Medical and Pharmacy Editor:
Jay W. Marks, MD
GENERIC NAME: mirtazapine
BRAND NAME: Remeron
DRUG CLASS AND MECHANISM: Mirtazapine is in a class of medications
called tetracyclic antidepressants that includes maprotiline (Ludiomil).
Although the precise mechanism of action of this class of antidepressants is not
known, they increase the amount of norepinephrine and serotonin in the brain.
Norepinephrine and serotonin are neurotransmitters, chemicals that nerves use to
communicate with each other. Mirtazapine also acts as an antihistamine similar
to diphenhydramine (Benadryl). Mirtazapine was approved by the FDA in 1996.
GENERIC AVAILABLE: Yes
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 7.5, 15, 30, and 45 mg
STORAGE: Tablets should be stored at room temperature, 15-30°C (59-86°F).
PRESCRIBED FOR: Mirtazapine is used for the treatment of major depression.
DOSING: The usual starting dose for mirtazapine is 15 mg once daily, usually
at bedtime. Doses may be increased every 1-2 weeks up to a maximum dose of 45 mg
daily. It may be taken with or without food.
DRUG INTERACTIONS: Mirtazapine adds to the sedating effects of alcohol and
other drugs that can cause sedation such as the benzodiazepine class of
anti-anxiety drugs (e.g., Valium, Ativan, Klonopin, Xanax), the narcotic class
of pain medications and its derivatives (e.g., Percocet, Vicodin, Dilaudid,
Codeine, Darvon), the tricyclic class of antidepressants (e.g., Elavil,
Tofranil, Norpramin), certain antihypertensive medications (e.g., Catapres,
Inderal), and some antihistamines (e.g., Benadryl; Atarax; Vistaril).
Fluvoxamine (Luvox) may increase the levels of mirtazapine in the blood which
may lead to increased side effects from mirtazapine.
Because of the possibility of developing an increased body temperature
(hyperpyrexia), high blood pressure, or seizures, use of mirtazapine is not
recommended together with monoamine oxidase inhibitors (MAO's), such as
furazolidone (Furoxone), phenelzine (Nardil), procarbazine (Matulane),
selegiline (Carbex), or tranylcypromine (Parnate). An interval of 14 days is
recommended between stopping MAO inhibitor therapy and starting mirtazapine and
vice versa.
PREGNANCY: There are no
adequate studies of mirtazapine in pregnant women .
Thus, physicians must balance potential benefits against potential risks when
considering mirtazapine therapy in pregnant women.
NURSING MOTHERS: It is not known if mirtazapine is secreted in breast milk.
SIDE EFFECTS: Approximately half of the patients who take mirtazapine develop
sleepiness. For this reason, it usually is taken at bedtime. In clinical trials,
about 1 in 10 persons had to stop therapy because of this side effect. About 1
in 14 persons develop dizziness, and 1 in 6 develop an increase in appetite.
Some persons experience weight gain, sometimes requiring discontinuation of
treatment. Mirtazapine may increase blood levels of cholesterol and
triglycerides. One in four persons develops a dry mouth.
If antidepressants are discontinued abruptly, withdrawal symptoms such as
dizziness, headache, nausea, changes in mood may occur. Such symptoms may occur
when even a few doses of antidepressant are missed. Therefore, it is recommended
that the dose of antidepressant be reduced gradually when therapy is
discontinued. Antidepressants may increase the risk of suicide in children and
adolescents. There are concerns that antidepressants may also induce suicide in
adults. Patients with major depression may experience worsening of depression or
suicidal thoughts regardless of whether or not they are treated. Therefore,
patients started on antidepressants should be closely observed for signs of
worsening, suicidal thinking or change in behavior.
Last Editorial Review: 2/22/2006
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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