WHITEHOUSE STATION (dpa-AFX) - Merck & Co. Inc. (MRK), Wednesday said the US Food and Drug Administration has approved its new insomnia drug Belsomra for adults who have difficulty in falling and staying asleep.
Belsomra is a highly selective antagonist for orexin receptors, a chemical in brain which keeps a person awake. Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long.
'Today's approval of BELSOMRA allows for the introduction of a new treatment option for patients suffering from insomnia,' said Dr. David Michelson, vice president, Neurosciences, Merck Research Laboratories.
The FDA's recommended dose of Belsomra is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily.
'To assist health care professionals and patients in finding the best dose to treat each individual patient's sleeplessness, the FDA has approved Belsomra in four different strengths - 5, 10, 15, and 20 milligrams,' said Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. 'Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.'
The company has warned patients taking 20 mg against next day driving and other activities requiring full mental alertness.
MRK closed Wednesday's trading at $57.85, up $0.82 or 1.44%, on the NYSE.
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