NDAORALTABLET
Approved
Jul 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
5/8 — Partial
ROZEREM (ramelteon) by Takeda is melatonin receptor agonists [moa]. Approved for insomnia characterized by difficulty with sleep onset. First approved in 2005.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROZEREM (ramelteon) is a melatonin receptor agonist approved in 2005 for insomnia and sleep disorders. It works by selectively binding to melatonin MT1 and MT2 receptors in the brain to regulate circadian rhythm and promote sleep. Off-label use includes bipolar disorder, major depressive disorder, migraine, and other neuropsychiatric and respiratory conditions.
$1MPart D
LOE ApproachingMinimal Medicare spend ($1M, 2,213 claims in 2023) with LOE approaching signals a mature, declining brand requiring defensive positioning and generic transition planning.
Mechanism of Action
Melatonin Receptor Agonists
Pharmacologic Class:
Melatonin Receptor Agonist
Indications (1)
Clinical Trials (21)
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
Started May 2017
26 enrolled
InsomniaMajor Depressive Disorder
A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder
Started Sep 2012
0Bipolar Disorder
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
Started Aug 2012
535 enrolled
Bipolar Disorder
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
Started Dec 2011
642 enrolled
Bipolar Disorder
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
Started Dec 2011
490 enrolled
Acute Depressive Episode
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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.