Ramelteon Tablets

Dosage form: tablet
Drug class:Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

Indications and Usage for Ramelteon Tablets

Ramelteon Tablets are 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)]

Ramelteon Tablets Dosage and Administration

Dosage in Adults

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

The total Ramelteon Tablets dose should not exceed 8 mg per day.

Dosing in Patients with Hepatic Impairment

Ramelteon Tablets are not recommended in patients with severe hepatic impairment. Ramelteon Tablets should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions ( 5.6), Clinical Pharmacology ( 12.4)] .

Administration with Other Medications

Ramelteon Tablets should not be used i...