NDAORALCAPSULEPriority Review
Approved
Apr 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
DALMANE (flurazepam hydrochloride) by Bausch + Lomb is 12. Approved for insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings and 1 more indications. First approved in 1970.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dalmane (flurazepam hydrochloride) is a 1,4-benzodiazepine hypnotic approved in 1970 for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. It works by binding to stereo-specific receptors in the central nervous system, though the exact mechanism remains unknown. The drug is rapidly absorbed orally and extensively metabolized, with active metabolites contributing to its clinical effects over multiple nights of use.
LOE Approaching
As a legacy product approaching loss of exclusivity with no current spending data, the Dalmane team is likely operating in maintenance mode with minimal commercial expansion or headcount growth.
Mechanism of Action
12.1 Mechanism of Action Flurazepam, like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown. 12.3…
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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.