Eszopiclone

Treats insomnia. Sold as Lunesta. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 14, 2026, FDA lists 15 applications for Eszopiclone (sold as Lunesta), first approved Dec 15, 2004, with 1 new use approved and 0 published complete response letters.

First approved: Dec 15, 2004
Applications: 15
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $24.3M
First approved in Japan: Jan 18, 2012

Medicare Spending

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


Eszopiclone	Part D	$20.6M	+11%	219,397
Lunesta	Part D	$3.7M	-37%	557

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

ESZOPICLONE 1 MG TABLET: $0.107 per unitGeneric · -7% in a year
ESZOPICLONE 2 MG TABLET: $0.095 per unitGeneric · +9% in a year
ESZOPICLONE 3 MG TABLET: $0.091 per unitGeneric · +5% in a year

Approvals in Japan (PMDA)

First approved in Japan 85 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Lunesta, new ingredientDrugs with a new active ingredient indicated for the treatment of insomnia. · Eisai Co., Ltd. · Jan 18, 2012

Clinical Trials

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


Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep ApneaSleep Apnea, Obstructive Sleep Apnea · Yale University	Phase 3	Recruiting	Jan 12, 2026
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)Insomnia, Hypertension · University of Sao Paulo	Phase 4	Recruiting	Jun 12, 2025
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty SleepingOSA - Obstructive Sleep Apnea · Flinders University	Phase 2	Recruiting	Apr 15, 2025
The Study in Outpatient Medicine Using Nudges to Improve SleepInappropriate Prescribing · University of Southern California	Not applicable	Active, not recruiting	Oct 15, 2024
Endotypic Traits and Obstructive Sleep Apnea SurgeryObstructive Sleep Apnea · University of California, Los Angeles	Phase 2	Recruiting	Jul 20, 2023
Rescue Pharmacotherapy for OSAObstructive Sleep Apnea · Brigham and Women's Hospital	Phase 1 / Phase 2	Recruiting	Mar 24, 2022
Grain Moxibustion Treatment on Insomnia: a Randomized Controlled TrialSleep Initiation and Maintenance Disorders · Shanghai Institute of Acupuncture, Moxibustion and Meridian	Not applicable	Not yet recruiting	Jul 28, 2021

Applications

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


Dec 15, 2004	LunestaNDA 21476 · New molecular entity	Waylis Therap	19	Marketed
May 23, 2011	EszopicloneANDA 91169	Teva	6	Marketed
Jul 14, 2011	EszopicloneANDA 91165	Chartwell Rx	1	Discontinued
Sep 13, 2011	EszopicloneANDA 91124	Lupin Ltd	2	Discontinued
Mar 26, 2013	EszopicloneANDA 91151	Mylan Pharms Inc	4	Marketed
Apr 3, 2013	EszopicloneANDA 91103	Sun Pharm	1	Marketed
Apr 15, 2014	EszopicloneANDA 91024	Dr Reddys	4	Marketed
Apr 15, 2014	EszopicloneANDA 91153	Hikma	4	Discontinued
Apr 15, 2014	EszopicloneANDA 91166	Glenmark Pharms Ltd	4	Marketed
Jun 10, 2014	EszopicloneANDA 91113	Orbion Pharms	3	Marketed
Jan 30, 2015	EszopicloneANDA 202929	Macleods Pharms	5	Marketed
Sep 15, 2016	EszopicloneANDA 208451	Aurobindo Pharma	3	Marketed
May 8, 2019	EszopicloneANDA 203087	Pharmobedient	0	Discontinued
Dec 29, 2023	EszopicloneANDA 206222	Ipca Labs Ltd	0	Discontinued
Jan 4, 2024	EszopicloneANDA 205504	Hetero Labs Ltd V	0	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