EDLUAR- zolpidem tartrate tablet
Meda Pharmaceuticals Inc.
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Medication Guide
Edluar® [ED’ – loo-ahr]
(zolpidem tartrate)
sublingual tablets C-IV
Read this Medication Guide that comes with Edluar 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 Edluar?
Edluar may cause serious side effects, including:
Stop taking Edluar and call your healthcare provider right away if you find out that you have done any of the above activities after taking Edluar.
Do not take Edluar if you:
What is Edluar?
Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).
It is not known if Edluar is safe and effective in children under the age of 18 years.
Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Edluar?
Symptoms of a serious allergic reaction to zolpidem can include:
What should I tell my healthcare provider before taking Edluar?
Edluar may not be right for you. Before starting Edluar, tell your healthcare provider about all of your health conditions, including if you:
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 Edluar with other medicines that can make you sleepy, unless directed by your healthcare provider.
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 Edluar?
What are the possible side effects of Edluar?
Edluar 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 Edluar.
The most common side effects of Edluar are:
You may still feel drowsy the next day after taking Edluar.
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 Edluar. Ask your doctor or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Edluar?
Keep Edluar and all medicines out of reach of children.
General information about the safe and effective use of Edluar
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Edluar for a condition for which it was not prescribed.
Do not share Edluar with other people, even if you think 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 Edluar.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Edluar that is written for healthcare professionals.
For more information about Edluar, call Meda Pharmaceuticals Inc. at 1-866-444-7799.
What are the ingredients in Edluar?
Active Ingredient: zolpidem tartrate
Inactive Ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
This Medication Guide has been approved by U.S. Food and Drug Administration.
Manufactured by:
Mylan Laboratories Limited
Hyderabad – 500 096, India
Manufactured for:
Meda Pharmaceuticals Inc.
Somerset, NJ 08873-4120
© 2022 Viatris Inc.
U.S. Patents 9,265,720; 9,597,281
EDLUAR is a registered trademark of Meda Pharmaceuticals Inc., a Viatris company.
The brands listed are trademarks of their respective owners.
MX-IG-6010-03 Rev. 8/2022 75092793