STILNOX Film-coated tablet Ref.[50865] Active ingredients: Zolpidem

Source: Web Search  Revision Year: 2020  Publisher: Sanofi-aventis Israel ltd. 10 Beni Gaaon St, POB 8090, Netanya

Product name and form

STILNOX 10mg Tablets.

Pharmaceutical Form

Stilnox tablets are white to off-white film coated oblong tablets.

Qualitative and quantitative composition

Each tablet contains zolpidem tartrate 10 mg.

Excipients with known effect: Each Stilnox tablet contains 90.4 mg lactose monohydrate.

Stilnox contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Stilnox is available in 10 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.

Each Stilnox tablet includes the following inactive ingredients: Lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate (type A), titanium dioxide suspension, magnesium stearate and macrogol 400.

Active Ingredient Description
Zolpidem

Zolpidem is an imidazopyridine which preferentially binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which corresponds to GABA-A receptors containing the alpha-1 sub-unit, whereas benzodiazepines non-selectively bind both omega-1 and omega-2 subtypes. The modulation of the chloride anion channel via this receptor leads to the specific sedative effects demonstrated by zolpidem. These effects are reversed by the benzodiazepine antagonist flumazenil.

List of Excipients

Pack sizes and marketing

Marketing authorization holder

Sanofi-aventis Israel ltd. 10 Beni Gaaon St, POB 8090, Netanya

Marketing authorization dates and numbers

1045127587

Drugs

Drug Countries
STILNOX Brazil, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Israel, Lithuania, Malta, Mexico, Poland, Romania, Singapore, Tunisia, South Africa

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