FDA approves new insomnia drug
August 14, 2014
The U.S. Food and Drug Administration said on Wednesday it has approved a new insomnia drug made by Merck & Co.
The drug, to be called Belsomra, is the first in a new class of sedatives that block chemicals in the brain called orexins that help keep people awake.
Belsomra, known generically as suvorexant, has the potential to cause next-day sleepiness and impaired driving. As a result, the FDA said, no more than one pill should be taken per night and the dose should not exceed 20 milligrams.
The FDA had asked Merck to study the next-day driving performance of people who took the drug amid concerns the sedative could lead to next-day drowsiness.
The test showed impaired driving in patients who took 20 milligrams of the drug. Patients therefore "should be cautioned against next-day driving or activities requiring full mental alertness," the FDA said in a statement.
Even those who take a lower dose should be made aware of the potential for next-day driving impairment because individuals may respond differently to any given drug, the agency said.
The FDA approved the drug in 5, 10, 15 and 20 milligram doses.
continued here http://www.foxnews.com/health/2014/08/14/fda-approves-new-insomnia-drug/
August 14, 2014
The U.S. Food and Drug Administration said on Wednesday it has approved a new insomnia drug made by Merck & Co.
The drug, to be called Belsomra, is the first in a new class of sedatives that block chemicals in the brain called orexins that help keep people awake.
Belsomra, known generically as suvorexant, has the potential to cause next-day sleepiness and impaired driving. As a result, the FDA said, no more than one pill should be taken per night and the dose should not exceed 20 milligrams.
The FDA had asked Merck to study the next-day driving performance of people who took the drug amid concerns the sedative could lead to next-day drowsiness.
The test showed impaired driving in patients who took 20 milligrams of the drug. Patients therefore "should be cautioned against next-day driving or activities requiring full mental alertness," the FDA said in a statement.
Even those who take a lower dose should be made aware of the potential for next-day driving impairment because individuals may respond differently to any given drug, the agency said.
The FDA approved the drug in 5, 10, 15 and 20 milligram doses.
continued here http://www.foxnews.com/health/2014/08/14/fda-approves-new-insomnia-drug/