New study finds that Ramelteon shows potential for circadian phas...( Sandestin Beach Fla. Results from a ne...),Health

Sandestin Beach, Fla. Results from a new study to further explore the mechanistic action of ramelteon suggest it may have the ability to shift the biological circadian rhythm one's natural 24-hour sleep-wake cycle based on a study model designed to examine this potential. Ramelteon has a unique mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour, or circadian rhythms, including the sleep-wake cycle.

"For many people, especially those who need to fall asleep earlier than their normal bed time or travelers entering a new time zone, these changes can create a disruption, confusing their natural 24-hour 'body clock,' which keeps them aligned with their environment," asserted Gary Richardson, senior research scientist at Henry Ford Hospital, Detroit, Mich., and lead author in the study. "This study was designed to look at the potential to help people adjust to this time shift, and shows the need for additional studies on the effects of ramelteon in this area."

According to the study, patients who received ramelteon before they went to bed five hours earlier than their normal bed time experienced an advancement of dim light melatonin secretion offset compared to placebo, a model used to evaluate a circadian phase-shifting effect. The results were presented today at the 10th Biennial Meeting of the Society for Research of Biological Rhythms.

About the Study
This double-blind, placebo-controlled trial was designed to assess the circadian phase-shift potential of ramelteon. The study enrolled 75 healthy adults who were randomized to receive ramelteon (1 mg, 2 mg, 4 mg or 8 mg) or placebo. Patients were housed for six days in a sleep laboratory under constant dim lighting and went to bed five hours earlier than their habitual bedtime. Study drug was given 30 minutes before lights out.

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Contact: David Buckalew
dbuckalew@tpna.com
847-383-3904
Ketchum
22-May-2006

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