Application Nr Approved Date Route Status External Links
ANDA078970 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zolpidem Tartrate Extended-Release Tablet, A Gamma-Aminobutyric Acid (Gaba) A Receptor Positive Modulator, Is Indicated For The Treatment Of Insomnia Characterized By Difficulties With Sleep Onset And/or Sleep Maintenance. ( 1 ) 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 )].

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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