Rozerem (Ramelteon) - Indications and Dosage

INDICATIONS AND USAGE

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.

Rx only

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.
475 Half Day Road
Lincolnshire, IL 60069

ROZEREM™ is a trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.

©2005, Takeda Pharmaceuticals America, Inc.

05-1118