Silenor

INDICATIONS

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].

DOSAGE AND ADMINISTRATION

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.

Administration

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.

HOW SUPPLIED

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.

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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