(zolpidem tartrate) film-coated tablet
Consumer Medicine Information
Warning: Zolpidem may be associated with unusual and potentially dangerous behaviours whilst apparently asleep. These have included sleep walking, driving motor vehicles and other bizarre behaviours. Some medicines may interact with zolpidem and particular caution is needed with other drugs that may also act on the brain. Before you take zolpidem, refer to the "Taking other medicines" section below or ask your doctor or pharmacist. You must not drink alcohol when you take zolpidem. Do not take zolpidem for more than 4 weeks. If your sleep problems continue, consult your doctor.
What is in this leaflet
This leaflet answers some common questions about Zolpibell.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Zolpibell 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 need to read it again.
What Zolpibell is used for
Zolpibell is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia. It is not recommended for use for more than 4 weeks at a time.
Zolpibell has a different chemical structure to other sleeping tablets. Zolpibell works by binding to special sites in the brain which produce sleep.
Your doctor, however may prescribe Zolpibell for another purpose.
Ask your doctor or pharmacist if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor’s prescription.
Before you take Zolpibell
When you must not take it
Do not take Zolpibell if you have:
- been drinking alcohol or you believe that you may have alcohol in your bloodstream;
- sleep apnoea (a condition where you temporarily stop breathing while you sleep);
- myasthenia gravis (a condition in which the muscles become weak and tire easily);
- severe liver problems;
- acute and/or severe lung problems.
Do not take Zolpibell if you are allergic to it or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not give Zolpibell to a child or adolescent. There is no experience with its use in children or adolescents under 18 years of age.
Do not take Zolpibell if you are pregnant, suspect that you are pregnant or intend to become pregnant. It may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.
Do not take Zolpibell if you are breastfeeding or planning to breastfeed. Zolpibell passes into breast milk and there is a possibility your baby may be affected. Your doctor will discuss the risks and benefits of using it if you are breastfeeding or planning to breastfeed.
Do not take Zolpibell after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.
Do not take Zolpibell if the packaging is damaged or shows signs of tampering.
Before you start to take it
Tell your doctor if you have allergies to any of the ingredients listed at the end of this leaflet.
Tell your doctor if you are pregnant, suspect that you are pregnant or intend to become pregnant. Like most medicines of this kind, Zolpibell is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.
Tell your doctor if you are breastfeeding or planning to breastfeed. Zolpibell can pass into breast milk. Your doctor will discuss the risks and benefits of using it if you are breastfeeding or planning to breastfeed.
Tell your doctor if you have any problems with your breathing or if you often snore while you are asleep.
Tell your doctor if you have ever been addicted to alcohol or any drug or medicine or if you have ever suffered from a mental illness. If you have, you may be at risk of getting into a regular pattern or habit of taking Zolpibell.
Tell your doctor if you have or have had any medical conditions, especially the following:
- problems with your heart, liver, kidneys or lungs;
- mental illness, for example schizophrenia.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you take Zolpibell.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
Some medicines may interfere with Zolpibell. These include:
- medicines to treat depression, anxiety and mental illness;
- medicines to treat epilepsy;
- pain relievers;
- muscle relaxants;
- St John’s Wort (also known as Hypericum), a herbal remedy used to treat depression;
- medicines to treat infections, such as rifampicin or ciprofloxacin;
- ketoconazole, a medicine to treat antifungal infections.
These medicines may be affected by Zolpibell, or may affect how well it works, ie. by increasing drowsiness. This may affect your ability to drive a car or operate dangerous machinery. You may need to use different amounts of your medicine, or take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Zolpibell.
How to take Zolpibell
How much to take
Zolpibell should only be taken when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. It should be taken in one dose and not be re-administered during the same night.
The usual adult dose of Zolpibell is one tablet (10 mg).
If you are over 65 years of age, the dose is half a Zolpibell tablet (5 mg).
If you have a liver problem, the usual recommended dose is half a Zolpibell tablet (5 mg).
Your doctor may have prescribed a different dose. The lowest effective daily dose should be used and must not exceed 10 mg.
Ask your doctor if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Zolpibell may not work as well. If you take too much your consciousness may be impaired (see ‘If you take too much (overdose)’ below).
Zolpibell should not be given to children or adolescents less than 18 years of age.
How to take it
Swallow the tablet whole with a full glass of water, unless your doctor has told you to take half a tablet.
When to take it
Take Zolpibell immediately before you go to bed or while you are in bed. It helps put you to sleep quite quickly. If you take Zolpibell on an empty stomach it may work more quickly.
If you are not sure when to take it ask your doctor or pharmacist.
How long to take it
Usually, Zolpibell or any other medicines to treat sleeping disorders should only be used for short periods (eg. 2 to 4 weeks). Continuous long-term use is not recommended unless advised by your doctor.
Ask your doctor or pharmacist if you are not sure how long to take the medicine for.
you forget to take it
If you forget to take Zolpibell before you go to bed, and you wake up late in the night or very early in the morning, do not take any Zolpibell. You may have trouble waking at your normal time.
If you are not sure what to do, ask your doctor.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Zolpibell.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much Zolpibell, your consciousness may be impaired, ranging from drowsiness to light coma.
While you are taking it
Things you must do
- Tell all the doctors, dentists and pharmacists who are treating you that you are taking Zolpibell.
- If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Zolpibell.
- If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
- If you become pregnant or suspect that you are pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately.
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 drink alcohol before or after taking this medicine. This can increase the risk of side effects.
- Do not give this medicine to anyone else, even if they have the same condition as you.
- Do not use this medicine to treat any other complaints unless your doctor tells you to.
Things to be careful of
Because Zolpibell will make you sleepy, you should not operate dangerous machinery or drive motor vehicles for 8 hours after you take it. You should also be careful the next morning when you wake up.
Make sure you know how you react to Zolpibell before you drive a car or operate machinery. This is very important if you are taking other drugs that also make you drowsy.
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 Zolpibell. Some patients may be particularly susceptible to the sedative effects of the medication, which may increase the possibility of a fall.
You should not drink alcohol while you are taking Zolpibell. The effects of alcohol could be made worse while taking Zolpibell.
All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor as soon as possible if you do not feel well while you are taking Zolpibell. It helps most people with insomnia, but it may have unwanted side effects in some people.
Tell your doctor if you notice any of the following and they worry you:
- worsened insomnia;
- diarrhoea, nausea and vomiting;
- abdominal pain;
- back pain;
- muscle weakness;
- infection of the nose, throat and chest.
These are the most common side effects of Zolpibell.
Less common adverse effects include:
- unexpected changes in behaviour. These have included rage reactions, confusion and other forms of unwanted behaviour.
- sleep walking, driving motor vehicles and other unusual, and on some occasions dangerous, behaviours whilst apparently asleep. These have also included preparing and eating food, making phone calls or having sexual intercourse. People experiencing these effects have had no memory of the events.
Alcohol can increase the risk of sleep walking and other related behaviours. These side effects can also occur without the presence of alcohol.
Although these side effects can occur at the usual recommended doses, the risk of these behaviours occurring may also be increased if you take more than the recommended dose.
Some sleep medicines may cause 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.
Sleep medicines should in most cases, be used only for short periods of time. If your sleep problems continue, consult your doctor.
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. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting Zolpibell.
If any of the following happen, stop taking Zolpibell and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
These are very serious side effects. If you have them, you may have had a serious allergic reaction to Zolpibell. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some consumers.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
After taking Zolpibell
Sometimes when medicines are stopped suddenly, after being used for a long time, withdrawal symptoms may occur. Symptoms of withdrawal may include abdominal and muscle cramps, vomiting and sweating.
In some cases, your insomnia may appear worse for a shorttime; speak to your doctor if this occurs.
Patients taking part in trials have not had any problems when they stopped taking this product.
However, let your doctor know if you have any problems when you stop taking Zolpibell
If you have any queries about any aspects of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.
- Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.
- Keep the medicine in a cool, dry place where the temperature stays below 25°C.
- Do not store Zolpibell or any other medicine in the bathroom, near a sink, or on a windowsill.
- Do not leave it in the car. Heat and damp can destroy some medicines.
- Keep it where children cannot reach it. A locked cupboard at least one-and-ahalf metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking the medicine or it has passed its expiry date, ask your pharmacist what to do with any that is left over.
Return any unused or out of date medicine to your pharmacist.
What it looks like
Zolpibell 10mg – White, oval, bi-convex, film-coated tablets, scored on both sides and embossed with "ZIM 10" on one side.
Zolpibell is available in blister packs containing 14 ta
Each Zolpibell tablet contains zolpidem tartrate as the active ingredient.
Each tablet also contains the following inactive ingredients:
- lactose monohydrate;
- microcrystalline cellulose;
- sodium starch glycollate;
- magnesium stearate.
The coating contains:
- titanium dioxide (E171);
- Macrogol 400.
Australian Registration Numbers
Zolpibell 10mg AUST R 119087.
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill VIC 3128
Telephone: +61 3 9809 7900
This leaflet was prepared in May 2019
Published by MIMS July 2019