NDAORALCAPSULE
Approved
Aug 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
SONATA (zaleplon) by Pfizer is clinical pharmacology ). First approved in 1999.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sonata (zaleplon) is a short-acting non-benzodiazepine hypnotic (pyrazolopyrimidine) approved in 1999 for the treatment of insomnia. It works by enhancing GABA-A receptor signaling in the central nervous system to facilitate sleep onset. Zaleplon's short half-life and lack of active metabolites differentiate it from longer-acting alternatives, reducing next-day residual effects.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100); team focus likely shifting toward generic transition planning and market defense rather than growth initiatives.
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.