Application Nr Approved Date Route Status External Links
ANDA077985 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 4-5 Weeks In Duration With The Final Formal Assessments Of Sleep Latency Performed At The End Of Treatment. 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. ( 1 )

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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