NDAORALTABLET
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
5/8 — Partial
LUNESTA (eszopiclone) by Viatris (2) is unclear; however, its effect could be related to its interaction with gaba-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. First approved in 2004.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUNESTA (eszopiclone) is an oral tablet hypnotic agent approved in 2004 for the treatment of insomnia. Its mechanism of action is incompletely understood but is thought to involve interaction with GABA-receptor complexes at binding domains near benzodiazepine receptors. It is a small-molecule CNS depressant used for short-term sleep induction and maintenance.
$6MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with declining Part D spending signals contraction phase; brand team will focus on managed decline and generic transition planning.
Mechanism of Action
unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder
Started Sep 2020
85 enrolled
Chronic Insomnia Disorder
Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
Started Oct 2012
4,876 enrolled
Insomnia
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
Started Oct 2012
438 enrolled
Insomnia
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Started Oct 2008
369 enrolled
Insomnia
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Started Sep 2008
192 enrolled
Primary Insomnia
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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.