Lunesta

Treats insomnia. NDA 21476, held by Waylis Therap. Eszopiclone.

As of Nov 14, 2026, NDA 21476 (Lunesta), held by Waylis Therap, was first approved by FDA on Dec 15, 2004, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2004
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LUNESTA (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Oct 10, 2012	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Dec 15, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Lunesta1MG · tablet;oral	Eszopiclone	RxReference drug
Lunesta2MG · tablet;oral	Eszopiclone	RxReference drug
Lunesta3MG · tablet;oral	Eszopiclone	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Aug 18, 2019	Supplement 38Labeling	Approved	Label Medication Guide Letter
Feb 6, 2019	Supplement 37Labeling	Approved	Letter Label
Nov 7, 2018	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 27, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Feb 16, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 3, 2014	Supplement 31Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
May 15, 2014	Supplement 30Labeling · Standard review	Approved	Letter Label
Apr 4, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 3, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 10, 2012	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Oct 10, 2012	Supplement 24Labeling	Approved	Letter Label
Jan 26, 2012	Supplement 21Labeling	Approved	Letter
Sep 30, 2009	Supplement 15Labeling · Standard review	Approved	None posted
Apr 23, 2009	Supplement 11Manufacturing	Approved	None posted
Apr 6, 2009	Supplement 12Manufacturing	Approved	Label Letter
Jan 29, 2008	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 29, 2008	Supplement 5Labeling · Standard review	Approved	Letter Label
May 23, 2006	Supplement 4Manufacturing	Approved	None posted
Dec 15, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21476
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters