Edluar

Generic name: zolpidem
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by A Ras MD.

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.

Description

Edluar (zolpidem tartrate) sublingual tablet is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for sublingual administration.

Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.

Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.

Mechanism of action

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits.

This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses.

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

Do not take more Edluar than prescribed.
Do not take Edluar unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
Take Edluar right before you get in bed, not sooner.

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

Who should not take Edluar?

Do not take Edluar if you are allergic to zolpidem or any other ingredients in Edluar. See the end of this Medication Guide for a complete list of ingredients in Edluar.
Do not take Edluar if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include:

swelling of your face, lips, and throat that may cause difficulty breathing or swallowing
nausea and vomiting

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:

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?

See “What is the most important information I should know about 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.

What are the possible side effects of Edluar?

Edluar may cause serious side effects, including:

getting out of bed while not being fully awake and doing an activity that you do not know you are doing. See “What is the most important information I should know about Edluar?”
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. Get emergency medical help if you get these symptoms after taking Edluar.

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:

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.

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 to www.meda.us or call Meda Pharmaceuticals Inc. at 1-866-444-7799.

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.

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.

Label

PRINCIPAL DISPLAY PANEL – 10 MG

Rx Only NDC 0037-6010-93
EDLUAR® 10 mg CIV
Zolpidem Tartrate Sublingual Tablets
Each sublingual tablet (to be placed under the tongue) contains 10 mg of zolpidem tartrate. See prescribing information for dosage information.
30 Sublingual Tablets
Store at controlled room temperature 20-25ºC (68-77ºF).
Protect from light and moisture.
Do not use if blisters are torn, or seal is broken.
MX-UC-601093-01
Manufactured for:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
U.S. Patents 9,265,720; 9,597,281
EDLUAR is a registered trademark of
Meda Pharmaceuticals Inc., a Viatris Company.
Made in India
CODE No.: MH/DRUGS/25/NKD/89