Zopiclone

Pronunciation: pronunciation varies by local usage.

Generic name: zopiclone
Brand names: Zimovane
Drug class: Non-benzodiazepine hypnotic (Z-drug)
Form: Film-coated tablet
Route: Oral
Legal status: Prescription-only medicine

Availability and supply rules vary by country

Trade names by country: Canada

What zopiclone is and how it works

Zopiclone is a non-benzodiazepine hypnotic (Z-drug) used for the short-term treatment of insomnia in adults, including difficulty falling asleep, night-time awakening, and early awakening, when the insomnia is debilitating or causing severe distress. Long-term continuous use is not recommended. (1)

A prescriber must determine eligibility and specify the exact dose and duration. Treatment is kept as short as possible, usually 2–5 days for transient insomnia and up to 2–3 weeks for short-term insomnia, with a maximum of 4 weeks including tapering-off. Zopiclone is not for children or adolescents under 18.

Mechanism of action: how zopiclone works

Zopiclone is a non-benzodiazepine hypnotic (Z-drug). Detailed pharmacodynamic and pharmacokinetic data are available in the Summary of Product Characteristics. (1)

What zopiclone is used for

Short-term treatment of insomnia

Zopiclone is indicated for the short-term treatment of insomnia in adults when the condition is debilitating or causing severe distress. It may be used for difficulty falling asleep, night-time awakening, or early awakening, in transient, situational, or chronic insomnia. Continuous long-term use is not recommended; treatment duration is kept as short as possible (typically 2–5 days for transient insomnia, up to 2–3 weeks for short-term insomnia, and not exceeding 4 weeks including tapering). (1)

Before taking zopiclone

Do not take / not appropriate for

Do not take zopiclone if you have a known hypersensitivity to zopiclone or any of its ingredients. (all products) (1)
Do not take zopiclone if you have myasthenia gravis, respiratory failure, severe sleep apnoea syndrome, or severe hepatic insufficiency. (all indications) (1)
Do not take zopiclone if you are under 18 years of age. (all indications) (1)

Tell your clinician about

Any history of dependence or abuse of substances, including prescription medicines or alcohol.
Any respiratory problems, kidney disease, liver disease, or other medical conditions.
Current use of any other medicines, especially opioids, other sedatives, or CYP3A4 inhibitors or inducers.
Pregnancy, planned pregnancy, or breastfeeding status.
History of complex sleep behaviours (e.g., sleep-walking) or psychiatric reactions with hypnotic medicines.
If you are elderly and at risk of falls.

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How to take zopiclone

Take zopiclone by mouth as a single dose shortly before bedtime, exactly as prescribed.
The usual adult dose is 7.5 mg; the prescriber may start at 3.75 mg for the elderly or those with kidney, liver, or respiratory impairment.
Do not exceed the prescribed dose or duration. Treatment is typically 2–5 days for transient insomnia, up to 2–3 weeks for short-term insomnia, and never more than 4 weeks including any taper-off period arranged by the prescriber.
Do not stop taking zopiclone abruptly after regular use; your prescriber will provide a gradual reduction plan.
Avoid driving or operating machinery for at least 12 hours after taking a dose because next-morning impairment can occur.

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Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)

Missed dose

No specific missed-dose advice is provided in the UK product information. Contact the prescriber or pharmacist for guidance. Do not take an extra tablet to make up for a missed dose.

Overdose

If you or someone else has taken more than the prescribed dose of zopiclone, especially if combined with alcohol or other medicines that cause drowsiness (e.g., opioids), seek emergency medical attention immediately. Overdose can cause severe drowsiness, confusion, respiratory depression, or coma. (1)

Side effects

Side effects are most likely at the start of treatment. The most characteristic effect is a bitter or metallic taste (dysgeusia).

Bitter or metallic taste (dysgeusia)

What to notice: A persistent unpleasant bitter or metallic taste in the mouth, often noticed upon waking.

What to do: Tell the prescriber if it becomes intolerable. It is a known effect and may improve with dose adjustment or discontinuation, but do not adjust the dose yourself. (1)

Dry mouth

What to notice: A sensation of a dry or sticky mouth.

What to do: Sipping water may help. Inform the prescriber if bothersome. (1)

Residual morning drowsiness

What to notice: Feeling groggy or sleepy the morning after taking zopiclone.

What to do: Avoid driving or operating machinery for at least 12 hours after a dose. If severe, contact the prescriber – a dose reduction may be needed, but do not adjust the dose yourself. (1)

Dizziness, headache, nausea, fatigue

What to notice: These uncommon effects may occur, especially early in treatment.

What to do: Inform the prescriber if they persist or worsen. (1)

Complex sleep-related behaviours

What to notice: Performing activities while asleep or not fully awake (e.g., sleep-walking, sleep-driving, preparing food), with no memory of the event.

What to do: Seek medical attention promptly; let the clinician you see advise on whether to continue or stop zopiclone. Do not drive or perform hazardous activities until evaluated. (1)

Withdrawal reactions after regular use

What to notice: Anxiety, tremor, sweating, rebound insomnia, and rarely hallucinations or seizures, typically after stopping abruptly.

What to do: Do not stop taking zopiclone abruptly. Contact the prescriber to arrange a gradual dose reduction. (1)

Psychiatric or paradoxical reactions

What to notice: Restlessness, agitation, irritability, aggression, confusion (more likely in the elderly).

What to do: Report these symptoms to the prescriber immediately. (1)

Next-morning impairment

What to notice: Drowsiness, dizziness, or reduced alertness the morning after a dose, which may affect driving or machine operation.

What to do: Do not drive or use machines for at least 12 hours after taking zopiclone. If impairment persists, contact the prescriber. (1)

Increased risk of falls

What to notice: Dizziness, unsteadiness, especially in the elderly.

What to do: Report any fall or unsteadiness to the prescriber. (1)

Serious warnings

Severe allergic reaction (hypersensitivity) — emergency

Symptoms: Rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Action: Seek emergency medical help immediately. Seek medical attention; the medical team decides on treatment. (1)

Complex sleep behaviours with potential for harm — emergency

Symptoms: Sleep-walking, sleep-driving, or performing other activities while not fully awake; no memory of the event.

Action: Seek urgent medical assessment. The prescriber will decide on continuing treatment. Do not drive or perform hazardous activities until evaluated. (1)

Severe withdrawal symptoms (e.g., seizures) — emergency

Symptoms: Confusion, hallucinations, or seizures after stopping zopiclone abruptly.

Action: Seek emergency medical help. The prescriber will arrange a supervised taper. (1)

Severe sedation, respiratory depression, or coma due to combined use with opioids or alcohol — emergency

Symptoms: Extreme drowsiness, confusion, slow or shallow breathing, loss of consciousness.

Action: Seek emergency medical help immediately. (1)

Interactions

Medicine or test	Effect	Action
CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir)	These medicines can increase zopiclone blood levels, leading to enhanced sedation and other side effects.	The prescriber may reduce the zopiclone dose if co-prescribed. Do not change the dose yourself. (1)
CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John’s wort)	These medicines can lower zopiclone blood levels, potentially reducing its effectiveness.	The prescriber may need to adjust the dose. Inform your prescriber of all medicines and herbal products you take. (1)
Opioids, other central nervous system depressants (e.g., benzodiazepines, antihistamines), and alcohol	Combined use can cause profound sedation, respiratory depression, coma, or death.	These combinations are used only when absolutely necessary, at the lowest possible doses, and under close medical supervision. Avoid alcohol entirely during zopiclone treatment. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Children and adolescents

Zopiclone is not recommended for anyone under 18 years of age. The prescriber must use alternative treatments in this age group. (1)

Pregnancy and breastfeeding

Zopiclone is not recommended during pregnancy. It is excreted in breast milk and should be avoided in nursing mothers. Discuss any risks with your prescriber; do not stop treatment without medical advice if you are already taking it. (1)

Elderly patients

The elderly are more sensitive to the effects of zopiclone and have an increased risk of falls. The starting dose is usually 3.75 mg. The prescriber will monitor closely. (1)

Patients with hepatic, renal, or respiratory impairment

Zopiclone is contraindicated in severe hepatic insufficiency. In less severe liver or kidney impairment, or in respiratory conditions, the starting dose is 3.75 mg, and extra caution is used. The prescriber decides whether zopiclone is appropriate. (1)

Monitoring

Before starting

Confirm the diagnosis of insomnia and that it is debilitating or causing severe distress, using the prescriber's clinical judgement.
Assess for contraindications: myasthenia gravis, respiratory failure, severe sleep apnoea, severe hepatic insufficiency, age under 18.
Screen for history of dependence, substance abuse, psychiatric illness, or complex sleep behaviours.
Review all concomitant medications, especially opioids, CNS depressants, and CYP3A4 inhibitors/inducers.
Discuss the maximum treatment duration (4 weeks including taper) and the importance of not stopping abruptly.
In elderly patients, assess fall risk and consider a starting dose of 3.75 mg.

During treatment

Re-evaluate the need for continued treatment at regular intervals, and do not exceed 4 weeks.
Monitor for side effects (dysgeusia, morning drowsiness, dizziness) and their impact.
Watch for signs of dependence, withdrawal, or abuse – record any requests for early refills.
Ask about complex sleep behaviours at every review; if reported, the prescriber will consider discontinuation.
Check for next-morning impairment and advise accordingly.
In the elderly, monitor mobility and falls.

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Storage

No special storage conditions are required. Keep the tablets in their original packaging, out of the sight and reach of children.

Study the drug class: Z-drugs and other hypnotics

Professional information

Clinician-facing context only. Use the current local product information and guidelines, including the SmPC for the specific zopiclone product.

United Kingdom

Indication: Short-term treatment of insomnia

Dose summary: Adults: 7.5 mg orally at bedtime. Elderly or patients with renal, hepatic, or respiratory impairment: start at 3.75 mg. Maximum duration 4 weeks (including taper). The prescriber determines the exact taper schedule.

Renal context: Use with caution; starting dose 3.75 mg. (1)

Mechanism of action

Hepatic guidance

Zopiclone is contraindicated in severe hepatic insufficiency. In less severe impairment, start at 3.75 mg and monitor closely.

Overdose note

Overdose requires immediate medical assessment, especially if co-ingestion with other CNS depressants is suspected. Monitor for sedation, respiratory depression, and coma. Supportive care and, where appropriate, flumazenil may be considered – refer to local protocols. (1)

Frequently asked questions

Why is zopiclone only prescribed for a maximum of 4 weeks?

Because dependence and tolerance can develop with prolonged use. Treatment is kept as short as possible – 2 to 5 days for transient insomnia and up to 2 to 3 weeks for other short-term insomnia, with a maximum of 4 weeks including any medicine-tapering period arranged by the prescriber. (1)

Why does my mouth taste bitter when I take zopiclone?

A bitter or metallic taste (called dysgeusia) is the most common side effect of zopiclone. It usually occurs shortly after taking the dose and may be noticed on waking. It is harmless but can be bothersome; tell your prescriber if it becomes intolerable. (1)

Can I drive the day after taking zopiclone?

You should not drive or operate machinery for at least 12 hours after taking a dose. Zopiclone can cause next-morning drowsiness or dizziness, which may impair your ability to drive safely. If you feel affected, wait longer and speak to your prescriber. (1)

How should I stop taking zopiclone?

After regular use, the prescriber will provide a gradual dose-reduction plan. Do not stop suddenly, as this can lead to withdrawal symptoms (anxiety, tremor, sweating, rebound insomnia, and rarely seizures). (1)

Is zopiclone available in the United States?

No; zopiclone is not FDA-approved in the US. The related medicine eszopiclone (Lunesta) is the US equivalent, but this page reflects the UK licence and product information. (1)

What is the mechanism of action of zopiclone?