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FDA Approves Rozerem (Ramelteon), Non-Scheduled Prescription Sleep Medication

LINCOLNSHIRE, IL -- July 25, 2005 -- Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Rozerem™ (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe Rozerem for long-term use in adults.

Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and will be available for patients by late September.

"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," said Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center, Detroit, Mich. "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."

"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," said Yasuchika Hasegawa, president and chief operating officer of Takeda. "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.

The Rozerem NDA, submitted in September 2004 by Takeda Global Research & Development Center, Inc., was based on data collected from an extensive clinical research program, including recently completed clinical studies with more than 4,200 patients ages 18 to 93. In one study, 472 patients received single daily doses of Rozerem for up to one year. Also, based on recently presented clinical trials, Rozerem has been shown to be safe for older adults, as well as those who have mild-to-moderate chronic obstructive pulmonary disease (COPD) and mild-to-moderate sleep apnea.

About Insomnia
Approximately 60 million people in the United States 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.

About Rozerem
Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem should not be used in patients with hypersensitivity to ramelteon or any components of the formulation. Rozerem can be prescribed for long-term use. However, failure of insomnia to remit after a reasonable period of time, worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities after taking Rozerem should be evaluated, as such symptoms may be the result of an unrecognized underlying medical disorder. In primarily depressed patients, worsening of depression, including suicidal ideation, has been reported in association with the use of hypnotics.

Rozerem should not be used by patients with severe hepatic impairment, or in patients in combination with fluvoxamine.

Rozerem has not been studied in subjects with severe sleep apnea or severe COPD and is not recommended for use in those populations. Patients should be advised to exercise caution if they consume alcohol in combination with Rozerem.

Rozerem has been associated with decreased testosterone levels and increased prolactin levels. As a result, healthcare professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. Rozerem has not been studied in children or adolescents, and the effects in these populations are unknown.

Rozerem should be taken within 30 minutes before going to bed and activities should be confined to those necessary to prepare for bed. Rozerem should not be taken with or immediately after a high-fat meal. Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.

The most common adverse events seen with Rozerem that had greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue.

For complete prescribing information, please visit http://www.Rozerem.com.


SOURCE: Takeda Pharmaceuticals North America, Inc.

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