NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Jan 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
3/8 — Basic
REMERON SOLTAB (mirtazapine) by Merck & Co. is disorder, is unclear. First approved in 2001.
Drug data last refreshed 2d ago
Mechanism of Action
disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Mirtazapine and Methamphetamine Drug-drug Interaction Study
Started May 2021
15 enrolled
Methamphetamine Use DisorderDrug InteractionCardiovascular Abnormalities
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
Started Oct 2008
184 enrolled
Sleep Initiation and Maintenance DisordersMental DisordersDyssomnias+2 more
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
Started Jan 2008
259 enrolled
Sleep Initiation and Maintenance Disorder; ElderlyMental DisorderDyssomnias+2 more
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
Started Nov 2007
538 enrolled
InsomniaSleep Initiation and Maintenance DisordersMental Disorders+2 more
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
Started Jun 2007
419 enrolled
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.