Doxepin is a prescription sleep medicine that is used to treat people with insomnia who have trouble staying asleep.

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Doxepin should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. If you are on a monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the past two weeks, you should not take Doxepin. You should not take Doxepin if you have an eye problem called narrow angle glaucoma that is not being treated, if you have severe urinary retention, or if you are allergic to any of the ingredients in Doxepin. You should not drive or operate machinery at night after taking Doxepin. Until you know how you will react to Doxepin, you should be careful in performing such activities during the day following taking Doxepin. Before you take Doxepin, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Doxepin you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

It is not known if Doxepin is safe and effective in children.

What should I tell my healthcare provider before taking Doxepin?

Before you take Doxepin, tell your healthcare provider if you:

• See “Who should not take Doxepin?”
• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions
• Are pregnant or plan to become pregnant. It is not known if Doxepin will harm your unborn baby.
• Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Are breast-feeding or plan to breast-feed. Doxepin can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Doxepin.
• You should not breast-feed while taking Doxepin.
• Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Doxepin and other medicines may affect each other causing side effects. Doxepin may affect the way other medicines work, and other medicines may affects how Doxepin works. Especially tell your healthcare provider if you take:

• A monoamine oxidase inhibitor (MAOI).

Who should not take Doxepin?

You should not take Doxepin if you take:

• Cimetidine (Tagamet) or other medicines that can affect certain liver enzymes.
• Certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing.
• The diabetes medicine tolazamide.
• Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Doxepin for a condition for which it was not prescribed. Do not share Doxepin with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

SILENOR® is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

DOSAGE AND ADMINISTRATION

The dose of SILENOR® should be individualized.

Dosing In Adults

The recommended dose of SILENOR® for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

Dosing In The Elderly

The recommended starting dose of SILENOR® in elderly patients (≥ 65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

Administration

SILENOR® should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, SILENOR® should not be taken within 3 hours of a meal.

The total SILENOR® dose should not exceed 6 mg per day.

How should I take Doxepin?

• Take Doxepin exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many Doxepin to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Doxepin within 30 minutes of bedtime. After taking Doxepin, you should confine your activities to those necessary to prepare for bed.
• Do not take Doxepin within 3 hours of a meal. Doxepin may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Doxepin unless you are able to get a full night of sleep before you must be active again.
• Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much Doxepin, call your healthcare provider or get medical help right away.

What should I avoid while taking Doxepin?

• You should not drink alcohol while taking Doxepin. Alcohol can increase your chances of getting serious side effects with Doxepin.
• You should not drive, operate heavy machinery, or do other dangerous activities after Doxepin.
• You may still feel drowsy the next day after taking Doxepin. Do not drive or do other dangerous activities after taking Doxepin until you feel fully awake.

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

• The most common side effect of Doxepin is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Doxepin. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Doxepin?

• Store Doxepin between 68° and 77°F (20° to 25°C).
• Keep Doxepin in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.
• Keep Doxepin and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.