NDAORALCAPSULE
Approved
Aug 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
SONATA (zaleplon) by Pfizer is clinical pharmacology ). First approved in 1999.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sonata (zaleplon) is a non-benzodiazepine hypnotic (pyrazolopyrimidine) indicated for short-term treatment of insomnia. It works by binding to GABA-A receptors in the central nervous system, promoting sleep onset. Zaleplon has a short half-life and no active metabolites, distinguishing it from other rapidly-eliminated hypnotics.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating shrinking team focus and potential transition to generic support or portfolio reallocation.
Mechanism of Action
CLINICAL PHARMACOLOGY ). Sonata is not recommended for use in patients with severe hepatic impairment. under ) ). ). Withdrawal-Emergent Anxiety and Insomnia During nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of hypnotics may develop. If the drug has…
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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.