Magazine article Clinical Psychiatry News

Suvorexant Helps Patients Fall Asleep Sooner and for Longer

Magazine article Clinical Psychiatry News

Suvorexant Helps Patients Fall Asleep Sooner and for Longer

Article excerpt

AT THE ANNUAL MEETING OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES

BOSTON--The promise of shorter time to sleep, longer sleep duration, and fewer side effects associated with the experimental sleep drug suvorexant has sleep medicine clinicians and their patients eagerly anticipating the approval of the first-in-class agent.

Suvorexant's mechanism of action in targeting the orexin system, which promotes wakefulness, sets it apart from some of the available sleep medications, said Dr. Michael Thorpy, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center in New York. "The effects of the new drug are fairly localized because it targets a more specific receptor than do the GABA agonists, which have a more generalized effect and thus more side effects." Suvorexant does not depress the CNS or respiratory function and thus may be a good option for patients with suspected sleep apnea.

Two pivotal phase III studies of the drug were presented at the meeting. Both randomized, double-blind, placebo-controlled trials were 3-month studies designed to confirm the safety and efficacy outcomes of an initial 4-week proof-of-concept study in patients with primary insomnia. Each trial evaluated two dose regimens: 40 mg for patients 18-64 years and 30 mg for those older than 65 years in the first trial; and 20 mg and 15 mg, respectively, in the second trial, said Dr. An-drew D. Krystal, professor of psychiatry and behavioral sciences at Duke University Medical Center, Durham, N.C., and an investigator for both trials.

Efficacy measures were patient self-reported time to sleep onset (sTSO), self-reported total sleep time (sTST), and self-reported wake after sleep onset (sWA-SO), as well as the polysomnographic end points of latency to onset of persistent sleep (LPS) and wake after persistent sleep onset (WASO), he said.

In the first trial, which randomized 1,021 patients, suyorexant at 40 mg and 30 mg was significantly better than placebo in all end points at 1 and 3 months. At 3 months, the mean differences from placebo in change from baseline were an increase of 19.7 minutes for sTST, and decreases of 8.4 minutes for sTSO, 6.9 minutes for sWASO, 9.4 minutes for LPS, and 22.9 minutes for WASO.

Similarly, significant changes were seen in the second trial, with the exception of the drug's effect on LPS at 3 months, which was not significant--a finding the researchers attributed to high placebo response. …

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