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Zolpidem Tartrate

Strength: 10mg Count: 1000

NDC

42291-964-10

Class

C4

Brand Name

Ambien

Imprint Code

TEVA;74

Color(s)

WHITE (white to off-white)

Shape

ROUND

Score

no score

Case Count

72

Inactive Ingredients

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains iron oxide red.

Indications and Usage

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.