A new drug to treat insomnia has been approved by the US Food and Drug Administration (FDA). Belsomra tablets are for use as required to alleviate difficulty falling and staying asleep.

Insomnia is a relatively common sleep disorder that causes people to have trouble falling and/or staying asleep. It can be acute or chronic, and can be triggered by life situations such as family pressures, work-related stresses, or a traumatic event.

Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, says that Belsomra should be taken no more than once per evening. It should be taken within 30 minutes of going to sleep, provided that at least seven hours is allotted to remain asleep before having to wake in the morning. No more than 20 mg should be taken on a daily basis.

“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. Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness,” said Unger in a statement.

Belsomra comes with its own set of potential risks, much like any other types of sleep medications. People taking the drug may engage in complex behaviors while not fully awake, including driving, preparing food, or making phone calls. These activities performed while a person is not fully awake can be exacerbated by the consumption of alcohol or other medications.

Belsomra is a controlled substance, as it can become addictive and lead to dependence.