Doxepin is a tricyclic antidepressant.

Doxepin capsules and oral concentrate (liquid) are used to treat symptoms of depression and/or anxiety associated with alcoholism, manic depression, or other mental illness.

Doxepin tablets (Silenor) are used to treat insomnia in people who have trouble staying asleep.

This medication guide provides only information about doxepin tablets for insomnia. Doxepin tablets are not for use in treating depression.

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

You should not use this medicine if you are allergic to doxepin, amoxapine, or loxapine, or if you have:

• untreated narrow-angle glaucoma; or
• severe urination problems.

Do not use doxepin if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• sleep apnea (breathing stops during sleep);
• depression, mental illness, or addiction to drugs or alcohol;
• kidney or liver disease;
• glaucoma; or
• urination problems.

Ask your doctor about taking this medicine if you are pregnant. Taking an antidepressant during late pregnancy may cause medical problems in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor's advice.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

You should not breastfeed while using Silenor.

Silenor is not approved for use by anyone younger than 18 years old.

Use Doxepin (Sinequan) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

• unusual thoughts or behavior;
• confusion, hallucinations;
• depressed mood, thoughts about hurting yourself;
• uncontrolled muscle movements;
• a seizure;
• a light-headed feeling, like you might pass out;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• eye pain or redness;
• chest pain;
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• signs of infection--flu-like symptoms, swelling, skin redness, diarrhea, skin sores or white patches, trouble breathing, pain or burning when you urinate.

Common side effects may include:

• drowsiness, tiredness;
• nausea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking Silenor within 3 hours after eating a meal.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.