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EDLUAR- zolpidem tartrate tablet


  1. Edluar May Cause Serious Side Effects, Including:
  2. Do Not Take Edluar If You:
  3. What Is Edluar?
  4. Edluar May Not Be Right For You. Before Starting Edluar, Tell Your Healthcare Provider About All Of Your Health Conditions, Including If You:
  5. How Should I Take Edluar?
  6. The Most Common Side Effects Of Edluar Are:
  7. How Should I Store Edluar?
  8. Active Ingredient:
  9. Patient Information
  10. 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:
  11. Who Should Not Take Edluar?
  12. Serious Side Effects Of Edluar Include:
  13. Inactive Ingredients:
  14. Revised: 3/2009document Id:

Edluar May Cause Serious Side Effects, Including: 

Complex sleep behaviors that have caused serious injury and death.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 (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with Edluar whether or not you drink alcohol or take other medicines that make you sleepy.

Reported activities include:
o
driving a car ( sleep-driving )
o
making and eating food
o
talking on the phone
o
having sex
o
sleep-walking

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: 

have ever experienced a complex sleep behavior (such as driving a car, making or eating food, talking on the phone, or having sex) while not being fully awake after taking Edluar
drank alcohol that evening or before bed
took another medicine to help you sleep

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.

Edluar May Not Be Right For You. Before Starting Edluar, 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 lung disease or breathing problems
are pregnant or planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take Edluar.
using Edluar 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 Edluar is taken late in pregnancy.
are breastfeeding or plan to breastfeed. Edluar passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take Edluar.

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? 

Take Edluar exactly as prescribed. Only take 1 Edluar tablet a night and only if needed.
Do not take Edluar if you drank alcohol that evening or before bed.
You should not take Edluar with or right after a meal. Edluar may help you fall asleep faster if you take it on an empty stomach.
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. Alternatively, use scissors to open the blister.
Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
Call your healthcare provider 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 or overdose, get emergency treatment.

The Most Common Side Effects Of Edluar Are: 

drowsiness
dizziness
diarrhea
grogginess or feeling as if you have been drugged
fatigue
headache

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:

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

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? 

Store Edluar at room temperature, between 68 F and 77 F (20 to 25 C).
Protect from light and moisture.

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, go towww.meda.usor call Meda Pharmaceuticals Inc. at 1-866-444-7799.

Active Ingredient: 

zolpidem tartrate

Patient Information 

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics, should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide[

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:

  • 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.

Important

Take Edluar exactly as prescribed

  • Do not take more Edluar than prescribed.
  • Take Edluar right before you get in bed, not sooner.

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: 

  • trouble falling asleep

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.

  • Take Edluar exactly as prescribed. Do not take more Edluar than prescribed for you.
  • Take Edluar right before you get into bed.
  • Do not take Edluar 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 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 or overdose, call your doctor or poison control center right away, or get emergency treatment.

Serious Side Effects Of Edluar Include: 

  • getting out of bed while not being fully awake and do an activity that you do not know you are doing.(

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

    General Information about 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 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.

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

EDLUAR
zolpidem tartrate tablet
Product Information
Product TypeItem Code (Source)NDC:42447-112
Route of AdministrationSUBLINGUALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zolpidem tartrate(UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)5 mg
Inactive Ingredients
Ingredient NameStrength
mannitol(UNII: 3OWL53L36A)
silicified microcrystalline cellulose()
silicon dioxide, colloidal(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
saccharin sodium(UNII: SB8ZUX40TY)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains
CoatingfalseSymboltrue
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42447-112-0110 in 1 BLISTER PACK
2NDC:42447-112-0330 in 1 BLISTER PACK
3NDC:42447-112-10100 in 1 BLISTER PACK
EDLUAR
zolpidem tartrate tablet
Product Information
Product TypeItem Code (Source)NDC:42447-122
Route of AdministrationSUBLINGUALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
zolpidem tartrate(UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)10 mg
Inactive Ingredients
Ingredient NameStrength
mannitol(UNII: 3OWL53L36A)
silicified microcrystalline cellulose()
silicon dioxide, colloidal(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
saccharin sodium(UNII: SB8ZUX40TY)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains
CoatingfalseSymboltrue
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42447-122-0110 in 1 BLISTER PACK
2NDC:42447-122-0330 in 1 BLISTER PACK
3NDC:42447-122-10100 in 1 BLISTER PACK
Labeler -Meda Pharmaceuticals

Revised: 3/2009document Id: 

219CB7C9-7CBF-BF5D-8532-0EBC5D345627Set id: de965605-268a-4479-86f7-84de949cf36fVersion: 1Effective Time: 20090327Meda Pharmaceuticals



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