Sereno, The Center for Snoring Solutions, Educates the Public During National Sleep Awareness Week(R)-

Introduced by the National Sleep Foundation (NSF) to educate the public about the importance of sleep to both health and lifestyle, National Sleep Awareness Week® is March 7-13, 2010.  

One very common, but major detriment to adequate, high quality sleep is snoring.  NSF research suggests that:

• Approximately 90 million Americans suffer from snoring
• 23% of couples sleep apart because of snoring
• A substantial percentage of couples are too tired or fatigued for a normal sex life

Historically, snoring has been considered an inconvenience rather than a serious medical condition. That perception is rapidly changing. The effects of sleep loss caused by snoring include fatigue, lack of focus and productivity.  But more importantly, research now indicates a strong link between loss of sleep and medical conditions such as stroke, heart attack, diabetes and hypertension.  Snoring can also have a significant lifestyle impact on couples, and can be a cause of tension or resentment in a marriage or relationship.

SERENO, THE CENTER FOR SNORING SOLUTIONS, a new medical practice based in San Francisco, offers leading-edge, medically proven treatments for snoring in a confidential, professional environment.  

Dr. Matthew Mingrone, medical director of Sereno and a board-certified Otolaryngologist, is a specialist in the treatment of snoring and sleep apnea.  According to Dr. Mingrone, "Snoring treatments now available are safe, minimally invasive, simple, and potentially life-changing.   Sereno is ground-breaking in its unique, patient-centered, and highly effective approach to improving the lives of snorers.  We understand and treat this area of medicine specifically, and far more comprehensively than would be undertaken by a traditional medical practice.   Sereno is the premier practice in the United States dedicated entirely to the treatment of snoring and mild to moderate sleep apnea."

A recent Sereno patient had the following to say about his treatment, "The level of excellence from pre-patient to post-patient care to results far exceeded my cautious optimism.  Last night was the first time since childhood that I didn't snore during a night's sleep.   I, along with my father, underwent the minimally invasive procedure to reduce/cure snoring. Our significant others, the true beneficiaries, have been thrilled with the results. Clearly, I'm a believer and so is my father. We recommend this procedure for all our fellow snorers."

Dr. Matthew Mingrone has extensive experience treating snoring and obstructive sleep apnea and has worked with hundreds of patients whose snoring has had an impact on their marriages, relationships, work, quality of life, and general health.  Using FDA-approved, minimally invasive procedures, which are virtually painless, Dr. Mingrone makes a positive difference in the lives of his patients.  "We recognize the other health issues associated with lack of sleep caused by snoring.  While each patient needs to be individually evaluated, we can make a substantial improvement to the condition in most people. Two things are certain: Snoring is nothing to be ashamed of.  And snoring is definitely not funny."

Visit www.serenocenter.com to learn more.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today an update on its plans to seek U.S. Food and Drug Administration (FDA) approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.  Transcept met with the FDA on January 20, 2010 to discuss the Complete Response Letter (CRL) dated October 28, 2009, and received the official FDA minutes of this meeting on February 19, 2010.  Subsequent to the meeting, Transcept submitted a revised proposal for the resubmission of the Intermezzo® New Drug Application (NDA) to the FDA for evaluation and comment.

October 28, 2009 Complete Response Letter

As previously announced, the FDA stated in the CRL that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.  However, the FDA indicated that the intended use of Intermezzo® in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established, and that the Intermezzo® NDA could not be approved in its present form.

The FDA further recognized that the Intermezzo® data submitted by Transcept did not indicate next day residual effects significantly different from placebo.  However, the FDA requested additional data demonstrating that Intermezzo®, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.  

The FDA expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects, with particular reference to next day driving ability.  Specifically, the FDA asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining and inadvertent re-dosing in a single night.  

Redesigned Packaging and Patient Instructions

In the briefing document submitted prior to the January 20, 2010 meeting, Transcept proposed a new Intermezzo® bedside unit-dose package and patient instructions designed to reduce the possibility of patient dosing errors.  In the meeting minutes, the FDA indicated that the revised packaging appeared to reduce the potential for inadvertently taking more than one dose in a single night.  However, the FDA expressed a remaining concern that the revised packaging may not adequately address the risk of dosing with less than four hours of time remaining in bed, with particular regard to the possibility of impaired driving.

Transcept and the FDA also reviewed the types of data that could support the evaluation of the proposed packaging and instructions, including data from pre-approval assessments of patient understanding of dosing instructions and a potential patient use study of the new Intermezzo® packaging.  As requested by the FDA, Transcept has provided information on the challenges and limitations of pre-approval patient use studies, and has submitted a plan to assess and optimize patient understanding of the new packaging and patient instructions.

Intermezzo® Safety Profile Characterization

To further understand the safety of dosing Intermezzo® in the middle of the night, Transcept has proposed to the FDA to conduct a pre-approval highway driving study to assess the effect of Intermezzo® on driving ability beginning at approximately three hours and four hours post-dosing.  Transcept has also submitted additional supportive analyses of data from a previously conducted Intermezzo® pharmacokinetic and pharmacodynamic study at time points up to four hours post-dosing.  Results from this study were published in a 2008 article titled "Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose sublingual transmucosal zolpidem hemitartrate" in the journal Human Psychopharmacology, an abstract of which is publicly available at www.interscience.wiley.com.

FDA Review of Transcept Post-Meeting Proposals

In the meeting on January 20, 2010, the FDA agreed to review the revised proposal for the Intermezzo® NDA resubmission and consider its adequacy to support the potential approval of Intermezzo®.  The FDA has not set a date for the completion of its review of this proposal or the timing of its response to Transcept.  Transcept plans to provide an update on the Intermezzo® development program, as appropriate, after it receives the results of the FDA's review of the revised proposal.  

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "We are encouraged by the progress made in our recent interactions with the FDA, and appreciate the FDA's willingness to engage in a collaborative dialogue in order to help define the steps necessary for us to resubmit the Intermezzo® NDA."

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. In October 2009, Transcept received a Complete Response Letter from the FDA on the Intermezzo® NDA and is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. For further information, please visit the company's website at: www.transcept.com.

 Sleep to Live®, a division of sleep industry leader Kingsdown, unveiled its latest technology and upgraded state-of-the-art diagnostics process at Las Vegas Market.

The Sleep to Live diagnostics system includes a patented diagnostic sleep-profiling process which collects data through hundreds of sensors that perform 18 statistical measurements and more than 1,000 calculations. The diagnostics system is a comprehensive instrument for personalized sleep measurement and management. Upgrades to the computer program, which guarantees that each Sleep to Live mattress is a custom experience, were introduced to ensure customers get a precise personalized profile.

In addition, Sleep to Live has added My Side Technology® for customers with sleep partners. This unique system provides My Side support zones to correspond to each person's body type. The diagnostic system measures each partner to provide postural support to both unique body types, eliminating sleep partner disturbance, which is caused by an individual's sleep companion's movement and motion.

Along with making the at-home experience better for its customers, Sleep to Live has enhanced the in-store experience by providing three specialized consumer experiences. Working with our retail partners, and some of the world's most talented display companies, Sleep to Live introduced their newest display for the diagnostics system, which is scalable depending on retailers' needs. The new Sleep to Live display enhances the consumer experience and brings mattress shopping to a new level.

"At Sleep to Live, we are changing the way people sleep," said Eric Hinshaw, chairman and CEO of Kingsdown, Inc. "With our latest updates and technological advances, our products now offer the highest standards in the industry and give retailers and customers a more individualized, customizable approach to analyzing sleep choices and selecting the best mattress."

Sleep to Live was developed by industry leader and innovator, Kingsdown, Inc., a company founded in 1904 in Mebane, NC, that serves leading retailers across the United States, and in over 20 countries.  The Sleep to Live system is a new generation in sleep technology to determine the best sleep surface for your body. Products are made to order using handcrafted techniques combined with state-of-the-art materials and equipment. Research and development, training and distribution facilities, as well as two manufacturing facilities are also located at its Mebane headquarters. International offices are located in Bangkok, Thailand and Tokyo, Japan. Additional manufacturing and distribution centers are located in Winchester, VA; Muskogee, OK; Lakeland, FL; Knoxville, TN; Toronto and Calgary, Ontario; Derby, UK; and Melbourne, Australia. For more information, visit www.sleeptolive.com.

SOURCE Sleep to Live

Sereno™, The Center for Snoring Solutions, opened its doors to patients this month at its flagship practice in San Francisco.  Sereno is the first medical center of its kind dedicated solely to resolving snoring issues by providing patients with a comprehensive, solutions-based approach.

Snoring is serious and affects the lives of 90 million Americans, according to The National Sleep Foundation.  In addition, 24% of couples sleep apart because of snoring issues.  

Sereno was developed in response to this overwhelming need for a medical practice dedicated to alleviating snoring.  While other medical professionals administer various snoring procedures as part of their larger practices, Sereno offers a comprehensive, minimally invasive solution designed to treat each patient's particular causes of snoring. Sereno's holistic approach includes a customized lifestyle, diet and nutritional program.  

Said Sereno medical director Dr. Matthew Mingrone, "When patients learn there is an accessible and viable solution to their snoring problems, they are amazed that they have suffered for so long without getting medical treatment."  Mingrone adds, "Empowering patients to lead happier, healthier lives is our end goal."  

Staffed by highly trained medical professionals utilizing FDA-approved techniques that can usually be performed in less than an hour, Sereno offers patients the potential for a better life.  

Sereno™ is a revolutionary new practice dedicated to improving patient's lives through comprehensive treatment of snoring.  Sereno is headquartered in San Francisco and aims to expand nationally based on consumer demand.  Call 415-525-8400 or visit www.serenocenter.com to learn more.

Tempur-Pedic International Inc. (NYSE: TPX), the leading manufacturer, marketer and distributor of premium mattresses and pillows worldwide, today unveiled two new products in its TEMPUR-Cloud™ Collection, the TEMPUR-Cloud™ Luxe bed and TEMPUR-Cloud™ Pillow. The company also premiered new TV advertising, filmed on location in St. Cloud, MN, which showcases TEMPUR-Cloud Collection mattresses and invites consumers to ask TEMPUR-Cloud owners what makes their bed so special.

Like the TEMPUR-Cloud™ Supreme that launched last fall as part of the TEMPUR-Cloud Collection, the TEMPUR-Cloud Luxe and TEMPUR-Cloud Pillow feature the all-new, revolutionary TEMPUR-ES™ material. TEMPUR-ES is a breakthrough in sleep technology that creates a soft, pillowy sleep surface while still providing Tempur-Pedic's customary pressure-relieving comfort and therapeutic support. The core of the TEMPUR-Cloud Luxe will feature a thicker layer of TEMPUR-ES atop TEMPUR-HD® for a luxuriant and restful sleep experience. The TEMPUR-Cloud Pillow, filled with thousands of TEMPUR-ES micro-cushions, provides unparalleled neck support and soft-as-a-cloud comfort, ideal for all sleepers.

"The TEMPUR-Cloud Collection was developed through extensive research and a deep understanding of what many consumers want most in a mattress - softness and support without the problems they experience with traditional pillow-tops," said Rick Anderson, president of Tempur-Pedic North America. "We have already seen strong sales for the TEMPUR-Cloud Supreme, and are confident consumers will be just as excited about the newest additions to the TEMPUR-Cloud Collection."

The TEMPUR-Cloud Supreme is currently available at Tempur-Pedic retailers and through tempurpedic.com. The TEMPUR-Cloud™ will become available later this month and will retail for $1,999 (Queen Flat Set). The TEMPUR-Cloud Pillow will be in stores and online early this summer and will retail for $129 (Standard Size). Available this fall, the TEMPUR-Cloud Luxe, the most luxurious mattress in the collection, will retail for $3,999 (Queen Flat Set) and, like all Tempur-Pedic mattresses, will come with a 20-year limited warranty. For more information on the TEMPUR-Cloud, TEMPUR-Cloud Supreme and other Tempur-Pedic products, visit tempurpedic.com. Additional TEMPUR-Cloud Luxe and TEMPUR-Cloud Pillow information will become available later this year.

Sleep and health are closely connected and a new mattress can help with better sleep according to Oklahoma State University sleep experts. McRoskey owner Robin McRoskey Azevedo says that most people begin their search for a new mattress long after it's due. Azevedo adds, "More research is linking good health to getting good rest. We hear of this almost daily from our customers."

OSU research links greater sleep quality and reduced back pain, stiffness and shoulder pain to sleeping on a new mattress as compared to mattresses five years or older. According to OSU lead researcher Bert Jacobson, EdD, timely replacement and mattress quality can have a positive impact on sleep and overall quality of life. Jacobson's latest study appeared in the Journal of Ergonomics and offers fresh analysis of work published by the Journal of Chiropractic Medicine in 2006.

McRoskey Mattress Company has handcrafted mattresses in San Francisco since 1899, and offers these tips to determine if you need to replace your mattress.

TIPS ON EVALUATING YOUR MATTRESS: IS IT TIME FOR A NEW ONE?

• Do you wake up with stiffness or aches?
• Have you had a better night's sleep somewhere other than your own bed?
• Is your mattress overused?
• Does it sag, have an exposed interior or lumps?
• Are you no longer comfortable on your mattress and box spring?

If you answered yes to any of these, it's time to replace your mattress. Before you begin your search for a new mattress, do your homework to know what constitutes a quality mattress.

When testing the mattress, lie down on it for at least 15 minutes.

Comfort is personal. Softness or firmness isn't necessarily better. Choose a mattress that allows your body to relax naturally. Size relates to comfort. Choose a size that fits you and is large enough for movement.

SOURCE McRoskey Mattress Company

VIVUS, Inc. (Nasdaq: VVUS) plans to announce the results from a phase 2 study evaluating the safety and efficacy of Qnexa, for the treatment of obstructive sleep apnea (OSA), on January 7th prior to market open. The announcement will be followed by a webcast and conference call at 8:30 a.m. Eastern time.

Conference Call Information

Domestic callers: 1- 888-806-6202

International callers: 1- 913-312-6680

Webcast information: http://ir.vivus.com. A webcast replay will be available on the VIVUS web site for 30 days.

About the Sleep Apnea (OB-204) Study

The phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years of age with OSA (apnea/hypopnea index greater than or equal to 15) at baseline, who had not been treated with, or who were not compliant with continuous airway pressure (CPAP) devices within three months of screening. Patients were randomized to placebo or full-dose Qnexa. Patients underwent a four-week dose titration followed by 24 weeks of additional treatment. All patients were also provided with a lifestyle modification program focusing on diet and exercise. Overnight polysomnography was performed at baseline, Week 8 and Week 28. The primary endpoint was the change in Apnea/Hypopnea Index (AHI) between baseline and Week 28; secondary endpoints included weight loss, oxygen saturation and changes in blood pressure.

About Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. Approximately 18 million Americans are living with OSA, though an estimated 90 percent of patients remain undiagnosed or untreated. Studies have identified a relationship between OSA and a number of cardiovascular and metabolic diseases including hypertension, diabetes, stroke, congestive heart failure and sudden cardiac death. Currently, there are no pharmacotherapy agents approved to treat sleep apnea. More information on sleep apnea can be found on the American Academy of Sleep Medicine website at: http://www.aasmnet.org/Resources/FactSheets/SleepApnea.pdf

Source: VIVUS

 

Leader in Opiate and Ambien Detoxification Shares Insight into the Effects of Ambien Misuse and Withdrawal

The Waismann Method, a pioneering medical opiate detoxification procedure, offers one of the most advanced medical procedures worldwide with the medical expertise and advanced technology to treat dependencies to Zolpidem, a prescription medication widely used for the short-term treatment of insomnia and prescribed under trade names including Ambien and Edluar. The Waismann Method of Rapid Ambien Detox involves a safe, medically-assisted treatment to Ambien addiction in a hospital setting. This approach offers patients an alternative to traditional Ambien detoxification, which even when done gradually, can be extremely dangerous and even life threatening.

"Sleep problems are common in today's society. Ambien and other prescription sleep aids can help insomnia, but should only be taken as an interim resolution," said Dr. Michael Lowenstein, co-director for the Waismann Method. "When Ambien is taken for an extended period of time or in high doses, users can develop a tolerance to the drug, making it habit forming. Misuse of Ambien can potentially lead to short-term memory loss as well as bizarre side effects such as binge eating or sleepwalking."

Ambien, the brand name of Zolpidem, is a non-narcotic sleep aid meant for short-term treatment. It is considered a Schedule IV Controlled Substance in the U.S. and is a central nervous system depressant which slows normal brain activity. The sedative is also considered a hypnotic with effects similar to drugs in the benzodiazepine family such as Xanax, though they are molecularly different. Ambien can impair thinking and reaction time so users should avoid tasks that require alertness, such as driving or operating machinery.

According to Lowenstein, if a user develops a tolerance to Ambien and attempts to abruptly discontinue use, serious withdrawal symptoms can arise including insomnia, fatigue, panic attacks, stomach cramps, muscle cramps, sweating, shaking and seizures. Gradually decreasing daily intake is the best way to wean from Ambien, but many people need medically-supervised treatment. "Trying to detox on your own can be dangerous and should be supervised in a medical setting where withdrawal can be managed," Lowenstein adds.

Medically assisted withdrawal using Rapid Ambien Detox enables individuals to safely and comfortably reverse their dependence without difficult and prolonged withdrawal. The Waismann Method of Rapid Ambien Detox takes approximately seven to ten days, as opposed to traditional detoxification methods that require 30 to 90 days or more, and can be administered alone or concurrently with deep sedation detoxification from opiates.

Patients in the Waismann program are supervised closely in a hospital setting to maximize success and safety. All Waismann Method physicians are Board Certified in Anesthesiology, Pain Management, and Addiction Medicine. Treatment is tailored to the unique medical needs of each individual patient.

To learn more about Rapid Ambien Detox or the Waismann Method call 1-800-423-2482 or visit www.opiates.com.

About The Waismann Method:  Performed in a hospital, the Waismann Method involves the administration of medications to reverse the physiological dependence on opiates or Zolpidem while the symptoms of withdrawal are addressed. During the procedure, the patient experiences minimal withdrawal, and will be able to return home within days. Seventy-five percent of the prescription drug dependent patients who are treated with the Waismann Method remain drug free after one year.

SOURCE Waismann Method

Apnex Medical, Inc., a private medical device company, announced that it has completed a second round of private equity financing totaling $14 million. The funds will be used to complete a clinical study and develop a second generation of its proprietary implantable technology designed to treat obstructive sleep apnea (OSA).

Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman. The current board includes Robert Atkinson, CEO, and Michael Berman, Chairman, together with Brian Chee, John Nehra and Nimesh Shah representing Polaris, NEA and Domain, respectively. This financing brings the total investment in Apnex Medical to $30 million.

"We are very excited about the early results with the Apnex Hypoglossal Nerve Stimulation (HGNS(TM)) System in our clinical study. Our technology really has the potential to change the lives of people suffering from OSA. This round of financing will allow us to finish our initial clinical study and get us that much closer to market," said Robert Atkinson, CEO.

"From prior research published by Drs. Alan Schwartz and Philip Smith, we know that hypoglossal nerve stimulation has the potential to reduce OSA severity. The clinical study of the Apnex HGNS System should provide evidence of its safety and effectiveness over time," said Mr. Atkinson. Drs. Schwartz and Smith, both Professors of Medicine at Johns Hopkins University School of Medicine, are among the early pioneers in this field and serve as consultants to Apnex Medical.

About Obstructive Sleep Apnea (OSA):

"OSA is a very serious health condition, and if left untreated, it can lead to major health problems. Currently the majority of sleep apnea remains undiagnosed and among those who are diagnosed, many are either untreated or only partially treated. Thus, many of us are supportive of research into new forms of therapy," said Atul Malhotra, Medical Director of the Brigham and Women's Sleep Disorders Research Program and an Associate Professor at Harvard Medical School in Boston. Dr. Malhotra performs research into the mechanisms underlying sleep apnea and serves as a consultant to Apnex Medical. Malhotra further stated, "If you think you have a sleep problem, you should talk to your doctor or consider seeing a specialist."

According to the World Health Organization, approximately 100 million people worldwide are suspected to have OSA. In the United States, symptomatic OSA affects 1 in 4 men and 1 in 9 women. OSA causes fragmented sleep and excessive daytime sleepiness, resulting in an increased risk in accidents and lost productivity. Untreated OSA is also associated with an increased risk in stroke, high blood pressure, coronary artery disease, heart failure and type 2 diabetes. Recent studies have also confirmed that untreated OSA is associated with an increased risk of death. Current OSA treatments are not always successful or well tolerated. The Apnex HGNS System is designed to provide an alternative treatment for OSA that addresses these problems.

SOURCE Apnex Medical, Inc.

The American Trucking Associations (ATA) will co-sponsor the first-ever national conference on sleep apnea and commercial motor vehicle drivers on May 12, 2010.

Obstructed sleep apnea (OSA) is a condition in which an individual's airway is blocked while sleeping, typically resulting in frequent breathing interruptions lasting from 10 seconds to more than a minute at a time, loud snoring and non-restorative sleep. The illness afflicts at least 20 million Americans -- equal to or more than asthma or diabetes -- yet more than 85 percent remain undiagnosed. Individuals with OSA are more likely to have high blood pressure, heart problems, stroke and depression, contributing to annual health care costs that are twice that of people without sleep apnea.

"It is important that the trucking industry actively engages in improving the quality of life and the performance of our drivers," said ATA President and CEO Bill Graves. "Professional truck drivers play a vital role in delivering our nation's freight."

The conference, hosted by the American Sleep Apnea Association (ASAA), will feature presentations and panel discussions that focus on providing a common understanding of OSA diagnosis and treatment, clarifying current and proposed regulations, establishing an ongoing forum of experts to generate guidance for improvements, and providing trucking management with the resources to improve employee health and safety.

"The trucking industry continues to grapple with the tough questions and issues surrounding screening and treatment for sleep apnea," said Dave Osiecki, ATA Vice President of Safety, Security and Operations. "This event is a significant step forward and we encourage industry stakeholders to participate."

The one-day conference will be held at the Westin Baltimore Washington - BWI in Baltimore, Md. and is preceded by a reception and keynote address from National Transportation Safety Board Chairman Deborah Hersman on May 11, 2010.

For more information, visit the ASAA conference Web site at www.satc2010.org.

The American Trucking Associations is the largest national trade association for the trucking industry. Through a federation of other trucking groups, industry-related conferences, and its 50 affiliated state trucking associations, ATA represents more than 37,000 members covering every type of motor carrier in the United States.

SOURCE American Trucking Associations