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Interesting tidbits on Xyrem

Posted by PillowGirl on September 20, 2002 at 18:40:58:

The below info is from orphan's website http://www.orphan.com/ArticleDetail.cfm?ID=285. I have excerpted the parts that I found most interesting.

I am in the trial and concur with the stuff regarding the MWT. At my last sleep study, I did not fall asleep once during any of the MWT tests ( I was out in under 12 min for the non med MWT).

"DATA:
1. Xyrem improved the quality of sleep in narcolepsy patients and caused it to be better integrated.
Xyrem produced a dose-related increase in slow-wave (Stage 3-4) sleep, with a corresponding reduction in Stage 1 sleep. Slow wave sleep is the restorative stage of sleep. Delta power, a derived index of all slow wave signals used in the research of sleep, also showed a highly significant increase across all doses. These changes in the restorative components of sleep were accompanied by a decrease in the number of nocturnal awakenings, reaching statistical significance at the 7.5 and 9-gram doses.

After the first night of dosing, a significant and acute increase in REM sleep was measured in all-night recordings. Over the course of the trial as the time spent in stage 3 and 4 sleep increased, the total time spent in the Rapid Eye Movement (REM) stages of sleep decreased. These changes were accompanied by a decreasing trend in the shifts between sleep stages across the doses, although the total sleep time did not change across the length of the trial.

2. Xyrem works in addition to stimulants that patients take to stay awake
Individuals with narcolepsy typically take stimulants during the day to help with their daytime sleepiness and to reduce uncontrolled sleep attacks. While still taking their standard doses of stimulants, prior to therapy with Xyrem, the narcolepsy patients in the trial showed a strong tendency to fall asleep quite quickly as measured by the Maintenance of Wakefulness Test (MWT). This daytime test is used to measure how quickly a person falls asleep under controlled soporific conditions while trying to stay awake. Improvement as measured by the MWT was seen after 4 weeks of Xyrem dosing at the 4.5-gram dose. Even greater improvement was seen after 10 weeks of treatment, during which the dose was titrated up to 9 grams per night. Moreover, these results, using the objective MWT measure of daytime sleepiness, were consistent with improvements seen in this study and previous Xyrem studies using a subjective measure of daytime somnolence, the Epworth Sleepiness Scale while these patients maintained stable stimulant dosing.

Narcolepsy patients typically enter into REM sleep soon after falling asleep. This abnormal phenomenon is part of the diagnostic profile of narcolepsy. During MWT testing, the number of patients demonstrating sleep-onset REM episodes decreased significantly, suggesting improvement in narcolepsy status. "

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