The recommended dose of ramelteon is 8 mg, taken within 30 minutes of bedtime. Ramelteon should not be taken with, or immediately after, a high-fat meal because of the delay in absorption.
No overall differences in safety or efficacy were observed between elderly and younger adult subjects. In a phase 3 study of elderly patients with chronic insomnia conducted by Roth and colleagues, patients aged 65 to 83 years demonstrated no significant adverse events and no evidence of next-morning psychomotor or memory impairment.
Dosing of ramelteon in this phase 3 study ranged from 4 mg to 8 mg daily.
Hepatically Impaired Patients
In patients with mild hepatic impairment, their exposure to ramelteon was increased by four-fold in comparison with normal subjects. The manufacturer recommends use with caution in patients with mild-to-moderate hepatic impairment. The pharmacokinetic properties of ramelteon have not been evaluated in patients with severe hepatic impairment, and the use of this agent should be avoided in this group.
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Renally Impaired Patients
Because ramelteon is eliminated primarily via hepatic metabolism, no adjustment of the drug is required for patients with renal impairment (a creatinine clearance of 30 mL/minute per 1.73 m2 or less) or for patients who require chronic hemodialysis.
Pregnant and Lactating Patients
Ramelteon has been classified as a Pregnancy Category C drug. No studies have been performed in pregnant or lac-tating women. This agent was a developmental teratogen in rats when it was given in doses near 200 times the recommended human dosage.
Ramelteon is also secreted into the milk of lactating rats. The potential risks and benefits of using this medication in pregnant and lactating women should be carefully considered.
In two small studies, ramelteon was shown to increase prolactin levels in adults, thus possibly playing a role in altering the reproductive axis in developing children or adolescents. Because of potential adverse effects and a lack of available studies, this drug is not indicated for use in pediatric patients.
Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The drug can be prescribed for long-term use.
CONTRAINDICATIONS AND PRECAUTIONS
Ramelteon should not be used in patients with hypersensitivity to any components of the formulation or in patients with severe hepatic impairment. It should not be used in combination with fluvox-amine maleate (Luvox, Solvay), and it should not be taken with alcohol.
Ramelteon has not been studied in patients with severe sleep apnea or severe chronic obstructive lung disease or in pediatric patients.