Application Nr Approved Date Route Status External Links
ANDA090107 2011-07-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zolpidem Tartrate Extended-Release Tablets Are 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 [see Clinical Studies (14) ]. Zolpidem Tartrate Extended-Release Tablets A Gamma-Aminobutyric Acid (gaba) A Agonist, Are Indicated For The Treatment Of Insomnia Characterized By Difficulties With Sleep Onset And/or Sleep Maintenance. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Ferric Oxide Red FERRIC OXIDE RED Molecular
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zolpidem Tartrate ZOLPIDEM TARTRATE ZINC3876

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