How does it work?

Zimovane and Zimovane LS tablets both contain the active ingredient zopiclone, which is a type of medicine called a non-benzodiazepine hypnotic. It acts in the brain to aid sleep. (NB. Zopiclone is also available without a brand name, ie as the generic medicine.)

Zopiclone works by acting on receptors in the brain called GABA receptors. This causes the release of a neurotransmitter called GABA in the brain.

GABA is a neurotransmitter that acts as a natural 'nerve-calming' agent. It helps keep the nerve activity in the brain in balance, and is involved in inducing sleepiness, reducing anxiety and relaxing muscles.

Zopiclone can be used as a short-term treatment for insomnia. This includes difficulty falling asleep, waking in the night, waking early in the morning, sleeping problems related to psychiatric disorders and sleeping problems that are causing severe distress.

Zopiclone decreases the time taken to fall asleep and night-time awakenings, as well as increasing the total amount of time spent sleeping. However, it is only suitable for short-term treatment of insomnia (up to four weeks), as when used for longer periods it has a potential for dependence and addiction.

The medicine should be taken shortly before going to bed for the night.

What is it used for?

• Short-term treatment of insomnia.

Warning!

• This medicine causes drowsiness and impairs concentration and alertness. These effects may continue into the following day and are made worse by drinking alcohol. If you are affected you should avoid potentially hazardous tasks such as driving or operating machinery. Do not drink alcohol when taking this medicine.
• You should only take this medicine before going to bed at night. If you forget to take it at bedtime don’t take it at any other time, or you may end up feeling drowsy, dizzy and confused during the day.
• There have been reports of people doing things while they are asleep after taking this medicine that they do not remember when they wake up. These include sleepwalking, ‘sleep-driving’, making phone calls and preparing and eating food. These events may be more likely if you drink alcohol, or take other medicines with sedative effects (see end of factsheet) in combination with this medicine. If you think this could be happening to you, you should let your doctor know.
• This medicine is generally only suitable for short-term use (less than four weeks). If it is used for longer periods or in high doses, dependence upon the medicine may develop and withdrawal symptoms such as headaches, muscle pain, sweating, tremor, anxiety, tension, restlessness, confusion and irritability may then occur if treatment is stopped suddenly. Your body may also become tolerant to the medicine, with higher doses needed to achieve the same effect. For this reason, you should not exceed the dose of this medicine prescribed by your doctor, or take it for longer than recommended. If you are still having trouble sleeping after this time you should consult your doctor for further advice.
• Depending on how long you have been taking this medicine for, your doctor may suggest that you stop taking it gradually to avoid withdrawal effects or a return in your sleeping problems. Follow the instructions given by your doctor.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• Personality disorders.
• History of alcoholism or drug abuse.

Not to be used in

• Children and adolescents under 18 years of age.
• Severely decreased liver function.
• Abnormal muscle weakness (myasthenia gravis).
• People whose lungs are not working properly (respiratory failure).
• Syndrome involving short spells when breathing stops during sleep (sleep apnoea syndrome).
• Pregnancy.
• Breastfeeding.
• Zimovane and Zimovane LS tablets both contain lactose and are not suitable for people with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. The manufacturer recommends that it is not used during pregnancy. This is particularly important during the third trimester of pregnancy and during labour. Regular use of this medicine during the latter stages of pregnancy can cause withdrawal symptoms in the baby. Seek further medical advice from your doctor.
• If you suspect that you could be pregnant or are planning a pregnancy while taking this medicine, you should speak to your doctor about stopping treatment.
• Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant. Seek medical advice from your doctor.

Label warnings

• This medication causes drowsiness which may continue the next day. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Change in taste, such as a bitter or metallic taste.
• Disturbance of the gut such as nausea, vomiting and dry mouth.
• Headache.
• Dizziness.
• Drowsiness.
• Loss of memory (amnesia).
• Irritability.
• Confusion.
• Aggressive behaviour.
• Depressed mood.
• Sleep walking.
• Hallucinations.
• Nightmares.
• Rash or hives.
• Light headedness.
• Problems with coordination.
• Increase in the levels of certain enzymes in the liver, mainly transaminases.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you use this medicine. Similarly, check with your doctor or pharmacist before using any new medicines while using this one, to ensure that the combination is safe.

The sedative effect of this medicine will be increased if it is taken with any of the following, which can also cause drowsiness:

• alcohol
• antiepileptics, eg sodium valproate
• antipsychotics, eg chlorpromazine, haloperidol
• baclofen
• barbiturates, eg phenobarbital, amobarbital
• benzodiazepines, eg diazepam temazepam
• MAOI antidepressants, eg phenelzine
• other sleeping tablets
• sedating antihistamines, eg chlorphenamine, hydroxyzine, promethazine
• strong opioid painkillers, eg morphine, codeine
• tricyclic and related antidepressants eg amitriptyline, mirtazapine.

The following medicines may increase the amount of zopiclone in your blood and this could increase its sedative effect, as well as increase the risk of its side effects. As a result your doctor may need to prescribe a lower dose of zopiclone if you are taking any of these:

• clarithromycin
• erythromycin
• itraconazole
• ketoconazole
• ritonavir.

The following medicines may decrease the amount of drug in your blood and so could make it less effective. As a result your doctor may need to prescribe you a higher than normal dose of zopiclone if you are taking any of these:

• carbamazepine
• phenobarbital
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

If zopiclone is used with strong opioid painkillers, such as morphine, this can result in an increase in the euphoric effect that these painkillers can have. This could lead to an increased risk of psychological dependence on the painkiller.

Other medicines containing the same active ingredient

Zopiclone tablets are also available without a brand name, ie as the generic medicine.