The FDA has approved the , for the treatment of insomnia.
The drug, to be taken 30 minutes before bedtime, will come in four strengths -- 5, 10, 15, and 20 mg -- and will be classified as a schedule IV controlled substance, as it can lead to dependence, the agency said.
FDA also cautioned that the drug shouldn't be taken more than once per night, at a max dose of 20 mg, and that patients should be able to get at least 7 hours of sleep.
Studies also found patients' driving performance to be impaired the following day if they took a dose of 20 mg, so clinicians should advise their patients against driving and other activities that require "full mental alertness" the day after taking such a dose, the agency said.
"Like other sleep medications, there is a risk from Belsomra of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex," the agency said in a statement. "Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy."
The drug was approved following three clinical trials, involving more than 500 patients, which found those who took the drug fell asleep faster and stayed asleep longer than those on placebo. FDA noted that the drug wasn't compared to other insomnia medications.
An FDA advisory committee had recommended approval for suvorexant back in May 2013, but the FDA decided that safety and manufacturing problems had to be resolved before it would greenlight the drug.
The drug is made by Merck, Sharpe & Dohme of Whitehouse Station, N.J.