Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Doxepin is not approved for use in pediatric patients <12 years of age. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on doxepin therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

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doxepin
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(DOX e pin)

What is the most important information I should know about doxepin?

Do not use this medication if you are allergic to doxepin, or if you have glaucoma or problems with urination. Do not use doxepin if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take doxepin before the MAO inhibitor has cleared from your body.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What is doxepin?

Doxepin is in a group of drugs called tricyclic antidepressants. Doxepin affects chemicals in the brain that may become unbalanced.

Doxepin is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.

Doxepin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking doxepin?

Do not use this medication if you are allergic to doxepin, or if you have glaucoma or problems with urination. Do not use doxepin if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take doxepin before the MAO inhibitor has cleared from your body.

Before taking doxepin, tell your doctor if you are allergic to any drugs, or if you have:

  • bipolar disorder (manic-depression); or

  • diabetes (doxepin may raise or lower blood sugar).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether doxepin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give doxepin to anyone younger than 18 years old without the advice of a doctor.
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