EDLUAR- zolpidem tartrate tablet 
Meda Pharmaceuticals


17.4 Medication guide

Medication Guide

Edluar™ [ED'-loo-ahr]

(zolpidem tartrate sublingual tablets)

Read this Medication Guide Edluar before you start taking Edluar and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Edluar?

After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Edluar. Reported activities include:

Call your doctor right away if you find out that you have done any of the above activities after taking Edluar.


Take Edluar exactly as prescribed

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. A symptom of insomnia includes:

Edluar is not for children.

Edluar is a federally controlled substance (C-IV) 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?

Do not take Edluar if you have had an allergic reaction to zolpidem (Ambien®, Ambien CR, ZolpiMist, Edluar).

Some signs of allergic reaction may be swelling of the face, a feeling of the throat closing, or difficulty breathing shortly after taking Zolpidem.

Do not take Edluar if you are allergic to anything in it.

See the end of this Medication Guide for a complete list of ingredients in Edluar.

Edluar may not be right for you. Before starting Edluar, tell your doctor about all of your health conditions, including if you:

Tell your doctor 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.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Edluar?

What are the possible side effects of Edluar?

Serious side effects of Edluar include:

Call your doctor 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.

Do not drive or do any dangerous activities after taking Edluar until you feel fully awake.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain

These are not all the side effects of Edluar. Ask your doctor 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 Edluar?

General Information about Edluar

This Medication Guide summarizes the most important information about Edluar.

If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Edluar that is written for healthcare professionals.

For more information about Edluar, call Meda Pharmaceuticals at 1-800-526-3840.

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.

Rx Only

This Medication Guide has been approved

by U.S. Food and Drug Administration.

Orexo AB, Sweden

March 2009

Revised: 3/2009
Meda Pharmaceuticals