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Older Adults With Insomnia Report Falling Asleep Faster with Ramelteon

Another new sleep drug fighting for FDA approval focuses on senior citizens

May 12, 2005 – The FDA approval of the sleep-aid Lunesta created excitement among the millions of senior citizens who have problems with sleeping. Now, there is a new drug fighting for approval that has just completed a clinical study focused on older people. Ramelteon, the researchers say, “Significantly reduced time to fall asleep in older adults with chronic insomnia.”

An estimated 60 million people in the U.S. suffer from insomnia, and approximately half of all older adults experience one or more symptoms of insomnia at least a few nights per week.

Takeda Global Research & Development Center announced on September 24, 2004, that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia. Ramelteon, the company says, belongs to a new class of prescription drugs with the first novel mechanism of action to be developed in 35 years in the area of sleep research. Ramelteon specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body's sleep-wake cycle.

Results from the Phase 3 clinical study were presented at the 2005 Annual Scientific Meeting of the American Geriatrics Society and showed that bedtime administration of ramelteon, an investigational compound currently under review for the treatment of insomnia, significantly reduced time to fall asleep in older adults with chronic insomnia. Additionally, no rebound insomnia or withdrawal effects were observed.

"Improving sleep in older adults is a very important health issue. Far too often, older adults and their physicians accept the myth that poor sleep is a fact of life – that it comes with aging," said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit, Mich. "Although it is true that as people age their sleep architecture changes, sleep by no means becomes less significant."

Study Design

A total of 829 older adults (ages 64–93 years) were enrolled in a randomized, double-blind, 5-week study. Participants received bedtime administration of one of three treatments: ramelteon 4 or 8 mg, or placebo. Study participants completed next-morning sleep questionnaires regarding their previous night's sleep for each night during the study.

Analysis of data from the questionnaires showed that, in comparison to those who received placebo, study participants who received ramelteon 4 or 8 mg had statistically significant decreases in estimates of time to fall asleep. In addition, after patients discontinued the use of ramelteon, there was no rebound insomnia, nor did patients exhibit symptoms of withdrawal. The incidence of adverse events for both ramelteon 4 mg and 8 mg dose groups was comparable with that of placebo.

"We are extremely pleased with the results of this study. We think the data, which showed no rebound insomnia or withdrawal effects, are particularly exciting and may add to the potential for ramelteon to provide another option for older adults living with insomnia," said Steve Sainati, MD, PhD, vice president of Clinical Research, Takeda Pharmaceuticals North America, Lincolnshire, Ill.

The clinical research program before the FDA application included more than 4,200 patients, ages 18 to 93, who received single daily doses of ramelteon for various periods of time up to one year. Ramelteon has been studied in clinical trials in the U.S., Japan and Europe. Seven placebo-controlled trials were conducted to determine the efficacy of ramelteon in the treatment of insomnia, and results from 42 ramelteon trials are summarized in the company's safety database. The company's clinical research database also includes interim data from an ongoing, year-long safety study.

In addition, Takeda has conducted animal and human studies to further assess ramelteon's safety attributes. These studies specifically evaluate whether or not treatment with ramelteon has the risk of drug dependence and abuse associated with other FDA-approved drugs for insomnia. Results from the animal abuse liability and addiction studies will be presented at the U.S. Psychiatric and Mental Health Congress later this year.

"We're excited about the continued development of ramelteon. Insomnia is a serious condition that affects the daily lives of millions of Americans, and we believe that there is a significant need for new treatment options that may benefit patients," said Sainati.

The Company Says About Ramelteon

Ramelteon acts via a new mechanism of action, specifically targeting two receptors in the brain, MT1 and MT2. The MT1 and MT2 receptors are located in the brain's suprachiasmatic nuclei (SCN). The SCN is known as the body's "master clock" because it regulates the 24-hour sleep-wake cycle. Together, it is believed the MT1 and MT2 receptors serve as key facilitators of sleep-wake regulation.

Currently prescribed sleep agents and some investigational drugs work by targeting gamma-aminobutyric acid (GABA) receptors, which are located throughout the brain. In pre-clinical studies, ramelteon has shown no affinity for GABA or opiate receptors.

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Il., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes and cholesterol-lowering treatments. Through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

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