What is ramelteon used for?

From the Guidelines

Ramelteon is primarily used to treat insomnia, specifically difficulty falling asleep, and is typically prescribed for adults who have trouble initiating sleep. The recommended dose is 8 mg taken within 30 minutes of bedtime, as indicated in the clinical guideline for the evaluation and management of chronic insomnia in adults 1. It should not be taken with or immediately after a high-fat meal, as this can reduce its effectiveness. Ramelteon works by activating melatonin receptors in the brain, mimicking the effects of the body's natural sleep hormone, which helps regulate the body's internal clock (circadian rhythm) and promote sleep onset 1.

Key Points to Consider

• Unlike many other sleep medications, ramelteon is not habit-forming and doesn't cause next-day drowsiness for most people, making it a safer option for longer-term use compared to some other sleep aids 1.
• Patients should avoid alcohol while taking ramelteon, as it can increase drowsiness, and they should also allow for 7-8 hours of sleep after taking the medication to avoid feeling groggy if waking up earlier.
• The evidence for the efficacy of ramelteon is marginal, but it appears to be greater than the minimal potential harms, with low-quality evidence showing no statistically significant difference between ramelteon and placebo for sleep outcomes in the general population 1.
• A clinical practice guideline suggests that clinicians use ramelteon as a treatment for sleep onset insomnia in adults, with a weak recommendation based on low-quality evidence 1.

Important Considerations for Use

• Ramelteon has a very short half-life and is likely to reduce sleep latency but have little effect on waking after sleep onset (WASO), making it suitable for patients with difficulty initiating sleep 1.
• It is unlikely to result in residual sedation, which is a benefit for patients who need to wake up feeling alert and refreshed.
• The FDA has approved ramelteon for the treatment of insomnia, and it is considered a safe option for adults who have trouble falling asleep, with minimal potential for adverse effects 1.

From the FDA Drug Label

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. Ramelteon is used for the treatment of insomnia characterized by difficulty with sleep onset 2.

• The approved use is for patients who have trouble falling asleep.
• The duration of clinical trials was up to six months.

From the Research

Overview of Ramelteon

Ramelteon is a selective MT(1)/MT(2) melatonin receptor agonist used for the treatment of insomnia characterized by difficulty with sleep onset 3, 4, 5, 6, 7.

Indications and Usage

• Ramelteon is indicated for the treatment of insomnia characterized by difficulty falling asleep 3, 4, 5, 6, 7.
• It is approved by the US Food and Drug Administration (FDA) for this indication 5, 6, 7.
• Ramelteon is available as an 8 mg tablet, taken approximately 30 minutes prior to bedtime 7.

Efficacy

• Ramelteon has been shown to reduce latency to persistent sleep (LPS) and subjective sleep latency (sSL) in patients with chronic insomnia 3, 4, 5, 6.
• Improvements in total sleep time (TST) and sleep efficiency (SE) have also been reported, although these effects may not be consistent across all studies 5, 6.
• Ramelteon's efficacy has been demonstrated in both younger and older adults with insomnia 3, 5.

Safety and Tolerability

• Ramelteon is generally well tolerated, with common adverse events including headache, dizziness, somnolence, fatigue, and nausea 3, 4, 5, 6.
• Ramelteon does not impair next-day cognitive or motor performance and is not associated with withdrawal symptoms, rebound insomnia, or abuse potential 4, 5, 6, 7.
• As a result, ramelteon is not classified as a controlled substance by the US Drug Enforcement Agency 7.