Generic Name

Mirtazapine

Brand Names
Remeron, Remeronsoltab
FDA approval date: June 19, 2003
Form: Tablet

What is Remeron (Mirtazapine)?

Living with major depression can feel like being stuck under a heavy, invisible weight. The loss of interest, persistent sadness and profound fatigue can drain the color from life, making everyday tasks feel impossible. When depression also robs you of sleep and appetite, the struggle becomes even more physically and emotionally taxing. For individuals facing this specific combination of challenges, a unique antidepressant called Mirtazapine can be an especially helpful treatment.

Mirtazapine is a well-established prescription medication used to treat major depressive disorder. It belongs to a class of drugs known as tetracyclic antidepressants, which is different from the more common SSRIs (like Prozac or Zoloft). What makes Mirtazapine a distinct and valuable option is its dual effect on mood and its significant impact on promoting sleep and stimulating appetite. For this reason, it is often a first-line choice for patients with depression who are also struggling with insomnia and weight loss, offering a way to address multiple debilitating symptoms with a single medication.

What does Mirtazapine do?

Mirtazapine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD) in adults. Its primary goal is to relieve the core emotional and physical symptoms of depression.

Patients who are prescribed Mirtazapine can expect a gradual improvement in their overall well-being. The benefits often include:

  • Improved Mood: A reduction in feelings of sadness, hopelessness and worthlessness.
  • Restored Interest and Pleasure: A renewed ability to enjoy activities and engage with life.
  • Better Sleep: It is highly sedating, especially at lower doses, and can significantly help with insomnia, a common symptom of depression.
  • Increased Appetite and Potential Weight Gain: It can effectively stimulate appetite, which is beneficial for patients who have lost weight due to their depression.

Mirtazapine quickly affects sleep, but its antidepressant effects on mood take 4-6 weeks to fully manifest. Its efficacy for MDD is well-established through clinical trials and extensive real-world use.

How does Mirtazapine work?

The symptoms of depression are believed to be linked to an imbalance of chemical messengers in the brain called neurotransmitters, especially serotonin and norepinephrine. These chemicals are crucial for regulating mood, sleep and alertness.

Mirtazapine has a unique and complex mechanism of action. It works by blocking specific receptors on nerve cells in the brain, which in turn increases the release of both serotonin and norepinephrine. Think of it as opening the gates to allow more of these “feel-good” and “energizing” chemicals to flow between brain cells, which helps to improve communication in the brain’s mood circuits and alleviate depressive symptoms.

Mirtazapine distinguishes itself from other antidepressants by strongly blocking the histamine H1 receptor, leading to significant drowsiness and sedation, like many over-the-counter sleep aids. This potent antihistamine effect effectively treats insomnia and stimulates appetite, giving Mirtazapine its unique clinical profile.

Mirtazapine side effects

Like all antidepressants, Mirtazapine can cause side effects. Many are most prominent when you first start the medication and may decrease as your body adjusts.

The most common side effects are directly related to its antihistamine properties:

  • Drowsiness and Sedation
  • Increased Appetite and Weight Gain
  • Dry Mouth
  • Constipation
  • Dizziness

Mirtazapine has an FDA boxed warning for increased suicidal thoughts and behaviors in those up to 24. All patients and families must monitor for worsening depression, behavior changes, or self-harm thoughts, particularly early in treatment or after dose adjustments.

Rare but serious side effects include agranulocytosis (dangerous drop in white blood cells, contact doctor for infection signs like fever or sore throat), Serotonin Syndrome (life-threatening with other serotonin-raising medications), and activation of mania/hypomania in individuals with bipolar disorder.

You should not take Mirtazapine if you are taking a class of drugs called MAOIs. Do not drive or operate heavy machinery until you know how this medication affects you.

Mirtazapine dosage

Mirtazapine, an oral tablet, is typically taken once daily in the evening at bedtime due to its sedating effects. An orally disintegrating tablet (ODT) form is also available for those with swallowing difficulties. Dosage starts low and may increase, with lower doses often causing stronger sedation and higher doses yielding more prominent antidepressant effects.

Routine blood monitoring is generally not needed. Your doctor will monitor your depressive symptoms, side effects, and weight during regular appointments. A complete blood count (CBC) may be ordered if infection is suspected.

Does Mirtazapine have a generic version?

Yes, Mirtazapine is widely available as a generic medication. The brand name for Mirtazapine was Remeron (and Remeron SolTab for the disintegrating tablet), but the generic is now almost exclusively used. The U.S. Food and Drug Administration ensures that generic medications are just as safe, effective, and of the same quality as their brand-name counterparts (FDA, 2021). The availability of a generic makes this an affordable treatment option.

Conclusion

Mirtazapine is a highly effective and valuable antidepressant, particularly for individuals with major depression who also suffer from insomnia and poor appetite. Its unique mechanism provides a multifaceted approach to relieving some of the most burdensome symptoms of the illness.

While the side effects of sedation and weight gain can be a challenge for some, they can be a significant benefit for others. It is a powerful medication that requires careful medical supervision, especially regarding the risk of suicidal thoughts and other rare but serious side effects. Through an open and honest partnership with your healthcare provider, you can determine if Mirtazapine is the right choice to help you on your journey toward recovery and well-being.

References

  1. Food and Drug Administration (FDA). (2021). Generic Drug Facts. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
  2. Mayo Clinic. (2024). Mirtazapine (Oral Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/mirtazapine-oral-route/symptoms/drg-20067335
  3. National Institutes of Health. (2021). Mirtazapine. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a697009.html

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Brand Information

    REMERON (MIRTAZAPINE)
    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
    1INDICATIONS AND USAGE
    REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults
    2DOSAGE FORMS AND STRENGTHS
    REMERON is supplied as:
    • 15 mg tablets: Oval, scored, yellow, with "MSD" debossed on one side and "
    • 30 mg tablets: Oval, scored, red-brown, with "MSD" debossed on one side and "
    REMERONSolTab is supplied as:
    • 15 mg orally disintegrating tablets: Round, white, with "
    • 30 mg orally disintegrating tablets: Round, white, with "
    • 45 mg orally disintegrating tablets: Round, white, with "
    3CONTRAINDICATIONS
    REMERON/REMERONSolTab is contraindicated in patients:
    • Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome
    • With a known hypersensitivity to mirtazapine or to any of the excipients in REMERON/REMERONSolTab
    4ADVERSE REACTIONS
    The following adverse reactions are described in more detail in other sections of the prescribing information:
    • Hypersensitivity
    • Suicidal Thoughts and Behaviors
    • Agranulocytosis
    • Serotonin Syndrome
    • Angle-Closure Glaucoma
    • QT Prolongation and Torsades de Pointes
    • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
    • Increased Appetite and Weight Gain
    • Somnolence
    • Activation of Mania or Hypomania
    • Seizures
    • Elevated Cholesterol and Triglycerides
    • Hyponatremia
    • Transaminase Elevations
    • Discontinuation Syndrome
    • Use in Patients with Concomitant Illness
    4.1Clinical Trial Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    The data described below are from clinical trials in which REMERON/REMERONSolTab was administered to 2796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies.
    4.2Postmarketing Experience
    The following adverse reactions have been identified during post-approval use of REMERON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Cardiac disorders: ventricular arrhythmia (Torsades de Pointes)
    Endocrine disorders: hyperprolactinemia (and related symptoms, e.g., galactorrhea and gynecomastia)
    Musculoskeletal and connective tissue disorders: increased creatine kinase blood levels and rhabdomyolysis
    Psychiatric disorders: somnambulism (ambulation and other complex behaviors out of bed)
    Reproductive system and breast disorders: priapism
    Skin and subcutaneous tissue disorders: severe skin reactions, including DRESS, Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis
    5DRUG INTERACTIONS
    Table 5 includes clinically important drug interactions with REMERON/REMERONSolTab
    6DESCRIPTION
    REMERON and REMERONSolTab contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C
    Chemical Structure
    Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water.
    REMERON is available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine Each tablet contains the following inactive ingredients: colloidal silicon dioxide anhydrous, corn starch, ferric oxide (yellow), hydroxypropyl cellulose, hypromellose, magnesium stearate, lactose monohydrate, polyethylene glycol 8000, and titanium dioxide. The 30 mg tablets also contain ferric oxide (red).
    REMERONSolTab is available for oral administration as an orally disintegrating tablet containing 15, 30, or 45 mg of mirtazapine. REMERONSolTab also contains the following inactive ingredients: aspartame, citric acid anhydrous fine granular, crospovidone, hypromellose, magnesium stearate, mannitol, granular mannitol 2080, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate (Eudragit E100), povidone, sodium bicarbonate, and sugar spheres (composed of starch and sucrose).
    7CLINICAL STUDIES
    The efficacy of REMERON as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. Patients were titrated with REMERON from a dose range of 5 mg to 35 mg/day. The mean mirtazapine dose for patients who completed these 4 studies ranged from 21 to 32 mg/day. Overall, these studies demonstrated REMERON to be superior to placebo on at least 3 of the following 4 measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of REMERON over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor.
    Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings.
    In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on REMERON were randomized to continuation of REMERON or placebo for up to 40 weeks of observation for relapse. Response during the open phase was defined as having achieved a HAM-D 17 total score of ≤8 and a CGI-Improvement score of 1 or 2 at 2 consecutive visits beginning with week 6 of the 8 to 12 weeks in the open-label phase of the study. Relapse during the double-blind phase was determined by the individual investigators. Patients receiving continued REMERON treatment experienced significantly lower relapse rates over the subsequent 40 weeks compared to those receiving placebo. This pattern was demonstrated in both male and female patients.
    8HOW SUPPLIED/STORAGE AND HANDLING
    REMERON tablets are supplied as:
    9PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide).
    10PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
    NDC 78206-160-01
    REMERON®
    (mirtazapine)Tablets
    15 mg
    Rx only
    30 Tablets
    Must be dispensed with Medication Guide.
    Manuf. for: Organon USA LLC, a subsidiary of
    ORGANON & Co.,
    Jersey City, NJ 07302, USA
    Manuf. by: Organon Pharma (UK) Limited
    Cramlington, Northumberland, UK NE23 3JU
    Mirtazapine (active ingred.) made in The Netherlands.
    Formulated in UK.
    PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
    11PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label
    NDC 78206-161-01
    REMERON®
    (mirtazapine)Tablets
    30 mg
    Rx only
    30 Tablets
    Must be dispensed with Medication Guide.
    Manuf. for: Organon USA LLC, a subsidiary of
    ORGANON & Co.,
    Jersey City, NJ 07302, USA
    Manuf. by: Organon Pharma (UK) Limited
    Cramlington, Northumberland, UK NE23 3JU
    Mirtazapine (active ingred.) made in The Netherlands.
    Formulated in UK.
    PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label
    12PRINCIPAL DISPLAY PANEL - 15 mg Tablet Blister Pack Box
    NDC 78206-156-01
    30 Tablets
    ONCE-A-DAY
    Rx only
    15 mg
    Dispense the accompanying
    Manufactured by: Anesta LLC, Salt Lake City, UT 84116, USA
    PRINCIPAL DISPLAY PANEL - 15 mg Tablet Blister Pack Box
    13PRINCIPAL DISPLAY PANEL - 30 mg Tablet Blister Pack Box
    NDC 78206-158-01
    30 Tablets
    ONCE-A-DAY
    Rx only
    30 mg
    Dispense the accompanying Medication Guide to each patient.
    Manufactured by: Anesta LLC, Salt Lake City, UT 84116, USA
    PRINCIPAL DISPLAY PANEL - 30 mg Tablet Blister Pack Box
    14PRINCIPAL DISPLAY PANEL - 45 mg Tablet Blister Pack Box
    NDC 78206-159-01
    30 Tablets
    ONCE-A-DAY
    Rx only
    45 mg
    Dispense the accompanying Medication Guide to each patient.
    Manufactured by: Anesta LLC, Salt Lake City, UT 84116, USA
    PRINCIPAL DISPLAY PANEL - 45 mg Tablet Blister Pack Box
    Remeron has been selected.