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The Sleep Wellness Institute today opens its second sleep center location … in Mequon, WI.  With the addition of the second location, Sleep Wellness now offers 14 sleep study rooms and physician directed care that is provided by six highly regarded sleep medicine physicians.

The physicians are:  Don Harden, MD, Medical Director; JoAnna Galezowska, MD; Marc Rasansky, MD; Gary Leo, DO; Michael Connor, DO; and Dima Adl, MD.

One convenient telephone number may be used to access services at both the Mequon and West Allis locations?:  414-336-3000. And information on The Sleep Wellness Institute is available online at www.sleepwellandlive.com.

The Mequon sleep lab is the former Columbia St. Mary’s sleep disorders center located at 11725 N. Port Washington Road.  We and Columbia St. Mary’s have formed a partnership to provide convenient, high quality sleep disorders services to patients throughout southeastern Wisconsin, as well as clear, concise, and prompt reports to referring physicians.

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People often ask us what we  recommend to help them fall asleep.  Here are some tips that will help you develop habits that can help you to fall asleep and stay asleep.

  • Ensure adequate exposure to natural light during the day.
  • Exercise in the morning or late afternoon can promote good sleep.
  • Stay away from large meals close to bedtime.
  • Avoid stimulants such as caffeine, nicotine, and alcohol 4 hours before bedtime.
  • Avoid using electronic devices (computers, cell phone texting, video games) 1 hour before bed.
  • Keep a notepad and pencil by your bed to write down any thoughts that may wake you up at night.
  • Turn your alarm clock around so it’s not facing you; do not look at the clock during the night as this can cause more stress and anxiety about your sleep.
  • If you wake up during the night and can’t fall back asleep, get out of bed (do NOT use the computer).  Go back to bed only when you feel sleepy again.
  • Associate your bed with sleep.  It’s not a good idea to use your bed to watch TV, listen to the radio or read.
  • Make sure your sleep environment is pleasant and relaxing.  The bed should be comfortable and the room should not be too hot or cold, or too bright.
  • Establish set times for waking and sleeping.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Somaxon Pharmaceuticals, San Diego, for the company’s New Drug Application (NDA) for its insomnia drug Silenor (doxepin).  After review, the FDA determined that the NDA “cannot be approved in its present form.”   The FDA raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor NDA.

Although the FDA noted that there were no adverse events observed in the clinical studies included in the NDA that would preclude approval, the FDA asked Somaxon to address the possibility that doxepin may prolong the cardiac QT interval.

The company intends to respond by submitting the results of its completed clinical trial of doxepin that evaluated the potential for electrocardiographic effects to the FDA.  The results of this clinical trial demonstrated that doxepin had no effect on QT interval prolongation when administered at 6 mg or 50 mg.

“We continue to believe that the data in the NDA we have submitted, together with the QT data we will submit is sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia,” said Richard W. Pascoe, president and chief executive officer of Somaxon.

The FDA indicated that it was open to a discussion of the concerns and did not specifically request the company to conduct additional clinical trials of Silenor.  Somaxon plans to schedule a discussion with the FDA to gain a complete understanding of the implications of the issues raised in the Complete Response Letter.

~ From Sleep Review