Application Nr Approved Date Route Status External Links
ANDA078179 2011-06-06 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, Usp 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, Usp 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 (12 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. Tartaric Acid TARTARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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