Rozerem

Indications & Dosage

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INDICATIONS

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

DOSAGE AND ADMINISTRATION

The recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.

ROZEREM should not be used in subjects with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment.

ROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs (see PRECAUTIONS: DRUG INTERACTIONS).

HOW SUPPLIED

ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets, with "TAK" and "RAM-8" printed on one side, in the following quantities:

NDC 64764-805-30............................Bottles of 30
NDC 64764-805-10............................Bottles of 100
NDC 64764-805-50............................Bottles of 500

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Keep container tightly closed and protected from moisture and humidity.

Manufactured by: Takeda Pharmaceutical Company Limited, 540-8645 Osaka, JAPAN. Manufactured in: Takeda Ireland Ltd. Kilruddery, County Wicklow, Republic of Ireland. Marketed by: Takeda Pharmaceuticals America, Inc. One Takeda Parkway, Deerfield, IL 60015. Revised: Apr., 2006. FDA Rev date: 8/15/2005

Brand Name: Rozerem
Generic Name: Ramelteon

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