Efficacy and safety of suvorexant for the treatment of primary insomnia among Chinese: A 6-month randomized double-blind controlled study
- Author:
Baiya Fan
;
Jing Kang
;
Yalong He
;
Meimei Hao
;
Wei Du
;
Shihong Ma
- Publication Type:Journal Article
- Keywords:
Suvorexant;
insomnia;
randomized controlled trial;
clinical trial
- MeSH:
Sleep Initiation and Maintenance Disorders
- From:Neurology Asia
2017;22(1):41-47
- CountryMalaysia
- Language:English
-
Abstract:
Background: Insomnia often responds to the orexin receptor antagonist suvorexant. This study aimed to
evaluate the efficacy and adverse events of suvorexant for Chinese patients with primary insomnia over 6
months. Methods: A total of 120 patients with primary insomnia were assigned randomly to two groups
that received placebo or suvorexant (40 mg) for 6 months. The primary outcomes were the total sleep time
(sTST), time to sleep onset (sTSO), and sleep quality (sQUAL). The secondary outcomes were the Insomnia
Severity Index (ISI) score and adverse events. Results: A total of 111 patients completed the study and
all of them were included in the final analysis. Suvorexant showed greater efficacy than the placebo in
enhancing sTST, sTSO, sQUAL and ISI score at months 1 and 6. Serious adverse events were documented
in 2 patients (3.3%) in the suvorexant group and 1 patients (1.7%) in the placebo group. The most common
adverse event was somnolence, which occurred in 7 patients (11.7%) in the suvorexant group and 2 patients
(3.3%) in the placebo group. No death related to suvorexant treatment was recorded.
Conclusions: Suvorexant was efficacious and well-tolerated in a group of Chinese patients with primary
insomnia over 6 months.
- Full text:P020170413323978845519.pdf
