ramelteon 8 MG Oral Tablet Rozerem

1 INDICATIONS AND USAGE ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] . ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )

Takeda Pharmaceuticals America, Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] toxicity to various agents` `[3] nausea` `[4] fatigue` `[5] pain` `[6] drug abuse` `[7] diarrhoea` `[8] headache` `[9] off label use` `[10] vomiting`

5 years ago

ROUND ORANGE TAK RAM 8

5 years ago

TAK RAM 8 ROUND ORANGE

16 HOW SUPPLIED/STORAGE AND HANDLING 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.

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Rozerem 8 MG Oral Tablet

Takeda Pharmaceuticals America, Inc.

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