Edluar

DRUG 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:

Edluar (zolpidem tartrate) Structural Formula Illustration

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 (zolpidem tartrate sublingual tablets) tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.

What are the precautions when taking zolpidem tartrate sublingual tablets (Edluar)?

Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Edluar


Edluar Consumer (continued)

SIDE EFFECTS: Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Older adults may be more sensitive to the effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor.

A small amount of this medication passes into breast milk. Consult your doctor before breast-feeding.



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