What is the use of Rozerem (Ramelteon)?

From the Guidelines

Rozerem (ramelteon) is recommended as a treatment for sleep onset insomnia in adults, with a suggested dose of 8 mg taken within 30 minutes before bedtime, due to its unique mechanism of targeting melatonin receptors and lower risk of dependence, tolerance, and withdrawal, as suggested by the American Academy of Sleep Medicine clinical practice guideline 1.

Key Points

• Rozerem works by mimicking the natural sleep hormone melatonin, rather than acting on GABA receptors like benzodiazepines and "Z-drugs" 1.
• The medication has a lower risk of dependence, tolerance, and withdrawal compared to other sleep medications 1.
• Common side effects include dizziness, fatigue, and nausea, and patients should avoid alcohol while taking Rozerem and dedicate 7-8 hours to sleep 1.
• Rozerem should not be used by people with severe liver disease or those taking fluvoxamine, and it typically begins working within a week, though some patients may need to take it for longer to experience full benefits 1.

Comparison to Other Treatments

• 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.
• Other treatments, such as eszopiclone, zaleplon, and zolpidem, are also suggested as treatments for sleep onset and sleep maintenance insomnia, but with different dosages and recommendations 1.
• Melatonin, L-tryptophan, and valerian are not recommended as treatments for sleep onset or sleep maintenance insomnia due to insufficient evidence or lack of effectiveness 1.

From the FDA Drug Label

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The primary use of Rozerem (ramelteon) is for the treatment of insomnia with difficulty falling asleep.

• Key indication: sleep onset insomnia
• Study duration: up to six months 2

From the Research

Overview of Rozerem

• Rozerem, also known as ramelteon, is a melatonin receptor agonist used for the treatment of insomnia characterized by difficulty falling asleep 3, 4, 5, 6.
• It is not classified as a controlled substance and is generally well tolerated, with no evidence of cognitive impairment, rebound insomnia, withdrawal effects, or abuse potential 3, 4, 5, 6.

Efficacy of Rozerem

• Studies have shown that ramelteon can improve latency to persistent sleep (LPS) and total sleep time (TST) in patients with insomnia 3, 4, 6.
• A meta-analysis of 13 trials found that ramelteon was associated with reduced subjective sleep latency (sSL) and improved sleep quality, but was not associated with increased subjective total sleep time (sTST) 6.
• Ramelteon has also been shown to improve sleep efficiency (SE) and reduce the number of nighttime awakenings (NAW) 4, 6.

Safety and Tolerability of Rozerem

• The most common adverse events observed with ramelteon include headache, dizziness, somnolence, fatigue, and nausea 4, 6.
• Ramelteon has been found to be safe and well tolerated, with no evidence of cognitive or psychomotor impairment 3, 5.
• Long-term safety studies are needed to fully establish the safety profile of ramelteon 5, 7.

Comparison with Other Treatments

• Ramelteon has been compared to other sedative-hypnotic agents, but its efficacy relative to other therapeutic options for insomnia is not yet fully established 4.
• Melatonin and its analogs, including ramelteon, may offer a safer alternative to benzodiazepine sedative-hypnotic drugs, which can have adverse effects such as next-day hangover and dependence 7.