"Nov. 23, 2011 -- Insomniacs wide awake in the wee hours now have a get-back-to-sleep pill -- Intermezzo.
The FDA approved the pill on Wednesday. Designed by Transcept Pharmaceuticals for people who wake in the middle of the night, the"...
(zolpidem tartrate) Extended-release Tablets
AMBIEN CR contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. AMBIEN CR (zolpidem tartrate extended-release tablets) is available in 6.25 mg and 12.5 mg strength tablets for oral administration.
Chemically, zolpidem 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. AMBIEN CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
What are the possible side effects of zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)?
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting...
What are the precautions when taking zolpidem tartrate (Ambien CR)?
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, personal or family history of sleepwalking, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).
Do not drive, use machinery, or do any activities that require...
Last reviewed on RxList: 12/16/2016
This monograph has been modified to include the generic and brand name in many instances.
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