Estazolam

Sold as Prosom. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 14, 2026, FDA lists 4 applications for Estazolam (sold as Prosom), first approved Dec 26, 1990, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 26, 1990
Applications: 4
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Estazolam	Part D	$3.8M	+1%	8,619

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ESTAZOLAM 1 MG TABLET: $0.855 per unitGeneric · +27% in a year
ESTAZOLAM 2 MG TABLET: $0.871 per unitGeneric · +7% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug classSep 23, 2020 · boxed warning

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Compound Ciwujia Granules in the Treatment of InsomniaInsomnia Disorder · Hui Zhu	Phase 4	Not yet recruiting	Dec 29, 2025
Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by CancerCancer, Insomnia · Qinghai Red Cross Hospital	Phase 3	Recruiting	Mar 5, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 26, 1990	ProsomNDA 19080 · New molecular entity	Abbott	7	Discontinued
Jul 3, 1997	EstazolamANDA 74826	Novitium Pharma	16	Marketed
Jul 10, 1997	EstazolamANDA 74921	Dr Reddys Labs SA	8	Marketed
Aug 19, 1997	EstazolamANDA 74818	Watson Labs	11	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA