Aug. 14, 2014
CBS News - Approximately 60 million Americans have some form of insomnia, a condition that affects 40 percent of women and 30 percent of adult men. But a new type of sleeping pill may offer some hope.
On Wednesday the FDA approved "Belsorma," a new drug from Merck & Co., which will be available late 2014 or early 2015. It specifically targets brain chemicals that keep you awake, and speeds the onset of sleep.
Carol Ash, director of sleep medicine at Meridian Health, says the drug is a breakthrough for insomnia researchers.
"This is an exciting new drug," Ash said. "It really is a new tool and toolkit for the treatment of insomnia."
Ash says Belsorma is groundbreaking because the drug targets specific receptors in the brain.
"Usually sleeping drugs are a knockout punch to the brain; they knock out circuits throughout the brain," Ash said. "Think of a house where you get a surge and the electricity goes off for the refrigerator, the TV, not just the lights. This drug is like a switch that actually turns off the lights."
The drug works by inhibiting orexin, a neuro-chemical that keeps the brain awake.
Ash says that while the drug is more focused than existing insomnia medications, it still has similar side effects like daytime drowsiness and headaches.
"That's why the FDA actually delayed the approval of this drug," Ash said. "Because when they initially tried to launch it, they used higher doses that actually caused things like drowsy driving and thoughts of suicide, so it was actually a concern."
Patients who are prescribed the drug will receive information on potential safety issues, including sleep-walking, sleep-driving and other semi-awake activities.
Ash says the drug showed no signs of dependency in test phases.
"The statement from Merck is that when they did the study they didn't actually see any dependencies or any symptoms of withdrawal," Ash said. "But when they do these studies it's always a small number of patients. We have yet to see what will happen when they expand it to larger populations."
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