Application Nr Approved Date Route Status External Links
ANDA204229 None Sublingual None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zolpidem Tartrate Sublingual Tablets Are Indicated For Use As Needed For The Treatment Of Insomnia When A Middle-Of-The-Night Awakening Is Followed By Difficulty Returning To Sleep. Limitations Of Use: Zolpidem Tartrate Sublingual Tablets Are Not Indicated For The Treatment Of Middle-Of-The-Night Insomnia When The Patient Has Fewer Than 4 Hours Of Bedtime Remaining Before The Planned Time Of Waking. Zolpidem Tartrate Sublingual Tablets Are A Gaba A Agonist Indicated For Use As Needed For The Treatment Of Insomnia When A Middle-Of-The-Night Awakening Is Followed By Difficulty Returning To Sleep (1) Limitation Of Use : Not Indicated For The Treatment Of Middle-Of-The Night Awakening When The Patient Has Fewer Than 4 Hours Of Bedtime Remaining Before The Planned Time Of Waking (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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