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Proposed Sleep Aid Linked With Increased Drowsiness, Suicidal Thoughts

Filed May 22nd, 2013 Laurie

Federal health officials said this week that a new sleep-aid drug, suvorexant, being proposed for the open market is effective at helping people sleep but that it also increases the risk of daytime drowsiness, to the extent of it impacting a person’s safety.

According to an Associated Press (AP) report, the U.S. Food and Drug Administration (FDA) announced Monday (May 20) that suvorexant was effective at helping people sleep; however, people taking the drug during clinical trials suffered from an increased rate of daytime drowsiness. Sometimes, that drowsiness affected the person’s driving the next morning.

In the trial, conducted by Merck & Co., company researchers noted that people taking between 20 and 40 milligrams of suvorexant had difficulty remaining in the same driving lane during a test. Four women taking the test reportedly had to stop altogether because they were too tired.

In addition to the risks of excessive tiredness, the FDA’s review of suvorexant found that people taking the proposed new sleep aid also displayed an increased rate of suicidal thinking. In the one-year period in which the FDA reviewed Merck’s testing, eight people taking suvorexant experienced suicidal thoughts or acted with suicidal tendencies. No one taking a placebo during Merck’s testing displayed any of these behaviors, according to the AP report.

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