Medicines & treatments centre

ZOPICLONE WARNINGS

Zopiclone should be used with caution in:
patients who are unable to tolerate certain sugars, liver or kidney disease, patients with a history of mental illness or alcohol/drug abuse.

It should not be used in:
patients who have ever had an allergic reaction to zopiclone or to any other ingredients in the medicine, patients with severe liver problems, those with a muscle disease called myasthenia gravis, patients who have difficulty breathing including when asleep (sleep apnoea), children, pregnant or breastfeeding women, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Also see list of precautions and interactions

STORAGE

Store below 25ºC or 30ºC (depending on brand) in a dry place protected from light

ZOPICLONE USES

What is it used for.

• Zopiclone is used to help patients sleep.
• It is a hypnotic, sometimes known as a sleep producer.
• In general this drug is used for the short term relief of sleeplessness (insomnia) including difficulty falling asleep at night, waking up during the night (nocturnal awakening), waking early in the morning and insomnia caused by circumstances or mental illness.
• Benefits of being on this drug can include less difficulty falling asleep at night, less waking up at night or early in the morning, relief from sleeplessness that may be causing distress or illness, and relief from sleeplessness that may be caused by events, situations or mental illness.

Listed below are the typical uses of zopiclone.

• Short term relief of sleeplessness (insomnia).

On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.

• None known

HOW TO USE/TAKE

How often do I take it?

• Take this medication by mouth usually once a day at night, swallowed whole with a glass of water.
• Use this medication regularly in order to get the most benefit from it. You should not usually be treated with zopiclone for longer than four weeks and treatment should be withdrawn gradually and not stopped immediately.
• Remember to use it at the same time each day - unless specifically told not to by your doctor.
• It may take some hours before the full benefit of this drug takes effect.
• Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

• Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

• Zopiclone may make you feel drowsy or dizzy. Therefore make sure you are not experiencing these symptoms before your drive or operate machinery including on the day after treatment. Alcohol may make these symptoms worse. Consult your doctor or pharmacist for more details.

When can I stop?

• It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

ZOPICLONE SIDE EFFECTS

• A bitter or metallic taste in your mouth
• Dry mouth
• Feeling or being sick
• Headache
• Dizziness
• Sleepiness (drowsiness)
• Irritability
• Light headedness
• Lack of co-ordination
• Aggressiveness
• Confusion
• Depression
• Forgetfulness (amnesia)
• Hallucination or nightmares (bad dreams)
• Rashes which may be itchy

If any of these persist or you consider them severe then inform your doctor or pharmacist.

Tell your doctor immediately if you develop any of the following symptoms:
skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing as any of these may be a sign of an allergic reaction.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the UK you may report side-effects to the MHRA

ZOPICLONE PRECAUTIONS

Before taking zopiclone, tell your doctor or pharmacist if you are allergic to it; or to other hypnotics; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of: have ever had an allergic reaction to zopiclone or to any other ingredients in the medicine, severe liver problems, a muscle disease called myasthenia gravis, difficulty breathing including when asleep (sleep apnoea), you are pregnant or breastfeeding, rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Before using this medication tell your doctor or pharmacist your medical history, especially any of the following if you are unable to tolerate certain sugars, have liver or kidney disease, a history of mental illness or alcohol or drug abuse.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

• Zopiclone should not be taken with alcohol as this may increase its sleep-producing (sedative) effect.

The elderly: zopiclone should be used with caution in the elderly as it may have a more powerful effect than in younger people. A lower starting dose should be used in the elderly.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

Zopiclone is not safe to take if you are, or are planning to become, pregnant.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Zopiclone is not safe to take if you are breastfeeding

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

ZOPICLONE INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

• None known

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

• Erythromycin
• Clarithromycin
• Quinupristin with dalfopristin
• Rifampicin
• Medicines for high blood pressure
• ACE inhibitors
• Adrenergic neurone blockers
• Alcohol
• Alpha-blockers
• Anaesthetics
• Angiotensin-II receptor antagonists
• Medicines for depression
• Antihistamines
• Medicines for mental illness (antipsychotics)
• Medicines for anxiety
• Medicines for epilepsy (fitting)
• Sleeping tablets
• Baclofen
• Beta-blockers
• Calcium channel blockers
• Cimetidine
• Clonidine
• Diazoxide
• Water tablets (diuretics)
• Hydralazine
• Ketoconazole
• Itraconazole
• Allopurinol
• Lofexidine
• Methyldopa
• Minoxidil
• Mirtazapine
• Moxonidine
• Nabilone
• Nitrates
• Opioid or strong painkillers
• Ritonavir
• Sodium nitroprusside
• Tizanidine
• St John's wort

This information does not contain all possible interactions. Therefore, before using zopiclone, tell your doctor or pharmacist of all the products you use.

ZOPICLONE OVERDOSE

Symptoms of overdose include sleepiness, a feeling of being unable to do anything (lethargy) and a lack of coordination of muscle movements (ataxia). If you or someone else swallows a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets contact your nearest hospital casualty department or your doctor immediately.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of zopiclone or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on 0845 4647.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.