Zopiclone 10mg

What Is Zopiclone?

Zopiclone is a prescription-only sleeping tablet used for the short-term treatment of insomnia in adults. It belongs to a group of medicines commonly called "Z-drugs" — a class that also includes zolpidem and zaleplon. Chemically, zopiclone is a cyclopyrrolone, which makes it structurally different from benzodiazepines such as diazepam or temazepam, even though the two groups act on the same receptor system and share many of the same risks.

In the United Kingdom, zopiclone is:

• A Prescription-Only Medicine (POM) — it cannot legally be sold over the counter or supplied without a valid prescription.
• A Class C controlled drug under the Misuse of Drugs Act 1971, and a Schedule 4 Part 1 substance under the Misuse of Drugs Regulations 2001. Possession without a prescription and supply to others are both criminal offences.
• Licensed at two strengths: 3.75mg and 7.5mg.

It is intended as a short, time-limited intervention — not as an ongoing treatment for chronic sleep problems. NICE guidance positions cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment for persistent insomnia, with hypnotic medicines reserved for severe, disabling episodes where the person is in significant distress.

How Does Zopiclone Work?

Zopiclone acts on the central nervous system by enhancing the effect of gamma-aminobutyric acid (GABA), the brain's principal inhibitory neurotransmitter.

The mechanism, step by step:

1. GABA is released by neurons and binds to GABA-A receptors on neighbouring cells.
2. Zopiclone binds to a modulatory site on that same receptor complex — the site benzodiazepines also occupy  — but with relative selectivity for receptors containing the alpha-1 subunit, which is the subunit most  closely associated with sedation.
3. This binding increases the frequency with which the receptor's chloride channel opens in response to GABA.
4. Chloride ions flow into the neuron, hyperpolarising it and making it less likely to fire.

The net effect is a broad damping of neuronal excitability, which produces sedation and shortens the time it takes to fall asleep.

Pharmacokinetics in brief: zopiclone is absorbed rapidly, with peak plasma concentrations at roughly 1.5–2 hours. Its elimination half-life is around 5 hours in healthy adults, but this extends considerably — to 7 hours or more — in older people and in those with liver impairment. That extended half-life is precisely why the recommended dose is lower in those groups: the drug is still circulating when the person wakes.

Zopiclone is metabolised primarily by the liver via the CYP3A4 enzyme system, which is the source of most of its clinically important drug interactions.

Indications: What Is Zopiclone Used For?

Zopiclone is licensed in the UK for the short-term treatment of insomnia in adults, specifically where the insomnia is severe, disabling, or subjecting the person to extreme distress.

Clinical situations where a prescriber may consider it:

• Sleep-onset insomnia — persistent difficulty falling asleep.
• Sleep-maintenance insomnia — repeated night-time awakenings or difficulty returning to sleep.
• Early-morning awakening with inability to get back to sleep.
• Acute situational insomnia** — for example following bereavement, acute stress, or during a short psychiatric crisis — where a brief period of restored sleep has clear value.

Zopiclone is not appropriate for:

• Mild or occasional sleeplessness.
• Long-term or chronic insomnia as a standing treatment.
• First-line use before sleep hygiene measures and CBT-I have been considered.
• Anyone under 18 — it is not licensed in children or adolescents.
• Insomnia that is secondary to an untreated cause such as obstructive sleep apnoea, chronic pain, depression, or an overactive thyroid. In these cases the underlying condition needs treating; a hypnotic may mask it or, in the case of sleep apnoea, make it actively worse.

Dosage of Zopiclone

Dosing must always be set by your prescriber. The figures below reflect the BNF and UK product licences, but your doctor's specific instructions take priority.

Adults (18–64 years)

Adults aged 65 and over

The recommended dose is 3.75mg at bedtime. Older adults clear zopiclone more slowly and are considerably more sensitive to its sedative effects. The 3.75mg dose reflects a well-documented increase in the risk of confusion, unsteadiness, falls and hip fracture in this group.

Hepatic impairment

3.75mg is the recommended starting dose, because reduced liver metabolism raises plasma levels and prolongs the drug's effect. Zopiclone should be avoided altogether in severe hepatic impairment.

Renal impairment

A starting dose of 3.75mg is advised. Although zopiclone is cleared mainly by the liver, accumulation is possible and caution is warranted.

Duration of treatment

Treatment should be as short as possible — generally two to four weeks maximum, including any tapering period. Where possible, intermittent dosing (for example, two or three nights per week rather than every night) reduces the development of tolerance and dependence.

There is no licensed strength above 7.5mg in the UK. If 7.5mg is not producing adequate benefit, the correct response is to return to your prescriber for reassessment — not to take additional tablets. Ineffectiveness usually signals either tolerance or an undiagnosed underlying cause, and neither is solved by a larger dose.

How to Use Zopiclone Safely

Before you start

Tell your prescriber if you have, or have ever had:

• A history of drug or alcohol dependence
• Depression, or thoughts of self-harm or suicide
• Sleep apnoea or severe respiratory disease
• Myasthenia gravis
• Liver or kidney disease
• Psychosis or a personality disorder

Also give a complete list of every medicine, supplement and herbal remedy you take.

Taking your dose

• Take one tablet immediately before getting into bed — not earlier in the evening.
• Only take it when you can allow a full 7–8 hours of uninterrupted sleep ahead of you.
• Swallow the tablet whole with water. Avoid taking it with or shortly after a heavy meal, which slows absorption.
• Do not take a second tablet if you wake during the night, regardless of how long you have been awake.
• If you forget a dose, skip it. Do not double up the following night.

Things to avoid

Alcohol. This is the single most important precaution. Alcohol and zopiclone are both CNS depressants and their effects compound each other, producing profound sedation, respiratory depression, blackouts and a substantially raised risk of accidental injury.

Other sedating medicines. Opioid painkillers, benzodiazepines, sedating antihistamines, gabapentinoids, some antidepressants and antipsychotics, and herbal sedatives such as valerian all add to zopiclone's effects. The combination with opioids is particularly dangerous.

Grapefruit juice, which inhibits CYP3A4 and can raise zopiclone levels.

Driving and the law

This deserves particular attention in the UK. Under Section 5A of the Road Traffic Act 1988, zopiclone is a specified controlled drug with a statutory blood concentration limit. Driving with zopiclone above that limit is an offence in its own right, entirely separate from whether you appear impaired.

There is a statutory medical defence if the drug was prescribed to you, you took it in accordance with instructions, and your driving was not actually impaired — but you must be able to demonstrate all three. Keeping the medicine in its original labelled packaging is sensible.

In practice: if you feel drowsy, foggy, dizzy or slow the next morning, do not drive. Next-day impairment is real and measurable, and it is often worse than the person subjectively realises.

Storage

Store below 25°C in the original packaging, away from moisture and light. Keep it securely out of reach of children and anyone else — zopiclone has street value and sharing it is a criminal offence. Return unused tablets to a pharmacy for disposal.

Benefits of Zopiclone

Used correctly and for a limited period, zopiclone offers genuine advantages:

• Rapid sleep onset. Most people feel drowsy within 30–60 minutes, and studies consistently show a reduction in sleep latency.
• Improved sleep continuity — fewer awakenings and a longer total sleep time during the treatment period.
• Relief in acute crisis. Where severe insomnia is compounding an acute stressor, restoring a few nights of sleep can meaningfully break the cycle of exhaustion and anxiety.
• Relatively preserved sleep architecture. Compared with older hypnotics such as barbiturates, zopiclone has less suppressive effect on slow-wave and REM sleep, which may contribute to better perceived sleep quality.
• A shorter half-life than many benzodiazepines, meaning less accumulation with repeated nightly dosing.

A realistic framing matters here. Zopiclone treats the symptom, not the cause, and its benefits do not persist after it is stopped. The evidence base shows CBT-I produces more durable improvement in chronic insomnia than any hypnotic, with effects that continue long after the course ends. Zopiclone works best as a short bridge while the underlying problem is addressed — not as the treatment itself.

Side Effects of Zopiclone

Common

• A bitter or metallic taste — the most characteristic zopiclone side effect, affecting a large proportion of users
• Next-day drowsiness or a "hungover" feeling
• Dry mouth
• Headache
• Dizziness or unsteadiness
• Nausea

Less common but important

• Anterograde amnesia — difficulty forming new memories for the period after taking the dose
• Confusion, particularly in older adults
• Paradoxical reactions — agitation, restlessness, irritability, aggression, nightmares or worsened insomnia rather than sedation
• Low mood, anxiety, or emergence of suicidal thoughts in susceptible people
• Falls and fractures, especially in the over-65s
• Allergic reactions — rash, itching, or swelling of the face, lips or tongue (seek urgent help)

Serious risks

Complex sleep behaviours. The MHRA has issued specific warnings about sleepwalking, sleep-driving, sleep-eating and other activities carried out while not fully awake, with no memory of them afterwards. These events can be fatal. The risk is raised by alcohol and by other sedatives. If this happens even once, stop the medicine and contact your prescriber immediately.

Dependence and tolerance. Physical and psychological dependence can develop within weeks. Warning signs include needing the tablet to feel able to sleep at all, anxiety at the thought of running out, or finding the usual dose no longer works.

Withdrawal and rebound insomnia. Stopping abruptly after regular use can cause anxiety, tremor, sweating, palpitations, irritability and — in severe cases — confusion or seizures. Rebound insomnia, where sleep is temporarily worse than before treatment started, is common and frequently misread as proof the drug is still needed.

Respiratory depression, particularly in people with existing lung disease or when combined with opioids or alcohol.

Other Important Information

Drug interactions

Increase sedation (additive CNS depression): opioids, benzodiazepines, barbiturates, sedating antihistamines, gabapentin and pregabalin, some antidepressants and antipsychotics, muscle relaxants, alcohol.

Raise zopiclone levels (CYP3A4 inhibitors): clarithromycin and erythromycin, ketoconazole and itraconazole, ritonavir and other protease inhibitors, grapefruit juice.

Reduce zopiclone levels (CYP3A4 inducers): rifampicin, carbamazepine, phenytoin, phenobarbital, St John's wort.

Who should avoid zopiclone

• Anyone with severe respiratory insufficiency or significant sleep apnoea
• People with myasthenia gravis
• Those with severe hepatic impairment
• Anyone with a known hypersensitivity to zopiclone
• Under-18s — not licensed
• Pregnancy and breastfeeding — use is not routinely recommended. Zopiclone crosses the placenta and passes into breast milk; use near delivery has been associated with sedation, floppiness and withdrawal in the newborn.

Use with particular caution in anyone with a history of substance misuse, and in those with depression, where hypnotics may unmask or worsen suicidal ideation.

Stopping zopiclone

Never stop abruptly after regular use. Your prescriber will normally:

1.  Reduce from 7.5mg to 3.75mg
2.  Move to alternate nights, then to less frequent dosing
3.  Introduce CBT-I or structured sleep scheduling before and during the taper

Expect a few poor nights. Rebound insomnia is temporary and settles — it is not evidence that the medicine is still required.