Silenor is a tricyclic antidepressant.

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

This medication guide provides information about the Silenor brand of doxepin used to treat insomnia. Sinequan and other generic brands of doxepin used to treat depression or anxiety are not covered in this medication guide. Silenor tablets are not for use in treating depression.

You should not use Silenor if you have untreated narrow-angle glaucoma or severe problems with urination.

Do not use doxepin if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Silenor and talk with your doctor.

Before taking this medicine

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

• untreated narrow-angle glaucoma; or

• severe urination problems.

Do not use Silenor 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.

To make sure Silenor is safe for you, 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 Silenor 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.

Take Silenor exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take this medicine within 30 minutes before bedtime. Do not take within 3 hours after eating.

It may take 7 to 10 days before your insomnia symptoms improve. Keep using as directed and call your doctor if your symptoms do not improve after 10 days of treatment.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

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

• untreated narrow-angle glaucoma; or

• severe urination problems.

Do not use Silenor 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.

To make sure Silenor is safe for you, 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 Silenor 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Do not take Silenor if you do not have time for a full night's sleep before being active again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of doxepin can be fatal.

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.

Get emergency medical help if you have signs of an allergic reaction to Silenor: 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 Silenor 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.

Using Silenor with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• cimetidine (Tagamet); or

• tolazamide (Tolinase).

This list is not complete. Other drugs may interact with doxepin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.