ANDAORALCAPSULE1 Generic Approved
Approved
Jun 2008
Lifecycle
Post-LOE
Competitive Pressure
45/100
Clinical Trials
2
Data completeness
5/8 — Partial
ZALEPLON (zaleplon) by Hikma is gaba a agonists [moa]. Approved for gamma-aminobutyric acid a receptor agonist [epc]. First approved in 2008.
Drug data last refreshed 18h ago
$0.0BPart D
Mechanism of Action
GABA A Agonists
Pharmacologic Class:
gamma-Aminobutyric Acid A Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Zaleplon 10mg Capsules Under Fasting Conditions
Started Feb 2004
40 enrolled
Healthy
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
Started Feb 2004
42 enrolled
Healthy
Company
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.