Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG).
TAKEDAMelatonin receptor agonist approved for insomnia
Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG). In one study, patients (aged 18–64 y) received a single, nightly dose of ramelteon 8 or 16 mg or matching placebo for 35 days. As determined by PSG on the first 2 nights of Weeks 1, 3, and 5, both doses of ramelteon reduced the average latency to persistent sleep compared with placebo. The second study randomized patients aged 65 years and older to ramelteon 4 or 8 mg or placebo. PSG assessment for 2 consecutive nights in 3 separate study periods determined that ramelteon reduced latency to persistent sleep compared with placebo. Another study of patients aged 65 years and older with chronic insomnia employed sleep diaries to evaluate the efficacy of ramelteon 4 or 8 mg or placebo for 35 nights. Both ramelteon doses reduced patient-reported sleep latency compared with placebo. A randomized, double-blind, parallel-group study using a first-night-effect model evaluated the efficacy of ramelteon in the treatment of transient insomnia. Healthy adults received placebo or ramelteon 8 or 16 mg before spending 1 night in a sleep laboratory being monitored by PSG. The 8-mg dose of ramelteon demonstrated a decrease in mean latency to persistent sleep as compared with placebo.
Safety. Ramelteon should not be used in patients with severe hepatic impairment. As with other hypnotics, exacerbation of insomnia and the emergence of cognitive and behavioral abnormalities were observed with ramelteon during clinical development. Worsening of depression has been reported with the use of hypnotics by primarily depressed patients. Ramelteon should not be used in combination with fluvoxamine and should be administered with caution in patients taking other CYP1A2 inhibitors as well as CYP3A4 inhibitors and CYP29C inhibitors. The most common adverse events associated with ramelteon include headache, somnolence, fatigue, dizziness, nausea, exacerbated insomnia, diarrhea, myalgia, depression, dysgeusia, and arthralgia.
Dosing. Ramelton should be taken as an 8-mg dose within 30 minutes of going to bed. Ramelteon should not be taken with or immediately following a high fat meal.