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ROZEREM (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Dosage in Adults
The recommended dose of ROZEREM (ramelteon) is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM (ramelteon) not be taken with or immediately after a high-fat meal.
The total ROZEREM (ramelteon) dose should not exceed 8 mg per day.
Dosing in Patients with Hepatic Impairment
ROZEREM (ramelteon) is not recommended in patients with severe hepatic impairment. ROZEREM (ramelteon) should be used with caution in patients with moderate hepatic impairment [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Administration with Other Medications
ROZEREM (ramelteon) should not be used in combination with fluvoxamine. ROZEREM (ramelteon) should be used with caution in patients taking other CYP1A2 inhibiting drugs [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
ROZEREM (ramelteon) is available in an 8 mg strength tablet for oral administration.
ROZEREM (ramelteon) 8 mg tablets are round, pale orange-yellow, film-coated, with “TAK” and “RAM-8” printed on one side.
Storage And Handling
ROZEREM (ramelteon) 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.
Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: 11/10This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/14/2010
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