Edluar (Zolpidem Tartrate Sublingual Tablets) Drug Information: Medication Guide and Patient Information

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May 27, 2012

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to take the rest afforded by a suspension of voluntary bodily functions and the natural suspension, complete or partial, of consciousness; cease being awake.

Physiologically, sleep is a complex process of restoration and renewal for the body. Scientists still do not have a definitive explanation for why humans have a need for sleep. We do know that sleep is not a passive process or "switching off" of body functions; sleep is believed to be important in many physiologic processes including the processing of experiences and the consolidation of memories. It is also clear that sleep is essential, not only for humans but for almost all animals.

The importance of sleep is underscored by the symptoms experienced by those suffering from sleep problems. People s...

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PATIENT INFORMATION

Medication Guide

Edluar®
[ED' – loo-ahr]
(zolpidem tartrate sublingual tablets)

Read this Medication Guide Edluar (zolpidem tartrate sublingual tablets) before you start taking Edluar (zolpidem tartrate sublingual tablets) 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 (zolpidem tartrate sublingual tablets) ?

After taking Edluar (zolpidem tartrate sublingual tablets) , 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 (zolpidem tartrate sublingual tablets) . Reported activities include:

driving a car (“sleep-driving”)
making and eating food
talking on the phone
having sex
sleep-walking.

Call your doctor right away if you find out that you have done any of the above activities after taking Edluar (zolpidem tartrate sublingual tablets) .

Important: Take Edluar (zolpidem tartrate sublingual tablets) exactly as prescribed

Do not take more Edluar (zolpidem tartrate sublingual tablets) than prescribed.
Take Edluar (zolpidem tartrate sublingual tablets) right before you get in bed, not sooner.

Do not take Edluar (zolpidem tartrate sublingual tablets) if you:

drink alcohol
take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Edluar (zolpidem tartrate sublingual tablets) with your other medicines.
cannot get a full night's sleep

What is Edluar (zolpidem tartrate sublingual tablets) ?

Edluar (zolpidem tartrate sublingual tablets) is a sedative-hypnotic (sleep) medicine. Edluar (zolpidem tartrate sublingual tablets) is used in adults for the short-term treatment of a sleep problem called insomnia. A symptom of insomnia includes:

trouble falling asleep

Edluar (zolpidem tartrate sublingual tablets) is not for children.

Edluar (zolpidem tartrate sublingual tablets) is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Edluar (zolpidem tartrate sublingual tablets) in a safe place to prevent misuse and abuse. Selling or giving away Edluar (zolpidem tartrate sublingual tablets) 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 (zolpidem tartrate sublingual tablets) ?

Do not take Edluar (zolpidem tartrate sublingual tablets) if you have had an allergic reaction to zolpidem (Ambien, Ambien CR, Zolpimist, Edluar (zolpidem tartrate sublingual tablets) ).

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 (zolpidem tartrate sublingual tablets) if you are allergic to anything in it.

See the end of this Medication Guide for a complete list of ingredients in Edluar (zolpidem tartrate sublingual tablets) .

Edluar (zolpidem tartrate sublingual tablets) may not be right for you. Before starting Edluar (zolpidem tartrate sublingual tablets) , tell your doctor 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 lung disease or breathing problems
are pregnant, planning to become pregnant, or breastfeeding

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 (zolpidem tartrate sublingual tablets) 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 (zolpidem tartrate sublingual tablets) ?

Take Edluar (zolpidem tartrate sublingual tablets) exactly as prescribed. Do not take more Edluar (zolpidem tartrate sublingual tablets) than prescribed for you.
Take Edluar (zolpidem tartrate sublingual tablets) right before you get into bed.
Do not take Edluar (zolpidem tartrate sublingual tablets) unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
For faster sleep onset, Edluar (zolpidem tartrate sublingual tablets) should NOT be taken with or right after a meal.
Do not use the tablet if the seal on the childproof blister pack is broken, or if the blister holding the tablet is broken.
To open the blister pack, separate the individual blisters at the perforations. Peel off the top layer of paper, and push the tablet through the foil.
Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
If you take too much Edluar (zolpidem tartrate sublingual tablets) or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of Edluar (zolpidem tartrate sublingual tablets) ?

Serious side effects of Edluar (zolpidem tartrate sublingual tablets) include:

getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about Edluar (zolpidem tartrate sublingual tablets) ?”)
abnormal thoughts and behavior Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
memory loss
anxiety
severe allergic reactions
Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Edluar (zolpidem tartrate sublingual tablets) .

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 (zolpidem tartrate sublingual tablets) .

The most common side effects of Edluar (zolpidem tartrate sublingual tablets) are:

drowsiness
dizziness
diarrhea
“drugged feelings”
fatigue
headache

You may still feel drowsy the next day after taking Edluar (zolpidem tartrate sublingual tablets) .

Do not drive or do any dangerous activities after taking Edluar (zolpidem tartrate sublingual tablets) 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 (zolpidem tartrate sublingual tablets) . 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 1800-FDA-1088.

How should I store Edluar (zolpidem tartrate sublingual tablets) ?

Store Edluar (zolpidem tartrate sublingual tablets) between 68° and 77°F (20° to 25°C). Protect from light and moisture.
Keep Edluar (zolpidem tartrate sublingual tablets) and all medicines out of reach of children.

General Information about Edluar (zolpidem tartrate sublingual tablets)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Edluar (zolpidem tartrate sublingual tablets) for a condition for which it was not prescribed.
Do not share Edluar (zolpidem tartrate sublingual tablets) 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 (zolpidem tartrate sublingual tablets) .

If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Edluar (zolpidem tartrate sublingual tablets) that is written for healthcare professionals. For more information about Edluar (zolpidem tartrate sublingual tablets) , call DJA Global Pharma at 1-610-558-4454 [www.orexo.com]

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.

Last reviewed on RxList: 4/16/2009
This monograph has been modified to include the generic and brand name in many instances.