitoring

  • Daytime sedation
  • Falls risk assessment
  • Duration of use (4-week maximum)
  • Withdrawal symptoms on stopping

Reference: BNFc; BNF 90; NICE CG49 (Insomnia); AGS Beers Criteria 2023; STOPP/START v3. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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