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AMBIEN®
(zolpidem tartrate) tablets, for oral use

DESCRIPTION
AMBIEN contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolyl imidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1).

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 AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

INDICATIONS
AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies].

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Dosage In Adults
Use the lowest effective dose for the patient.ing and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of AMBIEN should not exceed 10 mg once daily immediately before bedtime.

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The recommended initial doses for women and men are different because zolpidem clearance is lower in women.