Calling all insomniacs!

If a drug-free program of healthy sleep patterns, as a result of biofeedback, relaxation, positive thinking, and good habits is not getting you the deep sleep you need and want, there is good news to report this week.

A novel sleep therapy called Rozerem, otherwise known as Ramelteon (its chemical name), has been approved by the U.S. Food & Drug Administration (FDA).

On Friday, July 22nd 2005, Takeda Pharmaceuticals, based in Lincolnshire, Ill., a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., Japan's largest pharmaceutical company, received FDA approval for the first prescription sleep aid created that is not designated as a controlled substance.

The insomnia pill, to be marketed as Rozerem, targets only the part of the brain that regulates sleep. The chemical compound, ramelteon, has a new mechanism that specifically targets the MT1 and MT2 receptors in the brain.

Takeda's therapy induces what is very similar to natural sleep, the drug maker said.

The FDA approval allows doctors to prescribe the 8-milligram tablets for long-term use in adults, Takeda said in a statement.

Rozerem is the first prescription insomnia medication with a novel therapeutic mechanism of action in thirty-five years.

The therapy has shown no evidence of abuse or dependence.

Roland Griffiths, Ph.D., Professor in the departments of Psychiatry and Neuroscience at Johns Hopkins Bayview Medical Center in Baltimore, MD said in May after Takeda's therapy reported proof through clinical trials of no abuse:

In the treatment of insomnia, drug abuse potential is a significant concern to patients as well as to prescribing physicians.

The chronic nature of some types of insomnia may necessitate treatment for an extended period, underscoring the need for sleep medications with little or no abuse potential.

Steve Sainati, MD, PhD, vice president of Clinical Research at Takeda Global Research & Development in Lincolnshire, Illinois said:

Obtaining abuse potential results similar to that of placebo is an important step in establishing a safety profile for ramelteon.

Comparing ramelteon's effects versus a benzodiazepine sedative-hypnotic provides information that is valuable scientifically, as well as clinically relevant.

A Serious Epidemic

Almost a third of adults have trouble sleeping, and about 10 percent have symptoms of daytime impairment that signal true insomnia.

In the U.S. alone, approximately 60 million people suffer from insomnia, yet the vast majority remains undiagnosed and untreated.

Insomnia is characterized by difficulty falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of next-day functioning.

Insomnia has been linked to a variety of health problems, including obesity, diabetes, hypertension, heart disease and depression.

According to the U.S. Surgeon General, nearly $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in productivity.

Sleep Debt Solution

Rozerem joins a list of newer prescription sleep pills that work without many of the side-effect concerns of older agents. It is absorbed rapidly, with median peak concentrations occurring at approximately 3/4 of an hour (the range is 30 - 90 minutes) after fasted oral administration.

This form of therapy has been studied in patients with chronic insomnia, but it has not been studied in patients with severe sleep apnea or COPD (Chronic Obstructive Pulmonary Disease).

In all, 2,082 subjects were studied. 1,253 were younger adults aged 18 to 64 years of age. 829 subjects were over 65.

Dr. Robert Meyer of the Food and Drug Administration explained;

Rozerem is chemically related to the natural hormone melatonin, which helps regulate the body's sleep-wake cycle, and is thought to work by stimulating melatonin receptors in the brain.

"It's another option" for people with the main form of insomnia, difficulty in falling asleep.

By working through a different pathway, it's entirely possible that this might work for some people in ways that the other drugs do not.

Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center in Detroit, Michigan said:

People with insomnia are not only affected by their sleeplessness at night; insomnia's impact is also in how they feel and function the next day.

Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain.

Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover' effects.

Takeda claims its drug works differently from its competitors.

Yasuchika Hasegawa, president and chief operating officer of Takeda, said:

Rozerem represents an exciting new option in sleep medicine that we anticipate can help millions of people who live with sleepless nights and sluggish days.

The approval of Rozerem marks a major milestone for Takeda as we seek to bring innovative therapies to patients in a variety of therapeutic areas.

Rozerem has a unique therapeutic 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.

Studies do not show any sign that Rozerem causes dependence, the reason it was not designated as a controlled substance.

The main warning: Rozerem is metabolized by the liver, so people with liver problems should not take it, Meyer said.

Manufacturer Takeda Pharmaceuticals said Rozerem's price has yet to be revealed.

Some analysts estimate sales of the sleeping pill could reach $535-$890 million (60-100 billion yen) now that the drug has been approved as a non-scheduled drug. If restrictions had been imposed by the FDA, sales could be only half these estimates.

$1 currently equals 112.15 Yen.

Takeda's first new in-house medicine created in the U.S. in six years may also extend its use to treat Alzheimer's disease and other illnesses.

Rozerem will compete with Sanofi-Aventis' Ambien and Sepracor Inc.'s Lunesta.

Rozerem is expected to hit the U.S. marketplace as early as this September.

In Japan and Europe, Takeda's therapeutic drug for insomnia is under phase III clinical trials.

About Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., 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, insomnia, and cholesterol-lowering treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease, and other conditions.

Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

To learn more about the company and its products, visit:

For an excellent explanation as to why we need good sleep, what happens when we don't sleep, the biology of sleep, and complete prescribing information, please visit:

To follow news related to insomnia and company announcements associated with the subject, Rugged Elegance recommends going to the biotech and pharmaceutical portal that does not require a subscription:

Congratulations Takeda!

And congratulations to those people suffering from sleep deprivation. Perhaps now there is a therapy solution that will work for you.

Inspire & Be Inspired.

Here's to healthy, adventuresome, soulful, "good rest with 8-milligrams of help from Takeda" living!

~ Jennifer Carolyn King, Rugged Elegance, LLC