RxPG News Feed for RxPG News

Medical Research Health Special Topics World
  Home
 
   Health
 Aging
 Asian Health
 Events
 Fitness
 Food & Nutrition
 Happiness
 Men's Health
 Mental Health
 Occupational Health
 Parenting
 Public Health
 Sleep Hygiene
 Women's Health
 
   Healthcare
 Africa
 Australia
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 UK
 USA
 World Healthcare
 
   Latest Research
 Aging
 Alternative Medicine
 Anaethesia
 Biochemistry
 Biotechnology
 Cancer
 Cardiology
 Clinical Trials
 Cytology
 Dental
 Dermatology
 Embryology
 Endocrinology
 ENT
 Environment
 Epidemiology
 Gastroenterology
 Genetics
 Gynaecology
 Haematology
 Immunology
 Infectious Diseases
 Medicine
 Metabolism
 Microbiology
 Musculoskeletal
 Nephrology
 Neurosciences
 Obstetrics
 Ophthalmology
 Orthopedics
 Paediatrics
 Pathology
 Pharmacology
  Adrenergics
  Analgesics
  Anti Cancer Drugs
  Anti-Clotting Drugs
  Anti-Inflammatory
  Antibiotics
  Anticholesterol
  Antihypertensives
  Antivirals
  Fatty Acids
  Hypnotics
   Ramelteon
  Metals
  PPI
  Surfactants
  Varenicline
 Physiology
 Physiotherapy
 Psychiatry
 Radiology
 Rheumatology
 Sports Medicine
 Surgery
 Toxicology
 Urology
 
   Medical News
 Awards & Prizes
 Epidemics
 Launch
 Opinion
 Professionals
 
   Special Topics
 Ethics
 Euthanasia
 Evolution
 Feature
 Odd Medical News
 Climate

Last Updated: Oct 11, 2012 - 10:22:56 PM
Ramelteon Channel

subscribe to Ramelteon newsletter
Latest Research : Pharmacology : Hypnotics : Ramelteon

   EMAIL   |   PRINT
FDA Approves Ramelteon, the First 'No Abuse' Drug for Insomnia

Jul 23, 2005 - 11:56:00 PM , Reviewed by: Priya Saxena
"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."

 
[RxPG] 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(TM) (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.



Publication: United States Food and Drug Administration
On the web: www.ROZEREM.com 

Advertise in this space for $10 per month. Contact us today.


Related Ramelteon News
Ramelteon shows less potential to foster abuse and dependence
Ramelteon showed significant reduction in time to fall asleep
FDA Approves Ramelteon, the First 'No Abuse' Drug for Insomnia
FDA approved Ramelteon

Subscribe to Ramelteon Newsletter

Enter your email address:


 Additional information about the news article
For complete prescribing information, please visit www.ROZEREM.com.

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 www.tpna.com.



Contacts:

Jocelyn M. Gerst
Takeda Pharmaceuticals North America
847-383-3696 (office)
847-769-6889 (cell)

Chesha E. Oliver
Ketchum
646-935-4036 (office)
 Feedback
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 
Contact us

RxPG Online

Nerve

 

    Full Text RSS

© All rights reserved by RxPG Medical Solutions Private Limited (India)