BMA Concise Guide to Medicine & Drugs

Zopiclone

Brand names Zimovane, Zimovane LS

Used in the following combined preparations None

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Drug group Sleeping drug

Overdose danger rating Medium

Dependence rating Medium

Prescription needed Yes

Available as generic Yes

GENERAL INFORMATION

Zopiclone is a hypnotic (sleeping drug) used for the short-term treatment of insomnia. Sleep problems can take the form of difficulty in falling asleep, frequent night-time awakenings, and/or early morning awakenings. Hypnotic drugs are given only when non-drug measures – for example, avoidance of caffeine – have proved ineffective. Unlike benzodiazepines, zopiclone possesses no anti-anxiety properties. Therefore, it may be suited for instances of insomnia that are not accompanied by anxiety – for example, international travel or change in shift work routine.

Hypnotics are intended for occasional use only. Dependence can develop after as little as one week of continuous use.

INFORMATION FOR USERS

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Tablets.

Frequency and timing of doses Once daily at bedtime when required. Tablets should be swallowed whole, without sucking or chewing.

Dosage range 3.75–7.5mg.

Onset of effect Within 30 minutes.

Duration of action 4–6 hours.

Diet advice None.

Storage Keep in original container at room temperature out of the reach of children. Protect from light.

Missed dose If you fall asleep without having taken a dose and wake some hours later, do not take the missed dose.

Stopping the drug If you have been taking the drug continuously for less than 1 week, it can be safely stopped as soon as you feel you no longer need it. However, if you have been taking the drug for longer, consult your doctor.

Exceeding the dose An occasional, unintentional extra dose is unlikely to cause problems. Large overdoses may cause prolonged sleep, drowsiness, lethargy, and poor muscle coordination and reflexes. Notify your doctor immediately.

POSSIBLE ADVERSE EFFECTS

The most common adverse effects of zopiclone are daytime drowsiness, which normally diminishes after the first few days of treatment, a bitter or metallic taste in the mouth, and headaches. Persistent morning drowsiness or impaired coordination are signs of excessive dose; if they occur, you should notify your doctor immediately. Less commonly, zopliclone may cause dizziness, weakness, nausea, vomiting, and diarrhoea; if these are severe, discuss with your doctor. Rarely, the drug may cause amnesia, confusion, or a rash; if any of these occur, you should stop taking the drug and contact your doctor immediately.

INTERACTIONS

Sedatives All drugs, including alcohol, that have a sedative effect on the central nervous system are likely to increase the sedative effects of zopiclone. Such drugs include other sleeping and anti-anxiety drugs, antihistamines, antidepressants, opioid analgesics, and antipsychotics.

Erythromycin, clarithromycin, and ketoconazole may increase the levels and effect of zopiclone, leading to adverse effects.

Carbamazepine, phenytoin, rifampicin, and St John’s wort may reduce the effects of zopiclone.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You have or have had any problems with alcohol or drug misuse/abuse.

· You have myasthenia gravis.

· You have severe respiratory disease.

· You have liver or kidney problems.

· You are taking other medicines.

Pregnancy Safety not established. Use in late pregnancy may affect the baby and cause withdrawal symptoms. Discuss with your doctor.

Breast-feeding Safety not established. The drug is present in breast milk. Discuss with your doctor.

Infants and children Not recommended.

Over 60 Increased likelihood of adverse effects. Reduced dose may therefore be necessary.

Driving and hazardous work Avoid such activities until you have learned how zopiclone affects you because the drug can cause drowsiness, reduced alertness, and slowed reactions.

Alcohol Avoid. Alcohol increases the sedative effects of this drug.

PROLONGED USE

Intended for occasional use only. Continuous use of zopiclone, or any other sleeping drug, for as little as one or two weeks may cause dependence. Withdrawal symptoms may occur when the drug is stopped. These may include insomnia, anxiety, tremor, confusion, and panic attacks. Withdrawal symptoms are less likely when the drug is used for less than 4 weeks.