ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated, extended release
Actavis Pharma, Inc.
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ZOLPIDEM TARTRATE (zol' pi dem tar' trate) EXTENDED-RELEASE TABLETS C-IV
Read the Medication Guide that comes with zolpidem tartrate extended-release tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets may cause serious side effects that you may not know are happening to you. These side effects include:
Call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate extended-release tablets.
You should not drive a car or do things that require clear thinking the day after you take zolpidem tartrate extended-release tablets.
Do not take zolpidem tartrate extended-release tablets if you:
What are zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate extended-release tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Zolpidem tartrate extended-release tablets are not recommended for use in children under the age of 18 years.
Zolpidem tartrate extended-release tablets are a federally controlled substance (C-IV) because they can be abused or lead to dependence. Keep zolpidem tartrate extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate extended-release tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs. |
Who should not take zolpidem tartrate extended-release tablets?
Symptoms of a serious allergic reaction to zolpidem can include:
What should I tell my healthcare provider before taking zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets may not be right for you. Before starting zolpidem tartrate extended-release tablets, tell your healthcare provider about all of your health conditions, including if you:
have a history of depression, mental illness, or suicidal thoughts
have a history of drug or alcohol abuse or addiction
have kidney or liver disease
have a lung disease or breathing problems
are pregnant, planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take zolpidem tartrate extended-release tablets.
Using zolpidem tartrate in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if zolpidem tartrate is taken late in pregnancy.
are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate extended-release tablets.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate extended-release tablets with other medicines that can make you sleepy unless your healthcare provider tells you to.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take zolpidem tartrate extended-release tablets?
What are the possible side effects of zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets may cause serious side effects including:
Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using zolpidem tartrate extended-release tablets.
The most common side effects of zolpidem tartrate extended-release tablets are:
After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:
These are not all the side effects of zolpidem tartrate extended-release tablets. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
How should I store zolpidem tartrate extended-release tablets?
Store zolpidem tartrate extended-release tablets at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature].
Keep zolpidem tartrate extended-release tablets and all medicines out of reach of children.
General Information about the safe and effective use of zolpidem tartrate extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use zolpidem tartrate extended-release tablets for a condition for which it was not prescribed. Do not share zolpidem tartrate extended-release tablets with other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about zolpidem tartrate extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about zolpidem tartrate extended-release tablets that is written for healthcare professionals. For more information about zolpidem tartrate extended-release tablets call Actavis at 1-800-432-8534.
What are the ingredients in zolpidem tartrate extended-release tablets?
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: anhydrous lactose, colloidal anhydrous silica, colloidal silicon dioxide, hypromellose, light anhydrous silicic acid, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, povidone, silica, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, tartaric acid, triethyl citrate, and titanium dioxide. Additionally, the 6.25 mg strength contains polyvinyl alcohol. The 12.5 mg strength also contains polydextrose, triacetin, and yellow iron oxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA