New Insomnia Drug, Belsomra, Approved in the United States

by Martin Reed Patient Advocate

A new first-in-class prescription drug for insomnia was approved for release in the United States in August 2014. The drug, Belsomra (suvorexant), is an orexin receptor antagonist. It works by altering the signaling of orexins - neurotransmitters which regulate the sleep-wake cycle. The drug has been classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA).

As it is a new drug, finding the best dosage for patients will take time. As such, the U.S. Food and Drug Administration (FDA) approved four different strengths of the medication. Dosages are available in 5, 10, 15 and 20 mgs. Physicians are advised to start patients out on a very low dosage and increase the dosage until an effective one is found. The FDA stated that total dosage should not exceed 20 mg daily. Belsomra should be taken within half an hour of bedtime when at least seven hours are available for sleep.

The drug was approved in the United States after three clinical trials found that participants who took the medication fell asleep faster and spent less time awake during the night when compared to those who took a placebo. The drug works differently on the brain than other sleeping pills on the market, such as Lunesta and Ambien, but it has not been compared against other prescription insomnia medications.

The most common adverse side effect reported by clinical trial participants was drowsiness. The FDA asked the drug manufacturer, Merck (known as MSD outside the United States and Canada) to perform next-day driving tests on both male and female participants who were given 20 mg dosages. The test found the drivers to be impaired. As such, the FDA advises physicians to alert and caution patients that dosages of Belsomra at this level can impede driving and other activities which require full attention and alertness. Patients who take lower dosages should also be advised of the risk of impeded daytime wakefulness, as well as impaired driving risks, and use caution as sensitivity to the drug will vary from person to person. Alcohol should be avoided while taking Belsomra.

Individuals who have a history of mental illness, depression, suicidal thoughts, a history of alcohol or drug abuse, a history of muscle weakness, narcolepsy, liver problems, lung or breathing problems, are pregnant or plan on becoming pregnant, are breastfeeding or planning to breastfeed should disclose this information to their physician prior to being prescribed Belsoma. Children under the age of 18 should not be given the drug as its safety for use in this age group has not been determined.

It should be noted that because Belsomra is a Schedule IV drug, there is a potential for abuse. This classification means that medication refills will be limited. The drug will also be subject to tighter packaging, registration, labeling and other requirements. The drug is expected to be avaiable in pharmacies in early 2015.

Martin Reed
Meet Our Writer
Martin Reed

Martin is the creator of Insomnia Coach, an eight-week course that combines online sleep education with individual sleep coaching. His course helps clients improve their sleep so they can enjoy a better life with more energy and start each day feeling happy, healthy, rested, and refreshed. Martin also runs a free sleep training course that has helped over 5,000 insomniacs. He holds a master’s degree in health and wellness education and studied clinical sleep health at the University of Delaware.