Application Nr Approved Date Route Status External Links
ANDA077903 2007-08-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Zolpidem Tartrate Tablets, Usp Are Gamma-Amino Butyric Acid (gaba) A Agonist, Are Indicated For The Short-Term Treatment Of Insomnia Characterized By Difficulties With Sleep Initiation. Zolpidem Tartrate Tablets, Usp Have Been Shown To Decrease Sleep Latency For Up To 35 Days In Controlled Clinical Studies. ( 1) Zolpidem Tartrate Tablets, Usp Are Indicated For The Short-Term Treatment Of Insomnia Characterized By Difficulties With Sleep Initiation. Zolpidem Tartrate Tablets, Usp 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 4-5 Weeks In Duration With The Final Formal Assessments Of Sleep Latency Performed At The End Of Treatment.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE 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. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

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

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