Application Nr Approved Date Route Status External Links
ANDA204299 None Sublingual None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zolpidem Tartrate Is 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 ) Zolpidem Tartrate Sublingual Tablet Is 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 Tablet Is 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments