Silenor

PATIENT INFORMATION

Medication Guide

SILENOR®
(SI-leh-nor)
(doxepin) Tablets

Read this Medication Guide before you start taking SILENOR (doxepin tablets) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about SILENOR (doxepin tablets) ?

After taking SILENOR (doxepin tablets) , you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with SILENOR (doxepin tablets) . Reported activities include:

  • driving a car ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking SILENOR (doxepin tablets) .

Important:

  1. Take SILENOR (doxepin tablets) exactly as prescribed
    • Do not take more SILENOR (doxepin tablets) than prescribed.
    • Take SILENOR (doxepin tablets) 30 minutes before bedtime. After taking SILENOR (doxepin tablets) , you should only do activities needed to get ready for bed.
  2. Do not take SILENOR (doxepin tablets) :
    • with alcohol
    • if you take other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take SILENOR (doxepin tablets) with your other medicines
    • if you cannot get a full night of sleep before you must be active again

What is SILENOR (doxepin tablets) ?

SILENOR (doxepin tablets) is a hypnotic (sleep) medicine that is used to treat people who have trouble staying asleep.

Who should not take SILENOR (doxepin tablets) ?

Do not take SILENOR (doxepin tablets) if you:

  • take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI.
  • have an eye problem called narrow angle glaucoma that is not being treated
  • have trouble urinating
  • are allergic to any of the ingredients in SILENOR (doxepin tablets) . See the end of this Medication Guide for a complete list of ingredients in SILENOR (doxepin tablets) .

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

It is not known if SILENOR (doxepin tablets) is safe and effective in children.

What should I tell my healthcare provider before taking SILENOR (doxepin tablets) ?

Before you take SILENOR (doxepin tablets) , tell your healthcare provider if you:

  • See “Who should not take Silenor (doxepin tablets) ” 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 SILENOR (doxepin tablets) 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. SILENOR (doxepin tablets) 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 SILENOR (doxepin tablets) . You should not breast-feed while taking SILENOR (doxepin tablets) .

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

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

  • a monoamine oxidase inhibitor (MAOI). See “Who should not take SILENOR (doxepin tablets) ?”
  • 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.

How should I take SILENOR (doxepin tablets) ?

  • Take SILENOR (doxepin tablets) exactly as your healthcare provider tells you to take it
  • Your doctor will tell you how many SILENOR (doxepin tablets) to take and when to take them.
  • Your doctor may change your dose if needed.
  • Take SILENOR (doxepin tablets) within 30 minutes of bedtime. After taking SILENOR (doxepin tablets) , you should confine your activities to those necessary to prepare for bed.
  • Do not take SILENOR (doxepin tablets) within 3 hours of a meal. Silenor (doxepin tablets) may not work as well, or may make you sleepy the next day if taken with or right after a meal.
  • Do not take SILENOR (doxepin tablets) unless you are able to get a full night of sleep before you must be active again.
  • Call your doctor 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 SILENOR (doxepin tablets) , call your doctor or get medical help right away.

What should I avoid while taking SILENOR (doxepin tablets) ?

  • You should not drink alcohol while taking SILENOR (doxepin tablets) . Alcohol can increase your chances of getting serious side effects with SILENOR (doxepin tablets) .
  • You should not drive, operate heavy machinery, or do other dangerous activities after SILENOR (doxepin tablets) .

You may still feel drowsy the next day after taking SILENOR (doxepin tablets) . Do not drive or do other dangerous activities after taking SILENOR (doxepin tablets) until you feel fully awake.

What are the possible side effects of SILENOR (doxepin tablets) ?

SILENOR (doxepin tablets) can cause serious side effects including:

  • See “What is the most important information I should know about SILENOR (doxepin tablets) ?”

The most common side effect of SILENOR (doxepin tablets) 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 SILENOR (doxepin tablets) . 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 SILENOR (doxepin tablets) ?

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

General Information about SILENOR (doxepin tablets)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SILENOR (doxepin tablets) for a condition for which it was not prescribed. Do not share SILENOR (doxepin tablets) with other people, even if you think they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SILENOR (doxepin tablets) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SILENOR (doxepin tablets) that is written for healthcare professionals.

For more information, contact Somaxon Pharmaceuticals, Inc. at 1-877-SILENOR (doxepin tablets) (745-3667) visit http://www.silenor (doxepin tablets) .com.

What are the ingredients in SILENOR?

Active Ingredient: doxepin hydrochloride

Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, colloidal anhydrous silica, light anhydrous silicic acid, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No. 1. The 6 mg tablet also contains FD&C Yellow No. 10 and FD&C Blue No. 1.

Last reviewed on RxList: 4/2/2010
This monograph has been modified to include the generic and brand name in many instances.

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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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