Ramelteon Is Effective for Some Insomnia Patients

By McNamara, Damian | Clinical Psychiatry News, February 2007 | Go to article overview

Ramelteon Is Effective for Some Insomnia Patients


McNamara, Damian, Clinical Psychiatry News


ORLANDO -- Ramelteon is effective for a subset of patients with insomnia, according to a presentation at a psychopharmacology congress sponsored by the Neuroscience Education Institute. In addition, because the agent works on melatonin receptors, a potential off-label use is for patients with shift-work disorder.

Ramelteon (Rozerem, Takeda Pharmaceuticals) targets the melatonin receptors MT1 and MT2. The agent is approximately 10 times more potent than melatonin. Other approved drugs promote sleep by increasing [gamma]-aminobutyric acid (GABA), which is normally released by the suprachiasmatic nucleus in the brain.

"Ramelteon is a very interesting drug. It is the first on the market for sleep that does not work on the GABA system," Dr. Wallace B. Mendelson said. The melatonin receptor agonist is a very short-acting drug with a half-life of 1 to 2 hours. "It is very potent for helping people fall asleep but not as effective for those who wake up early. So it's for a subset of patients."

The Food and Drug Administration approved ramelteon for treatment of insomnia characterized by difficulty with sleep onset. "It is not a DEA classified substance, only a hypnotic without potential for dependence," said Dr. Mendelson, psychopharmacology consultant for many pharmaceutical companies, including Takeda Pharmaceuticals North America Inc.

A delay to peak therapeutic effect is another distinction of ramelteon, compared with benzodiazepines and newer, nonbenzodiazepine GABA agonists such as zolpidem (Ambien, Sanofi-Aventis) or eszopiclone (Lunesta, Sepracor).

"It can take up to a week for full effect, so caution patients that they may not feel tired right away," said Dr. Mendelson, who is also a consultant, an adviser, and on the speakers' bureau for Sanofi-Aventis and Sepracor Inc.

People with shift-work sleep disorder can experience excessive daytime sleepiness because their body rhythm stays the same but the world changes around them, Dr. Mendelson said.

"No one knows why some people are more susceptible to this, except it is harder to adapt to night-time shift work as you get older."

Pharmacotherapy with a sleep aid might be sufficient for a shift worker who complains only of sleepiness or trouble going off to sleep, Dr. …

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