Application Nr Approved Date Route Status External Links
ANDA091151 2013-03-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Eszopiclone Tablets Are Indicated For The Treatment Of Insomnia. In Controlled Outpatient And Sleep Laboratory Studies, Eszopiclone Tablets Administered At Bedtime Decreased Sleep Latency And Improved Sleep Maintenance. The Clinical Trials Performed In Support Of Efficacy Were Up To 6 Months In Duration. The Final Formal Assessments Of Sleep Latency And Maintenance Were Performed At 4 Weeks In The 6-Week Study (adults Only), At The End Of Both 2-Week Studies (elderly Only) And At The End Of The 6-Month Study (adults Only). Eszopiclone Tablets Are Indicated For The Treatment Of Insomnia. Eszopiclone Tablets Have Been Shown To Decrease Sleep Latency And Improve Sleep Maintenance. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Eszopiclone ESZOPICLONE ZINC19632834