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Friday, 21 November, 2008



Sleep Disorder News


Keeping you up to date with the latest clinical trial information

Insomnia

Sleep, Appetite, and Obesity—What Is the Link?
There is a well-documented relationship between short sleep duration and high body mass index (BMI). Insomnia can result in daytime consequences, including tiredness, difficulty concentrating, and irritability, as well as increased healthcare utilization and reduced work productivity, lower quality of life or quality of social relationships, and decrements in memory, mood, or cognitive function.

Short Sleep Duration Is Associated with Reduced Leptin, Elevated Ghrelin, and Increased Body Mass Index
In population studies, a dose-response relationship between short sleep duration and high body mass index (BMI) has been reported across all age groups.

Ramelteon—A Melatonin Receptor Agonist in the Treatment of Insomnia
Insomnia is a common condition characterized by difficulty falling asleep, increased night-time wakefulness or inadequate sleep duration.


Effects of Vitamin B12 on the Body's Internal Clock



Circadian rhythms are 24-hour cycles that influence natural functions in the body such as heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an internal clock and affect sleep patterns. The purpose of this study is to determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

Selected Reading

A Multicentre, Randomised, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Ramelteon Compared to Placebo With Zopiclone as a Reference Arm in Adults With Chronic Insomnia

Randomised, double-blind, double dummy, placebo-controlled, multicentre reference study to examine the effects of ramelteon (TAK-375) on psychomotor and cognitive performance at peak plasma concentration levels and to evaluate the efficacy and safety of ramelteon compared to placebo with zopiclone as a reference arm over 28 consecutive nights in adults diagnosed with chronic insomnia.

Selected Reading

A Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

The study will involve an evaluation of the efficacy and safety of ramelteon (TAK-375) over a 6-month period in adults and elderly subjects with chronic insomnia. The test agent ramelteon will be used at 8 mg fixed dose and the study will be conducted in multiple sites.

Selected Reading
Newly FDA-approved drugs

Ambien CR (zolpidem tartrate) Extended-Release Tablets
Approved: September 2, 2005 Company: Sanofi-aventis
Treatment for: Insomnia
Ambien CR is new extended-release bi-layered tablet formulation of Ambien which delivers the drug in two stages. The first layer dissolves quickly to induce sleep and the second layer is released more gradually into the body to help provide more continuous sleep
Guidelines Watch
A round up of the latest Clinical Guidelines from the National Guideline Clearinghouse (NGC)

Sleep Disorders

Sleep disorders
American Medical Directors Association - Professional Association. 2006. 36 pages. NGC:005027



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