Next Pharmaceuticals, Inc.
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Proprietary Products
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Seditol<sup>®</sup>
Sleep & Relaxation
Magnolia officinalis Ziziphus jujuba
About Seditol®:

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

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.

Safety

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

animal and human safety data on the individual ingredients and the final combination of ingredients in Seditol®.

Efficacy In Animal Models

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.

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.

Human Trials
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.

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

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:

  • 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

In the most recent open-label human trial with 741 subjects 93% said that Seditol® helped them relax, 88% said

it insured a sound night's sleep, and 89% said Seditol® reduced fatigue due to lack of sleep.

Intellectual Property
Next Pharmaceuticals, Inc. has two patents on the Magnolia portion of Seditol®. US Patent No: US 6,582,735 and US 6,814,987.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.
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Where To Buy Seditol®
Purchase Seditol® Now!

 
Highlights
How Stress Affects Sleep
 
 
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