New Sleep Drug May Be Less Prone to Abuse

THURSDAY, Oct. 5, 2006 (HealthDay News) -- The sleep medication ramelteon (brand name Rozerem), recently approved in the United States to treat insomnia, does not appear to have potential for substance abuse or for motor or cognitive impairment, according to company-funded research.

Currently, sleep medications called benzodiazepine receptor agonists -- which include Xanax, Valium and Halcion -- are commonly used to treat insomnia. But these drugs carry a risk for abuse and can cause problems with cognition (thinking, learning and memory), and motor impairments that may make driving dangerous and increase the risk of falls among older adults, according to background information in the study.

In addition, long-term use of benzodiazepine receptor agonists may lead to withdrawal symptoms -- such as anxiety, irritability and seizures -- when patients stop taking the drugs.

Ramelteon works through a different brain pathway -- one that involves melatonin receptors -- and, therefore, is less likely than benzodiazepine receptor agonists to cause such problems, say researchers at Johns Hopkins University School of Medicine.

The study was funded by Takeda North America, the Japanese pharmaceutical company that makes ramelteon.

The study included 14 patients with histories of abusing sedatives. Over about 18 days, the patients received different doses of: ramelteon (16, 80 or 160 milligrams); the benzodiazepine receptor agonist triazolam/Halcion (0.25, 0.5 or .75 milligrams); and a placebo.

The patients were asked about their responses to the drugs/placebo and were assessed in a number of areas, including cognitive and motor function, and impairment.

In terms of effects on the patients, the study found no differences between the three doses of ramelteon and the placebo.

"In contrast, triazolam showed dose-related effects on a wide range of subject-rated, observer-rated and motor and cognitive measures, consistent with its profile as a sedative drug with abuse liability," the study authors wrote.

They concluded: "Although further clinical trials are warranted, remelteon may be particularly useful for the treatment of insomnia in individuals with a history of substance abuse, in older subjects (who are especially susceptible to the impairing effects of benzodiazepine receptor agonists), and in persons requiring minimal interference with arousal response (e.g., on-call workers and patients with chronic obstructive pulmonary disease). Furthermore, ramelteon may be a safe first-line medication even in individuals not reporting substance abuse, given that some individuals may not admit to such misuse."

The study appears in the October issue of the journal Archives of General Psychiatry.

More information

The Consumer Reports has more on newer sedative drugs.