ZOPICLONE — 3.75 mg / 7.5 mg tablets
📦 Product Snapshot
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🧠 Overview
Zopiclone is a non‑benzodiazepine hypnotic agent from the cyclopyrrolone class, used for the short‑term management of insomnia in adults. It was introduced in the 1980s and is available in over 100 countries. While structurally unrelated to benzodiazepines, it exerts its effects by binding to the GABAA receptor at a site distinct from benzodiazepines, enhancing the action of the inhibitory neurotransmitter GABA and producing sedative, hypnotic, and anxiolytic effects.
Onset and duration: Zopiclone is rapidly absorbed, with peak plasma concentrations occurring within 1–2 hours and an elimination half‑life of approximately 5–6 hours. It reduces sleep latency, decreases nocturnal awakenings, and increases total sleep time. The standard adult dose is 7.5 mg taken immediately before bedtime, with at least 7–8 hours of sleep remaining.
Critical limitation – short‑term use: Zopiclone is indicated for short‑term use only, typically 2–4 weeks. Tolerance to the hypnotic effect may develop after repeated use, and prolonged use is associated with dependence, abuse, and withdrawal symptoms upon discontinuation. It is not recommended for chronic insomnia.
Note on eszopiclone (Lunesta®): In the United States, zopiclone itself is not FDA‑approved. Instead, its active stereoisomer, eszopiclone, is available as a schedule IV controlled substance. Eszopiclone has similar pharmacology but different dosing (1 mg, 2 mg, 3 mg).
🏷️ Strengths & Brand Examples
- 3.75 mg tablets (low‑strength, often for elderly or hepatic/renal impairment)
- 7.5 mg tablets (standard adult dose)
- Oral solution (5 mg/5 mL) available in some countries for patients with swallowing difficulties
- Zimovane® 7.5 mg (original UK brand)
- Zimovane LS® 3.75 mg (low strength)
- Imovane® (France, Canada, Australia)
- Sliprex Fast® 7.5 mg (Taj Life Sciences / Taj Pharma) — manufactured in USFDA, EU-GMP, PICs approved facilities [
- Zolfresh® 7.5 mg (Sun Pharma)
- Zopicon® 7.5 mg (Cipla)
- Zopiwin® 7.5 mg (Win-Medicare)
- Zodorm® 7.5 mg (Abbott)
- Numerous generic versions from Zydus, Alkem, Intas, Torrent, Mankind, etc.
- Lunesta® 1 mg, 2 mg, 3 mg (brand and generic) — Schedule C‑IV
⚠️ Safety, Side Effects & Monitoring
- Bitter or metallic taste (dysgeusia) — very characteristic, up to 30%
- Drowsiness / somnolence (next‑day)
- Dry mouth
- Dizziness, headache
- Nausea, vomiting, gastrointestinal upset
- Coordination problems, ataxia (especially in elderly)
- Nightmares, abnormal dreams
• Next‑day impairment: Can impair driving, operating machinery even when feeling fully awake. Risk increased with doses >7.5 mg, <7–8 h sleep, or with other CNS depressants.
• Dependence and tolerance: Physical and psychological dependence may develop after >4 weeks use. Abrupt withdrawal causes rebound insomnia, anxiety, restlessness, confusion, palpitations, sweating, nightmares, hallucinations, seizures (rare).
• Withdrawal symptoms: Include anxiety, shaking, irritability, agitation, confusion, panic attacks, sweating, headache, faster heartbeat, sensitivity to light/noise/touch, numbness/tingling, muscle aches, seizures (rare).
• CNS depression: Additive effects with alcohol, opioids, benzodiazepines, tricyclic antidepressants, antipsychotics, antihistamines. May cause severe sedation, respiratory depression, coma, death.
• Anaphylaxis / angioedema: Rare but serious — discontinue immediately if swelling of face, lips, tongue, throat occurs.
• Worsening of depression / suicidality: Monitor patients with depression; prescribe minimal quantity to reduce overdose risk.
- Hypersensitivity to zopiclone or any excipient
- Myasthenia gravis (severe muscle weakness)
- Respiratory failure (severe COPD, sleep apnoea)
- Severe hepatic impairment (Child‑Pugh C)
- Age <18 years (safety not established)
- History of complex sleep behaviors after taking zopiclone
- Elderly (>65 years): Start with 3.75 mg (half tablet). Increased risk of falls, cognitive impairment, next‑day sedation. Max dose 3.75–7.5 mg based on response.
- Hepatic impairment: Mild‑moderate: consider 3.75 mg. Severe: contraindicated (exposure doubled).
- Renal impairment: No dose adjustment needed (<10% excreted unchanged), but caution.
- Pregnancy: Avoid — limited safety data; crosses placenta. Neonatal withdrawal reported with long‑term use.
- Breastfeeding: Zopiclone excreted in milk — avoid or use with caution; monitor infant for sedation.
- Alcohol, opioids, benzodiazepines, barbiturates, gabapentinoids, antipsychotics, TCAs, antihistamines: Additive CNS depression — respiratory depression, coma, death. Avoid.
- CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir): Increase zopiclone levels — may need dose reduction.
- CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John’s wort): Decrease zopiclone efficacy — may need dose increase.
- Caffeine: Opposite effect — reduces hypnotic efficacy. Avoid before bedtime.
- Symptoms: Drowsiness, confusion, ataxia, depressed reflexes, coma, respiratory depression, hypotension, death (especially with co‑ingestants).
- Management: Supportive care, monitoring of vital signs, flumazenil may reverse CNS depression (but not always recommended). Activated charcoal if recent ingestion.