Application Nr Approved Date Route Status External Links
ANDA076410 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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