In August 2014, the Food and Drug Administration (FDA) announced the approval of a novel new sleeping pill, Belsomra. The drug was the first in a class known as an orexin receptor antagonist designed to regulate the sleep-wake cycle in people who suffer from insomnia. But new reports suggest the drug may have “paradoxical reactions,” and cause a worsening of insomnia in some patients.
Insomnia is characterized by difficulty falling asleep or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause daytime sleepiness and lack of energy, and can make people feel anxious, depressed, or irritable. They may also have trouble staying alert, learning or remembering things.
The insomnia issue with Belsomra was identified during postmarket reviews by researchers with the FDA’s Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research (CDER). Every 18 months, or after a drug has been used by at least 10,000 people, postmarketing reviews are conducted to identify any new serious adverse events not previously identified during product development. The reviews also seek to determine if known side effects are occurring at a higher than expected number, or if there are any potential new safety concerns now that the drug is being used in the general population.
Now that the worsening insomnia issue with Belsomra has been identified as a possible risk, the FDA will continue to evaluate cases to determine whether further regulator action is required.
Anyone who has taken Belsomra and experienced side effects should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.