Post Reply 
[News] Investigational Insomnia Drug, Suvorexant
Author Message
ApneaNews Offline
Apnea News Correspondent
Advisory Members

Posts: 170
Joined: Feb 2012

Machine: IBM Selectric II
Mask Type: Full face mask
Mask Make & Model: 3M N95 (it gets dusty in the newsroom)
Humidifier: Sears Kenmore (circa 1979)
CPAP Pressure: 3200 psi
CPAP Software: Other Software

Other Comments: I report, therefore I am.

Sex: Undisclosed
Location: In the newsroom (where else?)

Post: #1
Investigational Insomnia Drug, Suvorexant
Merck Releases New Data for Investigational Insomnia Drug, Suvorexant

Merck has made public new data for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia. The new data are from one of the longest, continuously dosed, placebo-controlled trials of a sleep medication ever conducted. This 12-month study was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy. Merck presented new results from a 2-month discontinuation phase that followed the 12-month study at the 21st Congress of the European Sleep Research Society (ESRS).

“The methods used in this study allowed us to understand what happened when patients who had been taking suvorexant every night for a year were immediately switched to placebo, because what happens when patients stop taking a sleep medication is a key concern for both patients and healthcare professionals,” said James K. Walsh, PhD, executive director and senior scientist, Sleep Medicine and Research Center, St. Luke's Hospital, and visiting professor, Department of Psychiatry, Stanford University School of Medicine. "We found that the patients who had been taking suvorexant for 12 months and were switched to placebo saw their insomnia return, but clinically meaningful withdrawal symptoms and rebound insomnia did not emerge. We also obtained efficacy data from patients who continued to take suvorexant through 14 months."

Specifically, results from the 2-month discontinuation phase showed that, after daily use of a consistent dose of suvorexant for 1 year, patients who stopped taking the medicine experienced a return of their sleeping difficulties to levels similar to those reported by patients who received placebo over the course of the trial. Patients who continued to receive suvorexant for the additional 2 months experienced mean improvements in their ability to fall asleep and stay asleep that were consistent with those seen over the first 12 months compared to placebo. Adverse experiences reported in the 2-month discontinuation phase were generally consistent with those reported during the 12-month study.

Merck plans to submit a New Drug Application (NDA) for suvorexant to the US Food and Drug Administration (FDA) in 2012. If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

“Suvorexant represents a new and different approach to treating insomnia, an area of significant unmet need,” said Darryle D. Schoepp, PhD, senior vice president and head of Neuroscience and Ophthalmology franchise, Merck Research Laboratories. “We are enthusiastic about the results of this long-term study, which provide important insights into suvorexant and the chronic nature of insomnia. Merck is continuing with plans to seek approval for suvorexant in the United States and in other countries around the world.”

fair use from:

The above post may contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. The material available is intended to advance the understanding of Sleep Apnea treatment and to advance the educational level of Sleep Apnea patients with regard to their health. Sometimes included is the full text of articles and documents rather than a simple link because outside links frequently "go bad" or change over time. This constitutes a "fair use" of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material in this post is distributed without fee or payment of any kind for research and educational purposes. If you wish to use copyrighted material from this post for purposes of your own that go beyond "fair use", you must obtain permission from the copyright owner.
09-25-2012 09:13 AM
Find all posts by this user Post Reply Quote this message in a reply

Donate to Apnea Board
Post Reply 

Possibly Related Threads...
Thread: Author Replies: Views: Last Post
  Bernerbits' ongoing CPAP/meds/insomnia saga bernerbits 58 1,751 10-18-2016 09:32 AM
Last Post: bernerbits
  Insomnia getting worse 3 months into therapy baconjurer 3 355 10-05-2016 11:50 PM
Last Post: PoolQ
  Sleep Wake Junk and insomnia 0rangebear 5 367 07-09-2016 02:49 PM
Last Post: Crimson Nape
  insomnia & cpap not giving restful sleep doowop44 8 774 02-25-2016 04:21 PM
Last Post: doowop44
  CPAP Insomnia julrez9 11 1,478 11-28-2015 07:40 PM
Last Post: OpalRose
  Please Help with AHIs Too High/Bad Insomnia bluemom51 16 1,360 10-31-2015 03:06 PM
Last Post: trish6hundred
  Trazodone for insomnia Dolla Bill 18 2,493 10-10-2015 04:57 AM
Last Post: 49er

Forum Jump:

Who's Online (Complete List)