What is the recommended dosing for Ramelteon (Rozerem), a melatonin receptor agonist?

From the Guidelines

Ramelteon should be dosed at 8 mg taken within 30 minutes before bedtime for the treatment of insomnia characterized by difficulty with sleep onset, as recommended by the American Academy of Sleep Medicine 1.

Key Considerations

• The medication should not be taken with or immediately after a high-fat meal as this can reduce its effectiveness.
• Patients should allow for a full 7-8 hours of sleep opportunity after taking ramelteon to avoid morning drowsiness.
• Ramelteon works by selectively binding to melatonin receptors (MT1 and MT2) in the brain, helping to regulate the body's natural sleep-wake cycle.

Important Safety Information

• Unlike many other sleep medications, ramelteon is not a controlled substance and has not been shown to cause dependence or withdrawal symptoms.
• It's essential to avoid alcohol while taking ramelteon as this can increase side effects.
• Common side effects include dizziness, fatigue, and somnolence.
• Patients with severe hepatic impairment should not use ramelteon, and those with moderate impairment should use it with caution.
• The medication is not recommended for patients with severe sleep apnea or severe COPD.

Clinical Guidelines

• The American Academy of Sleep Medicine suggests using ramelteon as a treatment for sleep onset insomnia in adults, based on trials of 8 mg doses 1.
• The guideline also recommends caution when using ramelteon in certain patient populations, such as the elderly and those with compromised respiratory function.

From the FDA Drug Label

2.1 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. The recommended dosing of ramelteon is:

• 8 mg taken within 30 minutes of going to bed
• Not to exceed 8 mg per day
• Should not be taken with or immediately after a high-fat meal 2

From the Research

Ramelteon Dosing Information

• The recommended dose of ramelteon is 8 mg, taken approximately 30 minutes prior to bedtime 3.
• Ramelteon is available as an 8 mg tablet, with no limitation on how long the medication may be prescribed by the FDA 3.
• The efficacy and safety of ramelteon have been demonstrated in short-term and long-term studies, with no evidence of rebound insomnia, withdrawal symptoms, or next-day residual effects 4, 5, 6.
• Ramelteon has been shown to be effective in reducing latency to persistent sleep and improving sleep quality, with significant decreases in sleep onset latency observed at various time points during treatment 4, 5, 6.

Administration and Duration

• Ramelteon should be taken 30 minutes before bedtime, as directed 3, 6.
• The medication has been evaluated in studies of up to 6 months in duration, with consistent reductions in sleep onset latency and no significant next-morning residual effects 6.
• Long-term treatment with ramelteon has been shown to be safe and effective, with no withdrawal symptoms or rebound insomnia upon discontinuation 6.

Special Considerations

• Ramelteon is not scheduled as a controlled substance by the U.S. Drug Enforcement Agency, due to its lack of abuse liability 3.
• The medication has been approved for the treatment of insomnia characterized by difficulty with sleep onset, and may have potential off-label uses for circadian rhythm sleep disorders such as shift-work and jet lag 4.