XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
  Depression
  Neuropsychiatry
  Personality Disorders
  Bulimia
  Anxiety
  Substance Abuse
  Suicide
  CFS
  Psychoses
  Child Psychiatry
  Learning-Disabilities
  Psychology
  Forensic Psychiatry
  Mood Disorders
  Sleep Disorders
   Circardian Rhythm
  Peri-Natal Psychiatry
  Psychotherapy
  Anorexia Nervosa
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Nov 17th, 2006 - 22:35:04
Research Article
2005 American Psychiatric Association Annual Meeting

Sleep Disorders Channel
subscribe to Sleep Disorders newsletter

Latest Research : Psychiatry : Sleep Disorders

   DISCUSS   |   EMAIL   |   PRINT
Ramelteon demonstrates no abuse potential
May 24, 2005, 12:42, Reviewed by: Dr.

"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."

 
Results of a clinical study indicated that ramelteon, an investigational compound currently under review by the FDA for insomnia treatment, had no more potential for abuse than placebo in individuals with a history of polydrug abuse. These results, presented at the 2005 American Psychiatric Association Annual Meeting, showed that patients exhibited no abuse potential or behavioral impairment at up to 20 times the proposed therapeutic dose of ramelteon compared to placebo.

"In the treatment of insomnia, drug abuse potential is a significant concern to patients as well as to prescribing physicians," said Roland Griffiths, PhD, Professor in the departments of Psychiatry and Neuroscience, Johns Hopkins Bayview Medical Center, Baltimore, MD. "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."

It is estimated that 60 million Americans suffer from insomnia at least a few nights per week. Most 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.

This study was a placebo-controlled, crossover clinical study of fourteen adults with a history of polydrug or multiple-drug abuse. These subjects were entered into a 7-day double-blind treatment period, comparing behavioral effects and abuse potential of ramelteon and triazolam, a benzodiazepine sedative-hypnotic.

During the treatment period, study medication was administered to patients in a randomly-assigned sequence and included:

* ramelteon (16 mg, 80 mg, 160 mg);
* triazolam (0.25 mg, 0.50 mg, 0.75 mg); and,
* placebo.

Measures of "drug-liking," were assessed each day using questionnaires completed at intervals between 0.5 hours pre-dose, up to 24 hours after dose administration. Memory, reaction time and standing balance tasks were also performed at each of these time intervals. Analysis of peak drug-liking scores showed a dose-response effect in patients receiving triazolam, with significantly greater peak liking reported at the higher doses (0.50 mg, 0.75 mg) as compared with placebo. Ramelteon showed no statistically significant dose-related effect compared to placebo.

Results also showed that triazolam treatment (0.50 mg, 0.75 mg) produced a dose related impairment of task performance as compared to that of placebo. Ramelteon did not produce any significant changes in task performance comparative to that of placebo at any dose.

"Obtaining abuse potential results similar to that of placebo is an important step in establishing a safety profile for ramelteon," said Steve Sainati, MD, PhD, vice president of Clinical Research, Takeda Global Research & Development, Lincolnshire, Ill. "Comparing ramelteon's effects versus a benzodiazepine sedative-hypnotic provides information that is valuable scientifically, as well as clinically relevant."

Ramelteon offers a completely 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.
 

- 2005 American Psychiatric Association Annual Meeting
 

www.tpna.com

 
Subscribe to Sleep Disorders Newsletter
E-mail Address:

 

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 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. To learn more about the company and its products, visit www.tpna.com


Related Sleep Disorders News

Risk Factors For Developing Complications From Sleep Apnea Surgery
Studying sleep deprivation's effect on decisions
New sleep gene discovery wakes up scientists
Diphenhydramine Does Not Improve Infant Sleep
People sleep even less than they think
Computer models may reveal what makes human body clock tick
New fruit fly protein JET illuminates circadian response to light
CBT More Effective Than Zopiclone in Insomnia
Severe hot flashes associated with chronic insomnia
Acting out vivid dreams may forewarn of more serious illness


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

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us