Rozerem (ramelteon), a new hypnotic medication that is "indicated for the treatment of insomnia characterized by difficulty with sleep onset," was approved by the U.S. Food and Drug Administration (FDA) last Friday (July 22). Because of its unique characteristics, ramelteon is considered to be the first of a new class of sleep aids.
In clinical trials conducted with 4,200 patients, most with chronic insomnia, researchers for Takeda Pharmaceuticals North America were able to demonstrate that ramelteon reduced the time to fall asleep and resulted in a modest increase in total sleep time of patients, but did not decrease nocturnal awakenings, a significant factor for persons whose insomnia causes them to have frequent or prolonged awakenings during the night. 472 patients took ramelteon nightly for one year. After cessation, ramelteon did not cause “rebound insomnia,” a worsening of symptoms that can occur after treatment is halted.
Unlike other prescription sleep aids, ramelteon is thought to work by selectively affecting melatonin receptors (neurons) in the suprachiasmatic nucleus, a part of the brain that functions to regulate times for sleep and times for optimal alertness or wakefulness. This contrasts with other hypnotic medications that work by binding to GABA receptors, which reduce central nervous system (CNS) activity.
Other studies found no evidence that ramelteon has a potential for abuse or dependence. As a result, ramelteon has not been designated as a scheduled substance by the U.S. Drug Enforcement Administration (DEA), the first prescription sleep aid to not be controlled. Additionally, the FDA will allow physicians to prescribe ramelteon for long-term use in adults.
Like other medications, ramelteon does come with precautions. Its use should be preceded by a thorough health evaluation and consideration of alternatives. Labeling information should be read and discussed with a physician or pharmacist to learn about drug interactions and side effects. To date, the effectiveness of ramelteon has not been studied in patients with severe sleep apnea or COPD, nor was it compared in clinical trials to cognitive behavioral therapy, a non-pharmacological treatment method that was identified by a recent National Institutes of Health "State of the Science" panel as effective for treatment of chronic insomnia. Ramelteon is not recommended for use during pregnancy, during nursing or for pediatric use.
From the National Sleep Foundation
As the first non-addictive, non-controlled hypnotic approved by the FDA, Ramelteon should be a popular drug.