Remeron (mirtazapine)
FDA Alert 05/2007: Suicidal Thoughts or Actions in Children and Adults
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.
In short-term studies, antidepressants increased the risk of suicidality in children, adolescents and young adults when compared to placebo. Taking antidepressants may increase suicidality in about 1 out of 50 people 18 years or younger. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.
Patients, their families and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
This information reflects the FDA's current analysis of data available to FDA concerning this drug.
Brand and Generic Names
Tablets and Orally Disintigrating Tablets: 15 mg, 30 mg, and 45 mg
What is Remeron® and what does it treat?
Mirtazapine is an antidepressant medication that works in the brain to correct a chemical imbalance that may be responsible for depression. It is approved for the treatment of Major Depressive Disorder (MDD).
Major Depression occurs when a person experiences at least five symptoms of depression, one of which must be either sad or depressed mood, or loss of interest in most activities. Other symptoms include changes in sleep (usually poor sleep); changes in appetite (usually decreased); loss of energy; feeling worthless/guilty/ hopeless/ helpless; psychomotor agitation or retardation (i.e. thoughts/movements speeding up or slowing down); difficulty concentrating; and thoughts of death (suicidal thinking). These symptoms must be present for a minimum of two weeks to satisfy the diagnosis of MDD.
What is the most important information I should know about Remeron®?
After starting mirtazapine, symptoms may gradually decrease over a period of weeks. Sleep and other physical symptoms may improve first before there is noticeable improvement in mood or interest in activities. Once symptoms are under control, MDD usually requires long-term treatment to help prevent the return of depressive symptoms. Only your healthcare provider can determine the length of mirtazapine treatment that is right for you.
Do not stop taking mirtazapine or change your dose without talking to with your healthcare provider first.
Because depression is also a part of Bipolar illness, people who take antidepressants such as mirtazapine may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (e.g. excessive buying sprees).
Are there specific concerns about Remeron® and pregnancy?
If you are pregnant or are planning to become pregnant, it is very important to discuss the risks and benefits of taking mirtazapine with your provider. The FDA has classified mirtazapine as Category C in regards to pregnancy risk. This means that there have not been well-controlled studies in humans examining safety or that animal studies have demonstrated adverse effects to the developing fetus.
The benefits of mirtazapine in pregnancy may still be greater than the potential risks. For instance, if depression is left untreated during pregnancy, there is a high risk for poor prenatal care and premature delivery, and the babies may exhibit developmental delays in speech, intelligence, and socialization skills. Women who stop their antidepressants after learning of a pregnancy are five times more likely to relapse than pregnant women who continue their antidepressant. Women who suffer with depression during their pregnancy are much more likely to become depressed postpartum as well.
As the risk for relapse or worsening depressive symptoms varies greatly among women during pregnancy, the decision to treat with antidepressants must be made on an individual basis. This decision is best made following thoughtful discussion with a trusted and informed health professional.
Regarding breast-feeding, it is believed that virtually all antidepressants (including mirtazapine) will pass into the breast milk. The concentrations in breast milk are generally quite low with mirtazapine even at higher doses and it would not be expected to cause adverse effects in babies. However, breastfeeding mothers should monitor their infants for behavioral side effects and adequate growth.
What should I discuss with my healthcare provider before taking Remeron®?
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The most bothersome symptoms of your condition and how often these have occurred in the past
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If you have thoughts of suicide
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Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
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Any medical problems or medication allergies that you may have
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All other medications and nutritional/herbal supplements you are currently taking
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If you are pregnant, plan to become pregnant, or are breast-feeding
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Use of alcohol or recreational drugs (if applicable)
How should I take Remeron®?
Mirtazapine is usually taken once daily at bedtime with or without food.
While the dose usually ranges from 15 mg to 45 mg, your healthcare provider will determine the dose that is right for you based upon your response.
What happens if I miss a dose of Remeron®?
If you miss a dose of mirtazapine, take it as soon as you remember unless it is close to when your next dose is due. If you missed a dose of medication and it is close to the time of your next dose, skip the missed dose and take your next dose at the regularly scheduled time. Do not double your next dose or take more than your prescribed dose.
What should I avoid while taking Remeron®?
Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications because the beneficial effects of the medication may be decreased and adverse effects may be increased (e.g. sedation, dizziness).
What happens if I overdose with Remeron®?
If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).
Symptoms of overdose include disorientation, drowsiness, memory problems, and fast heart rate. A specific antidote does not exist.
What are the possible side effects of Remeron®?
Side effects with mirtazapine are generally mild and often resolve over the first 1-2 weeks of treatment as you continue to take the medication. The most commonly reported side effects are sedation or drowsiness, but this is usually temporary and goes away within a few days. Other common side effects which may persist include increased appetite, weight gain and increased triglycerides.
Unlike many other popular antidepressants, mirtazapine does not commonly cause sexual dysfunction and may be selected as an alternative treatment when antidepressant-induced sexual dysfunction is problematic. Also, the discontinuation of mirtazapine has not been associated with any withdrawal syndromes, though the decision to stop the medication should always be discussed first with your provider.
Are there any risks for taking Remeron® for long periods of time?
To date, there are no known neurotoxic or permanent side effects associated with long term use of mirtazapine. It is a safe and effective medication when used as directed.
What other drugs may interact with Remeron®?
Mirtazapine should not be taken with or within two weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®) and selegeline (Emsam®).
If you take clonidine for high blood pressure, starting mirtazapine may cause a significant increase in blood pressure.
Although rare, there is an increased risk of serotonin syndrome when mirtazapine is used with other medications that increase serotonin activity such as other antidepressants; migraine medications called “triptans” (e.g. Imitrex®); the analgesics tramadol (Ultram®) or meperidine (Demerol®); and the antibiotic linezolid (Zyvox®).
Always let your doctor know what other prescription, over-the-counter, and herbal medications you are taking.
How long does it take for Remeron® to work?
Disturbances in sleep, energy, or appetite may show some improvement within the first 1-2 weeks and can be an important early signal that the medication is working. Other symptoms such as depressed mood or lack of interest in activities may take 4-6 weeks before improvement is evident.
Updated by
Patrick R. Finley, Pharm.D., BCPP
(February 2009)
NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
For further information please contact the pharmaceutical company listed below.
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Organon
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375 Mt. Pleasant Ave.
West Orange, NJ 07052
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800-631-1253
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www.organon.com
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Free or low-cost medications provided by pharmaceutical companies
Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.
Remeron Rx Assistance Program: 1-800-241-8812
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