FDA Approves New Insomnia Treatment
There will be another prescription treatment available for people suffering from insomnia, which is a disorder characterized by having difficulty sleeping or staying asleep. The U.S. Food and Drug Administration (FDA) has approved Merck, Sharpe & Dohme Corporation's Belsomra (suvorexant) tablets.
"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 [mg]," Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in an agency news release reported by Philly. "Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness."
"Today's approval of Belsomra allows for the introduction of a new treatment option for patients suffering from insomnia," added Dr. David Michelson, vice president, Neurosciences, Merck Research Laboratories, according to the Wall Street Journal. "Belsomra is the result of more than a decade of Merck research in neuroscience and provides tangible evidence of our long-standing commitment to innovation."
The drug was tested in three clinical trials that involved a total of more than 500 people. The researchers reported that Belsomra helped people fall asleep faster in comparison to people who took a placebo pill. Belsomra also decreased the amount of time people stayed awake throughout the night. Currently, the FDA does not know if Belsomra is safer or more effectiveness than other insomnia treatments on market because comparative studies have not been conducted.
According to the FDA, the drug should only be taken once a night, roughly half an hour prior to people's bed times. People taking the drug should dedicate at least seven hours of sleep before waking up. The daily dosage amount should not surpass 20mg.
One side effect of the drug is drowsiness the morning after. The drug manufacturer discovered that men and women who took the highest dose of Belsomra had impaired driving skills. People who are prescribed the drug, regardless of the dose, should be extra cautious when driving the morning after or performing other tasks that require full mental alertness.