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Remeron (mirtazapine)
Noradrenergic and specific serotonergic antidepressant (NaSSA) that blocks alpha-2 adrenergic, 5-HT2, 5-HT3, and H1 receptors.
Mirtazapine (Remeron) is a NaSSA antidepressant with a unique mechanism, approved in 1996. Particularly useful for depression with insomnia, poor appetite, or nausea. Available generically.
At a glance
| Generic name | mirtazapine |
|---|---|
| Also known as | Remeron, Remeron SolTab |
| Sponsor | Generic (originally Organon/MSD) |
| Drug class | NaSSA (Noradrenergic and specific serotonergic antidepressant) |
| Target | 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2C |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1996-06-14 (United States) |
Mechanism of action
Mirtazapine has a unique mechanism among antidepressants: it blocks presynaptic alpha-2 autoreceptors (increasing norepinephrine and serotonin release) and antagonizes 5-HT2 and 5-HT3 receptors (reducing anxiety and nausea). Its potent H1 antihistamine activity causes sedation and appetite stimulation, useful for depressed patients with insomnia and weight loss but problematic for others.
Approved indications
- Major depressive disorder
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Mirtazapine tablets are not approved for use in pediatric patients. ( 5.1 , 8.4 )
Common side effects
- Somnolence
- Increased appetite
- Weight gain
- Dizziness
Serious adverse events
- Suicidal thoughts and behaviors
- Agranulocytosis
- Serotonin syndrome
- Angle-closure glaucoma
- QT prolongation and torsades de pointes
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Seizures
- Hyponatremia
- Transaminase elevations
- Discontinuation syndrome
Key clinical trials
- Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients (NA)
- Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy - a Monocentric, Double-blind, Placebo-controlled Trial (Phase 4)
- Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism (Phase 4)
- Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients: A Randomized, Double-Blind Trail. (Phase 2)
- A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106 (Phase 3)
- Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study (Phase 1)
- Clinical Psychopharmacology Division,Institute of Mental Health,Peking University (NA)
- Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Remeron CI brief — competitive landscape report
- Remeron updates RSS · CI watch RSS
- Generic (originally Organon/MSD) portfolio CI