April 28, 2017
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How Supplied


Silenor (doxepin tablets) 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. [see Clinical Studies].


The dose of Silenor (doxepin tablets) should be individualized.

Dosing in Adults

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


Silenor (doxepin tablets) should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Silenor (doxepin tablets) should not be taken within 3 hours of a meal [see CLINICAL PHARMACOLOGY].

The total Silenor (doxepin tablets) dose should not exceed 6 mg per day.


Dosage Forms And Strengths

Silenor (doxepin tablets) is an immediate-release, oval-shaped, tablet for oral administration available in strengths of 3 mg and 6 mg. The tablets are blue (3 mg) or green (6 mg) and are debossed with 3 or 6, respectively, on one side and SP on the other. Silenor (doxepin tablets) tablets are not scored.

Silenor (doxepin tablets) 3 mg tablets are oval shaped, blue, identified with debossed markings of “3” on one side and “SP” on the other, and are supplied as:

NDC 42847-103-30..................Bottle of 30
NDC 42847-103-10..................Bottle of 100
NDC 42847-103-50..................Bottle of 500
NDC 42847-103-03..................Blister trade pack of 30

Silenor (doxepin tablets) 6 mg tablets are oval shaped, green, identified with debossed markings of “6” on one side and “SP” on the other, and are supplied as:

NDC 42847-106-30..................Bottle of 30
NDC 42847-106-10..................Bottle of 100
NDC 42847-106-50..................Bottle of 500
NDC 42847-106-03..................Blister trade pack of 30

Storage and Handling

Store at controlled room temperature 20° - 25°C (68° - 77°F), protected from light.

Manufactured for: Somaxon Pharmaceuticals, Inc. San Diego, CA 92130 USA.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/26/2016

How Supplied

Silenor - User Reviews

Silenor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Silenor sorted by most helpful. Patient Discussions FAQs

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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