Quantcast
Get breaking news alerts via email

Click here to manage your alerts
FDA approves new sleeping drug from Merck
Pharmaceuticals » Belsomra is designed to help people with insomnia to stay asleep.
First Published Aug 13 2014 03:58 pm • Last Updated Aug 13 2014 03:58 pm

Washington • Merck & Co. Inc. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep.

The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night. It’s unclear whether the new drug is safer or more effective than older drugs because it was tested against a dummy pill, rather than other sleeping medications.

Join the Discussion
Post a Comment

The Food and Drug Administration approved the drug Wednesday in four different doses for various degrees of insomnia. The agency noted that patients who took the highest dose, 20 milligrams, experienced drowsiness and difficulty driving the next morning.

Doctors should warn patients taking the highest dose against next-day driving or activities that require full concentration, the FDA said. It added that side effects such as next-day drowsiness can be reduced by using the lowest effective dose. Drowsiness is a side effect listed on the labels of all anti-insomnia drugs.

In the last year, the FDA lowered the recommended dosage on Ambien, Lunesta and related drugs based on studies showing a link to driving problems and impaired memory and coordination. The agency cited research showing that the drugs remain in the bloodstream at levels high enough to interfere with activities that require focus and attention.

The FDA is requiring that patients who get the new drug receive a medication guide detailing the drug’s potential safety issues, including sleep-walking, sleep-driving and other semi-awake activities.

The agency said it approved Belsomra based on three company studies involving 500 patients that showed people taking it fell asleep faster and spent less time awake compared with people taking a dummy pill.

Like other prescription sleeping drugs, Belsomra is designed to be taken only once per night and only when patients have at least seven hours before they need to wake up.

Shares of Merck & Co. Inc., which is based in Whitehouse Station, New Jersey, rose 82 cents, or 1.4 percent, to close at $57.85.




Copyright 2014 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Top Reader Comments Read All Comments Post a Comment
Click here to read all comments   Click here to post a comment


About Reader Comments


Reader comments on sltrib.com are the opinions of the writer, not The Salt Lake Tribune. We will delete comments containing obscenities, personal attacks and inappropriate or offensive remarks. Flagrant or repeat violators will be banned. If you see an objectionable comment, please alert us by clicking the arrow on the upper right side of the comment and selecting "Flag comment as inappropriate". If you've recently registered with Disqus or aren't seeing your comments immediately, you may need to verify your email address. To do so, visit disqus.com/account.
See more about comments here.
Staying Connected
Videos
Jobs
Contests and Promotions
  • Search Obituaries
  • Place an Obituary

  • Search Cars
  • Search Homes
  • Search Jobs
  • Search Marketplace
  • Search Legal Notices

  • Other Services
  • Advertise With Us
  • Subscribe to the Newspaper
  • Access your e-Edition
  • Frequently Asked Questions
  • Contact a newsroom staff member
  • Access the Trib Archives
  • Privacy Policy
  • Missing your paper? Need to place your paper on vacation hold? For this and any other subscription related needs, click here or call 801.204.6100.