Zolpidem tartrate 12.5 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the short-term 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 [see Clinical Studies ( 14 )]. Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
Sandoz Inc
ROUND PINK SZ 229
SZ 229 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLPIDEM TARTRATE extended-release tablets, USP are available as follows: 6.25 mg, dark pink, round, biconvex film-coated tablets debossed with SZ on one side and 228 on the other side. NDC 0781-5315-31, bottles of 30 tablets NDC 0781-5315-01, bottles of 100 tablets NDC 0781-5315-05, bottles of 500 tablets 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. NDC 0781-5316-31, bottles of 30 tablets NDC 0781-5316-01, bottles of 100 tablets NDC 0781-5316-05, bottles of 500 tablets The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.
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