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About Seditol®:
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Seditol® is an all-natural blend of a patented extract from Magnolia
officinalis (U.S. Patent No. 6,814,987) and a proprietary extract from Ziziphus spinosa. In central nervous system
receptor binding assays, one of the ingredients in Seditol® binds to several important
targets associated with drowsiness, including adenosine A1 and GABA.
A recent study at the Sleep Research and Treatment Center, Department of Psychiatry,
Pennsylvania State University College of Medicine has demonstrated that the
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leading cause of sleeplessness in otherwise healthy adults is an overactive central nervous
system with associated elevation of stress hormones. The scientists
concluded from this study that the therapeutic goal in sleeplessness should be to
decrease the level of physical and emotional arousal, and not just improve nighttime
sleep. Seditol® was developed to uniquely address the need to decrease nighttime
physical and emotional arousal while providing a feeling of relaxation and less worry.
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Safety
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Next has an extensive safety file on the ingredients in Seditol®. This data is
gathered from the literature on the individual ingredients in Seditol®, along with Next's
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animal and human safety data on the individual ingredients and the
final combination of ingredients in Seditol®.
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Efficacy In Animal Models
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The Magnolia extract in Seditol® has been shown by Next to be an effective
anxiolytic in an animal model known as the "Chick Social Separation-Stress Procedure."
The paper describing this work was published in the Journal of Psychopharmacology. Stress/anxiety
on a chronic basis leads to an over active hypothalamic-pituitary-adrenal
axis with subsequent hypersecretion of ACTH and cortisol. This excess ACTH and cortisol
have now been correlated with sleeplessness. Other work on Magnolia has clearly demonstrated
its anti-stress and muscle relaxant properties.
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To complement the anti-stress, muscle relaxant properties of the patented Magnolia
extract in Seditol®, Next developed a proprietary extract of Ziziphus spinosa that has
been shown to prolong the hexobarbital sleeping time in mice. Ziziphus is a traditional
plant used as a sedative in traditional Chinese medicine for more than 2,000 years. This
unique combination of an extract to lower stress and induce relaxation along with an
extract for mild sedation has resulted in a safe and effective natural ingredient for
occasional sleeplessness.
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Human Trials
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Next's Magnolia extract in Seditol®; was tested in fifty subjects for two weeks by an
independent contract research organization. 3 out of 4 subjects had restful sleep.
Another 50-subject study utilizing the final formulation of Seditol® with the proprietary
Ziziphus sedative was completed in August 2004.
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The subjects that took Seditol® as directed reported the following results:
- 83% Said Seditol® helps insure a sound night's sleep
- 87% Said Seditol® helps you relax
- 87% Said Seditol® reduces fatigue due to lack of sleep
- 87% said Seditol® allows you to wake up feeling refreshed
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A second 45-person study utilizing Seditol® was conducted by an independent research
organization in March 2005. The subjects in this study reported the following results:
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- 91% said Seditol® helps ensure a sound night's sleep
- 89% said Seditol® allows you to wake up feeling refreshed
- 91% said Seditol® reduces fatigue due to lack of sleep
- 96% said Seditol® is gentle to your stomach
- 84% said Seditol® gives them more energy during the day
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In the most recent open-label human trial with 741 subjects 93% said that Seditol®
helped them relax, 88% said
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it insured a sound night's sleep, and 89% said Seditol®
reduced fatigue due to lack of sleep.
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Intellectual Property
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Next Pharmaceuticals, Inc. has two patents on the Magnolia portion of Seditol®.
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US Patent No: US 6,582,735 and US 6,814,987.
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These statements have not been evaluated by the Food and Drug Administration.
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This product is not intended to diagnose, treat, cure, or prevent disease.
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