Application Nr Approved Date Route Status External Links
ANDA078989 2008-06-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Zaleplon Is Indicated For The Short-Term Treatment Of Insomnia. Zaleplon Has Been Shown To Decrease The Time To Sleep Onset For Up To 30 Days In Controlled Clinical Studies (see Clinical Trials Under Clinical Pharmacology). It Has Not Been Shown To Increase Total Sleep Time Or Decrease The Number Of Awakenings. The Clinical Trials Performed In Support Of Efficacy Ranged From A Single Night To 5 Weeks In Duration. The Final Formal Assessments Of Sleep Latency Were Performed At The End Of Treatment.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. 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.
4. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
5. Gelatin GELATIN Unresolved
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zaleplon ZALEPLON ZINC6300