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Mirtazapine (Mirtazapine) - Summary


Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.  Anyone considering the use of mirtazapine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.  Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).



Mirtazapine tablets, USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds.

Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. 

The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). 

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. 

The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. 

The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).

See all Mirtazapine indications & dosage >>


Media Articles Related to Mirtazapine

Brain Inflammation Tied to Depression, Suicidal Thoughts
Source: Medscape Pathology & Lab Medicine Headlines [2017.09.29]
Animal and postmortem studies point to a link between neuroinflammation and depression and suicidality. This study used PET scans to corroborate these findings in living human beings.
Medscape Medical News

Sleep Deprivation a Rapid, Effective Depression Treatment
Source: Medscape Psychiatry & Mental Health Headlines [2017.09.27]
Sleep deprivation therapy may offer a rapid and effective treatment for depression, but results are short-lived. The question now is how to sustain benefit.
Medscape Medical News

Postpartum Depression Likely to Recur With Future Pregnancies
Source: MedicineNet Depression Specialty [2017.09.27]
Title: Postpartum Depression Likely to Recur With Future Pregnancies
Category: Health News
Created: 9/26/2017 12:00:00 AM
Last Editorial Review: 9/27/2017 12:00:00 AM

Cancer Patients May Have Undiagnosed Depression
Source: MedicineNet Depression Specialty [2017.09.25]
Title: Cancer Patients May Have Undiagnosed Depression
Category: Health News
Created: 9/25/2017 12:00:00 AM
Last Editorial Review: 9/25/2017 12:00:00 AM

Asthma Drug Tied to Nightmares, Depression
Source: MedicineNet Allergy Specialty [2017.09.22]
Title: Asthma Drug Tied to Nightmares, Depression
Category: Health News
Created: 9/21/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

more news >>

Published Studies Related to Mirtazapine

Study of the use of antidepressants for depression in dementia: the HTA-SADD trial--a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine. [2013]
compared with placebo... CONCLUSIONS: This is a trial with negative findings but important clinical

Relationships between pharmacotherapy-induced metabolic changes and improved psychopathology in schizophrenia: data from a mirtazapine and first-generation antipsychotics combination trial. [2013]
Clinical efficacy and metabolic side-effects of antipsychotics seem to correlate with each other. In this study, interrelationship of similar metabolic effects of mirtazapine and its earlier reported desirable effects on psychopathology in first-generation antipsychotics (FGAs)-treated schizophrenia were explored...

Mirtazapine to reduce methamphetamine use: a randomized controlled trial. [2011.11]
CONTEXT: No approved pharmacologic treatments for methamphetamine dependence exist. Methamphetamine use is associated with high morbidity and is a major cofactor in the human immunodeficiency virus epidemic among men who have sex with men (MSM). OBJECTIVE: To determine whether mirtazapine would reduce methamphetamine use among MSM who are actively using methamphetamine... CONCLUSION: The addition of mirtazapine to substance use counseling decreased methamphetamine use among active users and was associated with decreases in sexual risk despite low to moderate medication adherence. Trial Registration clinicalTrials.gov Identifier NCT00497081.

Adjunct mirtazapine for negative symptoms of schizophrenia. [2011.10]
Negative symptoms of schizophrenia are characterized by affective flattening, alogia, avolition, and anhedonia and are often nonresponsive to antipsychotic therapy. Because negative symptoms are predictive of poor occupational and social functioning, as well as poor global outcomes, numerous studies evaluating adjunct therapy to antipsychotics have been conducted...

Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial. [2011.07.30]
BACKGROUND: Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo... INTERPRETATION: Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered. FUNDING: UK National Institute of Health Research HTA Programme. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

more studies >>

Clinical Trials Related to Mirtazapine

A Placebo-Controlled Study of Mirtazapine for PTSD [Completed]
The primary objective is to evaluate the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Primary Hypothesis to be tested: Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo. After completion of the placebo-controlled phase, patients who agree to continue in the study will be treated with open-label mirtazapine for an additional 8 weeks.

Evaluation of Mirtazapine and Folic Acid for Schizophrenia: [Recruiting]
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia

Pharmacogenetic Study of Mirtazapine Response in Depressed Patients [Recruiting]
The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Mirtazapine Versus Placebo in Functional Dyspepsia [Recruiting]
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily

Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer [Recruiting]
Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

more trials >>

Reports of Suspected Mirtazapine Side Effects

Completed Suicide (101)Neuroleptic Malignant Syndrome (96)Anxiety (84)Convulsion (81)Fall (80)Toxicity TO Various Agents (80)Confusional State (79)Dizziness (74)Depression (72)Drug Interaction (71)more >>


Based on a total of 6 ratings/reviews, Mirtazapine has an overall score of 4.83. The effectiveness score is 4.33 and the side effect score is 6.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Mirtazapine review by 30 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Chronic insomnia
Dosage & duration:   30 mg taken take one hour before bed for the period of 7 months
Other conditions:   Anxiety, panic attacks
Other drugs taken:   Epilium
Reported Results
Benefits:   -night time sleep (at least 5-6 hours per night), more"peaceful" state of mind, no anxiety attacks, better brain function( no "brain fog" from insomnia), better concentration skills,
Side effects:   Constant feeling of hunger( feeling of empty stomach even straight after meal), body weight increased, fluid retention around knees and ankles, very bad depression during first 1-1.5 weeks if taking medication( no withdrawal symptoms though while gradual stopping drug), drug made me sleepy and more tired than usual during the day, crankiness and bad moods in the morning, hard to wake up in the morning
Comments:   Hour before bed: 30 mg mirtazapine( avanza) and one 500 mg epilim-ec. Epilim is used in treatment as a mood stabiliser( was told by a doctor). Originally I took only 30 mg of mirtazapine before bed time but after a month of treatment I stopped sleeping again and doctor prescribed to take extra tablet epilim which worked very well and gave me very good deep sleep


Mirtazapine review by 19 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Depression, Anxiety, OCD, Nausea
Dosage & duration:   30mg taken once a day for the period of 7 months
Other conditions:   CFS, IBS, insomnia
Other drugs taken:   Lansoprazole, Loestrin 30
Reported Results
Benefits:   Helped me easily get a good sleep. Possible reduction in IBS symptoms.
Side effects:   Too tired to get up in morning, irritability, couldn't get drunk anymore as I would drink loads and nothing would happen.
Comments:   Did little if anything for depression and anxiety. On 15mg things got worse and I got angry so easily but this went away on 30mg. I didn't put any weight on and I didn't feel very hungry on this drug and I thought that was supposed to happen.


Mirtazapine review by 22 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Depression
Dosage & duration:   15mg taken once daily for the period of 2 Months
Other conditions:   Sleeplesness
Other drugs taken:   Nil
Reported Results
Benefits:   Nil
Side effects:   -Insatiable hunger (added about 3kgs) -Constant Fatigue/grogginess -Dry Mouth at Night -Vivid Nightmares -Complete loss of labido (lame) I was pretty much miserable the entire time i was taking it, but was aware that it was supposed to start doing what it was supposed to after the first month or so, so I persevered.
Comments:   Taking before bed to help depression. Coming off the drug I felt awesome. Within a few days my energy returned as did my interest in my girlfriend. This drug was total crap. I'm now taking temazepam to help with sleeping and that is working pretty good most nights, no side effects.

See all Mirtazapine reviews / ratings >>

Page last updated: 2017-09-29

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