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Non-Benzodiazepine Hypnotic (Z-Drug) Pregnancy: Avoid — neonatal withdrawal syndrome and respiratory depression

Zopiclone

Brand names: Zimovane

Adult dose

Dose: 7.5 mg taken immediately before bedtime. Elderly: 3.75 mg OD initially.
Route: Oral
Frequency: Once at bedtime
Max: 7.5 mg nightly
Short-term insomnia (2–4 weeks maximum). Not for long-term use — tolerance, dependence, and rebound insomnia. Class C controlled drug. Bitter taste (zinc supplement may help). Driving: advise not to drive next morning until effects have worn off.

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not licensed in children
Not recommended in paediatric patients

Dose adjustments

Renal

No dose adjustment required; caution in severe renal impairment

Hepatic

Start at 3.75 mg in hepatic impairment — reduced metabolism

Clinical pearls

  • MHRA 2022: complex sleep behaviours (sleep-driving, sleep-eating) reported — stop if this occurs; inform patient before prescribing
  • Maximum 2–4 weeks: if used longer, advise taper to prevent rebound insomnia and dependence
  • Class C controlled drug (Schedule 4) — since 2014; FP10 prescription required
  • Address sleep hygiene and CBT-I (cognitive behavioural therapy for insomnia) as preferred long-term strategies

Contraindications

  • Respiratory failure
  • Sleep apnoea
  • Myasthenia gravis
  • Severe hepatic impairment
  • History of drug dependence

Side effects

  • Bitter metallic taste (very common)
  • Morning hangover/drowsiness
  • Dependence with regular use >2 weeks
  • Rebound insomnia on stopping
  • Complex sleep behaviours (sleepwalking, sleep-eating) — MHRA 2022 warning
  • Paradoxical excitation (elderly)

Interactions

  • CNS depressants — additive sedation and respiratory depression
  • Alcohol — additive (contraindicated — dangerous combination)
  • Erythromycin/clarithromycin — increase zopiclone levels

Monitoring

  • Sleep diary assessment
  • Signs of dependence or escalating dose
  • Complex sleep behaviours
  • Morning functioning

Reference: BNFc; BNF; NICE NG215 Insomnia; MHRA Drug Safety Update 2022. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.