Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about zopiclone. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What this medicine is used for
Zopiclone is used to help people with sleeping difficulties (insomnia). It helps you
fall asleep and reduces the number of times you wake up during the night. It is used
for short term treatment (2-4 weeks) of insomnia. It is not recommended for use for
more than 4 weeks at a time.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine should not be used in children. The safe and effective dose of this
medicine in children and adolescents under 18 years of age has not been established.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
hay fever-like symptoms.
Do not take this medicine if you have or have had any of the following medical conditions:
severe liver problems
severe lung problems.
Do not take this medicine if you recently had alcohol or believe that you may have
alcohol in your bloodstream.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
depression, psychosis or schizophrenia or are taking medication for a mental illness
kidney or liver problems
lung problems or breathing problems
alcoholism or frequently consume alcohol
have been addicted to any drug or medicine
Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding.
Do not take this medicine until you and your doctor have discussed the risks and benefits
Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Tell your doctor if you are taking or are planning to take any other medicines. This
includes vitamins and supplements that are available from your pharmacy, supermarket
or health food shop.
Some medicines may interact with zopiclone. These include:
medicines to treat depression, anxiety and mental illness (e.g. antipsychotics)
other sedatives or tranquillisers
strong pain relievers (e.g. codeine)
antiepileptics (e.g. phenytoin, carbamazepine, phenobarbital)
certain medicines used to treat infections (e.g. rifampicin, clarithromycin, erythromycin,
ketoconazole, itraconazole, ritonavir)
St John's Wort.
If you are taking any of these, you may need a different dose, or you may need to
take different medicines. Other medicines not listed above may also interact with
How to take this medicine
Follow carefully all directions given to you by your doctor.
They may differ to the information contained in this leaflet.
Your doctor may have prescribed a different dose, depending on your condition and
if you are taking any other medicines.
How much to take
The usual dose is one tablet just before you go to bed.
Elderly people and people with liver problems may need smaller doses.
How to take it
Swallow the tablet whole with a full glass of water.
When to take it
This medicine should be taken when you are able to have a full night sleep and immediately
before you go to bed. It helps put you to sleep quite quickly.
If you take this medicine on an empty stomach it may work more quickly.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
This medicine should only be used for short periods (2 to 4 weeks). Continuous long-term
use is not recommended unless advised by your doctor.
If you forget to take it
If you forget to take the tablet before you go to bed, and you wake up late in the
night or very early in the morning, do not take it.
You may have trouble waking at your normal time.
Take the next dose the following night when you are meant to.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice or go to the Emergency department at your nearest hospital if you
think that you or anyone else may have taken too much of this medicine. Do this even
if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking this medicine
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking this medicine.
If you become pregnant whilst taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, surgery, anaesthetic or are going into hospital,
tell your doctor.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Do not take more than the recommended dose unless your doctor tells you to. This can
increase the risk of side effects.
Do not take for a longer time than the doctor has prescribed.
Do not give this medicine to anyone else, even if they have the same condition as
Do not take your medicine to treat any other complaint unless your doctor tells you
Do not drink alcohol before, with or after this medicine.
Things to be careful of
This medicine will cause drowsiness. You should not operate dangerous machinery or
drive motors for 12 hours after you take it. You should be careful the next morning
when you wake up.
Make sure you know how you react to this medicine before you drive a car or operate
machinery. This is very important if you are taking other drugs that also make you
Be careful if you are over 65 and unwell or taking other medicines.
You may be more sensitive to some of the side effects of this medicine.
You should not drink alcohol while you are taking this medicine.
The effects of alcohol could be made worse while taking this medicine.
If you have been addicted to alcohol or drugs in the past, it is important to tell
your doctor before starting this medicine.
Some medicines can cause dependence, especially when they are used regularly for longer
than a few weeks. People who have been dependent on alcohol or other drugs in the
past may have a higher chance of becoming addicted to sleep medicines.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking zopiclone.
All medicines can have side effects. Sometimes they are serious but most of the time
they are not.
Do not be alarmed by the following lists of side effects. You may not experience any
Tell your doctor if you notice any of the following:
dry mouth, bitter taste in your mouth
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
nausea, vomiting and/or diarrhoea
change in appetite
sleep walking or other behaviours whilst asleep
Alcohol can increase the risk of sleep walking or other behaviours such as driving
or eating food whilst asleep. This risk is also increased if you take more than the
Some sleep medicines may cause a short-term memory loss. When this occurs, a person
may not remember what has happened for several hours after taking the medicine. This
is usually not a problem since most people fall asleep after taking the medicine.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to zopiclone, do not take any more
of this medicine and tell your doctor immediately or go to the Emergency department
at your nearest hospital.
Symptoms of an allergic reaction may include some or all the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body rash, itching
or hives on the skin
hay fever-like symptoms.
After taking it
Sometimes when medicines are stopped suddenly, after being used for a long time, withdrawal
symptoms may occur. Symptoms of withdrawal may include insomnia, confusion, headache,
muscle cramps and sweating.
Tell your doctor if you have any problems when you stop taking this medicine.
Storage and disposal
Keep your medicine in its pack until it is time to take it.
If you take your medicine out of its pack it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Protect from light.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine left over.
What it looks like
White to off white oval film coated tablets with breakline on one side and plain on
the other side.
Blister packs of 30 tablets. AUST R 213071.
Each tablet contains 7.5 mg of zopiclone as the active ingredient.
It also contains the following inactive ingredients:
calcium hydrogen phosphate dihydrate
sodium starch glycollate type A
colloidal anhydrous silica
This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in June 2019.