Application Nr Approved Date Route Status External Links
ANDA078989 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Zaleplon Capsules Are Indicated For The Short-Term Treatment Of Insomnia. Zaleplon Capsules Have 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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