Zaleplon

Sold as Sonata. Every FDA application for this active ingredient: 1 branded and 10 generic.

As of Nov 14, 2026, FDA lists 11 applications for Zaleplon (sold as Sonata), first approved Aug 13, 1999, with 1 new use approved and 0 published complete response letters.

First approved: Aug 13, 1999
Applications: 11
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $4.2M
First approved in the EU: Mar 12, 1999

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Zaleplon	Part D	$4.2M	+14%	50,713

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

ZALEPLON 10 MG CAPSULE: $0.149 per unitGeneric · -7% in a year
ZALEPLON 5 MG CAPSULE: $0.156 per unitGeneric · +2% in a year

Approvals in the EU (EMA)

First approved in the EU 5 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Sonata, new substanceMeda AB · Mar 12, 1999 · withdrawn
ZereneMeda AB · Mar 12, 1999 · withdrawn

Clinical Trials

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


SONATA Dose Duration LIFU for OCDObsessive - Compulsive Disorder · University of Pennsylvania	Phase 2	Recruiting	Oct 21, 2026
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis · Hoffmann-La Roche	—	Recruiting	Sep 18, 2026
SONATA LIFU for OCDObsessive Compulsive Disorder · University of Pennsylvania	Phase 2	Recruiting	Jul 27, 2026
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.Cochlear Implantation, Sensorineural Hearing Loss · MED-EL Elektromedizinische Geräte GmbH	—	Recruiting	Jul 13, 2026
A Pilot Randomized Controlled Trial of a Social Network InterventionAdvanced Cancer, Older Adults (65 Years and Older) · University of Rochester	Not applicable	Recruiting	Feb 6, 2026
The Effects of Different Time Reminder On Surgical Hand ScrubingSurgical Site Infection · Saglik Bilimleri Universitesi Gulhane Tip Fakultesi	Not applicable	Active, not recruiting	Jun 5, 2025
The Study in Outpatient Medicine Using Nudges to Improve SleepInappropriate Prescribing · University of Southern California	Not applicable	Active, not recruiting	Oct 15, 2024
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic CardiomyopathyObstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy · Lexicon Pharmaceuticals	Phase 3	Active, not recruiting	Jul 1, 2024

Applications

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


Aug 13, 1999	SonataNDA 20859 · New molecular entity	Pfizer	12	Discontinued
Jun 6, 2008	ZaleplonANDA 77237	Hikma	3	Marketed
Jun 6, 2008	ZaleplonANDA 77238	Natco Pharma	2	Discontinued
Jun 6, 2008	ZaleplonANDA 77239	Teva Pharms	1	Discontinued
Jun 6, 2008	ZaleplonANDA 78095	Upsher Smith Labs	0	Discontinued
Jun 6, 2008	ZaleplonANDA 78706	Upsher Smith Labs	2	Discontinued
Jun 6, 2008	ZaleplonANDA 78829	Aurobindo Pharma	3	Marketed
Jun 6, 2008	ZaleplonANDA 78989	Unichem	3	Marketed
Jun 20, 2008	ZaleplonANDA 77505	Chartwell Molecular	3	Marketed
Nov 25, 2008	ZaleplonANDA 78147	Hikma	1	Discontinued
Sep 17, 2009	ZaleplonANDA 90374	Orbion Pharms	3	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