What is the recommended dosage and usage of Rozerem (ramelteon) for treating insomnia?

From the Guidelines

Rozerem (ramelteon) is recommended at a dose of 8 mg taken within 30 minutes before bedtime for the treatment of insomnia, particularly difficulty with sleep onset. This recommendation is based on the most recent and highest quality study available, which suggests that ramelteon is effective for the treatment of sleep onset insomnia with minimal potential harms 1. 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 Rozerem to avoid morning drowsiness.

Key Considerations

• Unlike many sleep medications, Rozerem is not a controlled substance and can be used for long-term management of insomnia without significant risk of dependence.
• It works by selectively targeting melatonin receptors in the brain, specifically the MT1 and MT2 receptors, which help regulate the body's natural sleep-wake cycle.
• This mechanism differs from other sleep medications like benzodiazepines or "Z-drugs" that work on GABA receptors.
• Patients should avoid alcohol while taking Rozerem, as the combination can increase drowsiness.
• Those with severe liver impairment, sleep apnea, or who are taking fluvoxamine should not use Rozerem due to potential complications or drug interactions.

Clinical Guidelines

The American Academy of Sleep Medicine clinical practice guideline suggests that clinicians use ramelteon as a treatment for sleep onset insomnia in adults, based on trials of 8 mg doses of ramelteon 1. Additionally, the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines advise against the use of benzodiazepines and trazodone for the treatment of chronic insomnia disorder, due to their adverse effect profiles and potential risks 1.

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 dosage and usage of Rozerem (ramelteon) for treating insomnia is:

• Dose: 8 mg
• Timing: taken within 30 minutes of going to bed
• Precautions: not to be taken with or immediately after a high-fat meal
• Maximum daily dose: not to exceed 8 mg per day 2

From the Research

Recommended Dosage and Usage of Rozerem (Ramelteon)

The recommended dosage of Rozerem (ramelteon) for treating insomnia is:

• 8 mg tablet, taken approximately 30 minutes prior to bedtime 3
• No limitation on how long the medication may be prescribed 3

Efficacy of Rozerem (Ramelteon)

The efficacy of Rozerem (ramelteon) in treating insomnia is supported by several studies, including:

• A study that found ramelteon 8 mg improved latency to persistent sleep (LPS) at week 1, and this effect was maintained throughout the duration of 5-week and 6-month clinical studies 4
• A pooled analysis of four randomized, double-blind, placebo-controlled clinical trials that found ramelteon 8 mg reduced LPS by approximately 13 minutes more than placebo on nights 1 and 2 of treatment in adults with chronic insomnia 5
• A study that found ramelteon 8 mg significantly reduced subjective sleep latency (sSL) at week 1, and this improvement was sustained at weeks 3 and 5 in older adults with severe baseline sleep-onset difficulties 6

Tolerability and Safety of Rozerem (Ramelteon)

The tolerability and safety of Rozerem (ramelteon) are supported by several studies, including:

• A study that found ramelteon was generally well tolerated, did not impair next-day cognitive or motor performance, and was not associated with withdrawal symptoms, rebound insomnia, or abuse potential 4
• A study that found the most common adverse events observed with ramelteon included headache, dizziness, somnolence, fatigue, and nausea 7
• A study that found the incidence of adverse events was low, with the most commonly reported treatment-emergent adverse events being dizziness, dysgeusia, myalgia, and headache 6