Orexin receptor antagonism for treatment of insomnia
A randomized clinical trial of suvorexant
Citation Manager Formats
Make Comment
See Comments

This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
ABSTRACT
Objective: To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia.
Methods: We evaluated suvorexant, an orexin receptor antagonist, for treating patients with primary insomnia in a randomized, double-blind, placebo-controlled, 2-period (4 weeks per period) crossover polysomnography study. Patients received suvorexant (10 mg [n = 62], 20 mg [n = 61], 40 mg [n = 59], or 80 mg [n = 61]) in one period and placebo (n = 249) in the other. Polysomnography was performed on night 1 and at the end of week 4 of each period. The coprimary efficacy end points were sleep efficiency on night 1 and end of week 4. Secondary end points were wake after sleep onset and latency to persistent sleep.
Results: Suvorexant showed significant (p values <0.01) dose-related improvements vs placebo on the coprimary end points of sleep efficiency at night 1 and end of week 4. Dose-related effects were also observed for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). Suvorexant was generally well tolerated.
Conclusions: The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia.
Classification of evidence: This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.
Glossary
- DSM-IV-TR=
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision;
- DSCT=
- Digit Symbol Copying Test;
- DSST=
- Digit Symbol Substitution Test;
- LPS=
- latency to persistent sleep;
- PSG=
- polysomnography;
- SE=
- sleep efficiency;
- sTSO=
- subjective time to sleep onset;
- sTST=
- subjective total sleep time;
- TST=
- total sleep time;
- WASO=
- wake after sleep onset
Footnotes
Coinvestigators are listed on the Neurology® Web site at www.neurology.org.
Study funding: Supported by Merck Research Laboratories. The funding organization was involved in the following: design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Go to Neurology.org for full disclosures. Disclosures deemed relevant by the authors, if any, are provided at the end of this article.
Supplemental data at www.neurology.org
- Received January 5, 2012.
- Accepted July 30, 2012.
- © 2012 American Academy of Neurology
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
For assistance, please contact:
AAN Members (800) 879-1960 or (612) 928-6000 (International)
Non-AAN Member subscribers (800) 638-3030 or (301) 223-2300 option 3, select 1 (international)
Sign Up
Information on how to subscribe to Neurology and Neurology: Clinical Practice can be found here
Purchase
Individual access to articles is available through the Add to Cart option on the article page. Access for 1 day (from the computer you are currently using) is US$ 39.00. Pay-per-view content is for the use of the payee only, and content may not be further distributed by print or electronic means. The payee may view, download, and/or print the article for his/her personal, scholarly, research, and educational use. Distributing copies (electronic or otherwise) of the article is not allowed.
Letters: Rapid online correspondence
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
You May Also be Interested in
Dr. Nicole Sur and Dr. Mausaminben Hathidara
► Watch
Topics Discussed
Alert Me
Recommended articles
-
Article
Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorderGary Zammit, Yves Dauvilliers, Scott Pain et al.Neurology, April 27, 2020 -
Article
Association of CSF orexin-A levels and nocturnal sleep stability in patients with hypersomnolenceLucie Barateau, Régis Lopez, Sofiene Chenini et al.Neurology, September 01, 2020 -
Articles
Sleep disturbance and melatonin levels following traumatic brain injuryJ.A. Shekleton, D.L. Parcell, J.R. Redman et al.Neurology, May 24, 2010 -
Articles
Restless legs syndrome improved by pramipexoleA double-blind randomized trialJacques Montplaisir, Alain Nicolas, Régine Denesle et al.Neurology, March 01, 1999