Consumer Medicines Information - Zolpidem-GA Tablets - myDr.com
Consumer Medicine Information. Warning: Zolpidem may be associated with unusual and potentially dangerous behaviours whilst apparently asleep.
Published by MIMS January 2011.
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.
Swallow the tablet whole with a full glass of water unless your doctor has told you to take half a tablet.
ZOLPIDEM-GA will add to the effects of alcohol and other central nervous system (CNS) depressant medicines that cause drowsiness. Some examples of CNS depressants are:
l your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
All medicines have risks and benefits. Your doctor has weighed the risk of taking ZOLPIDEM-GA against the benefits it is expected to have for you.
Do not stop taking ZOLPIDEM-GA or lower the dose without checking with your doctor. Stopping this medicine suddenly, especially when you are on a high dose or have been taking it for a long time, may cause some unwanted effects such as mood changes, anxiety and restlessness.
After taking ZOLPIDEM-GA for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.
If you are over 65 years of age the dose is 5mg (half of the 10mg) ZOLPIDEM-GA at night.
The usual adult dose of ZOLPIDEM-GA is 10 mg.
Some signs and symptoms of taking too much ZOLPIDEM-GA include severe drowsiness, clumsiness or unsteadiness, mental or mood changes, unusual tiredness or weakness and unconsciousness.
Alcohol can increase the risk of sleep walking and other related behaviours. These side effects can also occur without the presence of alcohol.
ZOLPIDEM-GA works by binding to special sites in the brain which produce sleep.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
Do not store it 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.
Less common side effects include:
It should not be used for more than 4 weeks at a time. Continuous long term use is not recommended unless advised by your doctor.
Let your doctor know if you have used ZOLPIDEM-GA before and if you had any problems with it.
These are the more common side effects of ZOLPIDEM-GA. Mostly, these are mild and short-lived.
Do not use ZOLPIDEM-GA to treat any other complaint unless your doctor says so.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If you develop any unusual and strange thoughts or abnormal behaviour while you are taking ZOLPIDEM-GA, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as aggression, hallucinations (seeing, hearing, or feeling things that are not there), and unusual excitement, nervousness, or irritability.
Other side effects not listed above may also occur in some people. l your doctor if you notice any other effects and they worry you.
The use of ZOLPIDEM-GA may lead to dependence on the medicine.
Keep all your doctor’s appointments so that your progress can be monitored.
Ascent Pharma Pty Ltd 151-153 Clarendon St South Melbourne Vic. 3205.
ZOLPIDEM-GA is used to initiate sleep in those with sleeping difficulties, also called insomnia. The cause of sleeping problems should be known, if possible. The causes should be treated before ZOLPIDEM-GA, or any hypnotic is prescribed.
If you or someone else has taken too much ZOLPIDEM-GA, immediay ephone your doctor or the Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
ZOLPIDEM-GA tablets are available in pack sizes of 14 tablets. Active ingredient: Inactive ingredients: The coating contains: www.ascentpharma.com.au.
Keep it 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 you have any concerns about taking this medicine, ask your doctor or pharmacist.
These medicines may be affected by ZOLPIDEM-GA, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Always follow your doctor’s instructions carefully.
l your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think it was not effective and change your treatment unnecessarily.
l your doctor if you have or have had any medical conditions, especially the following:
You have a healthy weight for your height.
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Your doctor or pharmacist has weighed the risk of using this medicine against the benefits they expect it will have for you.
Do not give ZOLPIDEM-GA to children and adolescents under 18 years of age unless advised by your child’s doctor. The safety and effectiveness of ZOLPIDEM-GA in this age group have not been established.
l your doctor if you become pregnant while taking ZOLPIDEM-GA.
If you are about to start taking a new medicine, l your doctor and pharmacist that you are taking ZOLPIDEM-GA.
You are over optimum weight for your height. You may be facing health problems, so losing some weight would be a good idea.
ZOLPIDEM-GA 10 mg tablets are white, oval, biconvex, film-coated tablets, scored on both sides and embossed with "ZIM" and "10" on one side.
In particular, l your doctor if you take any of the following:
For further information call 1800 554 414.
Your doctor will advise you to slowly reduce your dose of ZOLPIDEM-GA before you can stop taking it compley.
Select from our A to Z index of CMI (Consumer Medicines Information) leaflets for both prescription and over-the-counter medicines. Available as HTML, PDF and large font PDF.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
l your doctor if you plan on becoming pregnant or will be breastfeeding while you are using ZOLPIDEM-GA.
Some medicines can cause dependence, especially when they are used regularly for longer than a few weeks. People who have been dependant 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 l your doctor before starting ZOLPIDEM-GA.
l your doctor if you notice any of the following and they worry you:
It should not be used for more than 4 weeks at a time. Continuous long term use is not recommended unless advised by your doctor.
ZOLPIDEM-GA will make you sleepy, dizzy or light-headed and may therefore affect alertness. Do not drive motor vehicles or operate dangerous machinery for 8 hours after you take it. You should also be careful the next morning when you wake up. Even if you take ZOLPIDEM-GA at night, you may still be drowsy or dizzy early the next day.
Do not give this medication to anyone else, even if their symptoms seem similar to yours.
If your doctor ls you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
If you are not sure what to do or have any questions, ask your doctor or pharmacist.
If you forget to take ZOLPIDEM-GA before you go to bed and you wake up late in the night or early morning, do not take any ZOLPIDEM-GA as you may have trouble waking in the morning.
Do not take ZOLPIDEM-GA for a longer time than your doctor has prescribed. ZOLPIDEM-GA should be taken for short periods only (maximum 4 weeks), unless advised by your doctor.
Your doctor will have explained why you are being treated with ZOLPIDEM-GA and told you what dose to take. Follow these directions carefully. They may differ from the information contained in this leaflet.
Keep your tablets in a cool dry place where the temperature stays below 25°C and protect from light.
ZOLPIDEM-GA has a different chemical structure to any other sleeping tablet that is currently available in Australia.
Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
This leaflet answers common questions about ZOLPIDEM-GA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
You are under optimum weight for your height. Being underweight can carry health risks for both men and women. Check with your doctor or dietitian to find out if your current weight is healthy for you.
Some sleep medicines may cause a special type of memory loss “anterograde amnesia”. 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. To reduce this risk, ensure that you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again.
You are over optimum weight for your height. You may be facing health risks, so see your doctor to help you achieve a healthier weight.
These are very serious side effects. If you have them, you may have had a serious allergic reaction to ZOLPIDEM-GA. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Discuss with your doctor any problems or difficulties during or after taking ZOLPIDEM-GA.
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.
If you have a liver problem, you should start with 5 mg (half of the 10mg) ZOLPIDEM-GA, taken at night. If necessary, this can be increased to 10 mg.
Do not take ZOLPIDEM-GA with alcohol, as combining ZOLPIDEM-GA and alcohol can increase the risk of sleep walking and other associated behaviours (see SIDE EFFECTS).
This leaflet was prepared in June 2010. AUST R 119091.
Sleep medicines should in most cases, be used only for short periods of time. If your sleep problems continue, consult your doctor.
When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep.
Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.
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Do not take ZOLPIDEM-GA if:
Keep this leaflet with the medicine. You may want to read it again.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
Check with your doctor or pharmacist before taking any of the above or any other medicines with or without a prescription while you are using ZOLPIDEM-GA.
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ZOLPIDEM-GA should be taken just before you go to bed because it puts you to sleep quite quickly. It works more quickly if you take it on an empty stomach.
If any of the following happen, stop taking ZOLPIDEM-GA and l your doctor immediay, or go to Accident and Emergency at your nearest hospital:
Use with caution in the elderly or debilitated patient.
l your doctor if you have allergies to: