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Ambien CR
Overview
What is Ambien CR?
Ambien CR contains zolpidem tartrate, a non-benzodiazepine hypnotic 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 does Ambien CR look like?
What are the available doses of Ambien CR?
6.25 mg and 12.5 mg extended-release tablets. Tablets scored ()
What should I talk to my health care provider before I take Ambien CR?
How should I use Ambien CR?
Ambien CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration.
The dose of Ambien CR should be individualized.
What interacts with Ambien CR?
Sorry No Records found
What are the warnings of Ambien CR?
Sorry No Records found
What are the precautions of Ambien CR?
Sorry No Records found
What are the side effects of Ambien CR?
Sorry No records found
What should I look out for while using Ambien CR?
Ambien CR is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema
What might happen if I take too much Ambien CR?
How should I store and handle Ambien CR?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Ambien CR 6.25 mg tablets are composed of two layers and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number Size Ambien CR 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number SizeAmbien CR 6.25 mg tablets are composed of two layers and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number Size Ambien CR 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number SizeAmbien CR 6.25 mg tablets are composed of two layers and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number Size Ambien CR 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number SizeAmbien CR 6.25 mg tablets are composed of two layers and are coated, pink, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number Size Ambien CR 12.5 mg tablets are composed of two layers and are coated, blue, round, bi-convex, debossed with A~ on one side and supplied as:NDC Number Size
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Subunit modulation of the GABA receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties. The major modulatory site of the GABA receptor complex is located on its alpha (α) subunit and is referred to as the benzodiazepine (BZ) receptor.
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines, or other drugs with known hypnotic properties. In contrast to the benzodiazepines, which nonselectively bind to and activate all BZ receptor subtypes, zolpidem binds the BZ receptor preferentially with a high affinity ratio of the alpha/alpha subunits. The BZ receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. This selective binding of zolpidem on the BZ 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 at hypnotic doses.
Non-Clinical Toxicology
Ambien CR is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedemaThe concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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