JAN 11, 2022 2:00 PM PST

The FDA grants approval for a new insomnia drug to improve sleep in adults

WRITTEN BY: J. Bryce Ortiz

The Swiss biotech company Idorsia announced this week that it has received approval from the United States Food and Drug Administration (FDA) for its new drug that can help adult patients treat their insomnia. The sleeping pill, called Quviviq (daridorexant) is the first drug created by Idorsia that has received approval from the FDA, and, pending scheduling by the United States Drug Enforcement Administration (DEA), should be available to insomnia patients in May 2022. 

Insomnia is the most common sleep-related disorder in the United States. The American Academy of Sleep Medicine has stated that 30 to 35 of adults have brief insomnia, 15 to 20 percent have short-term insomnia (lasting less than 3 months), and at least 10 percent of adults have chronic insomnia (insomnia that occurs more than 3 times per week for longer than 3 months). Insomnia is characterized by poor sleep quality or duration and difficulty falling asleep and/or staying sleep.

Sleep is thought to be controlled by a variety of factors in the brain, including the hormone melatonin, the inhibitory neurotransmitter GABA, and a peptide hormone called Orexin. Past studies have shown that orexin neurons are active during wakefulness and inactive when we sleep. Furthermore, it has been shown that in humans and animals with narcolepsy – a condition characterized by excessive daytime sleepiness and uncontrollable sleep attacks – the condition is, in part, caused by a deficiency of the orexin peptide. As such, the drug Quviviq is a dual orexin receptor antagonist, which acts on the orexin system by blocking the effects of orexin from promoting wakefulness. Dr. Martine Clozel, Chief Scientific Officer at Idorsia, said, “After more than 20 years of research and a progressive understanding of orexin in sleep-wake balance, we designed [Quviviq] to help address several issues people with insomnia face. [Quviviq] properties include a potent inhibition of both orexin receptors, [and] a rapid absorption for sleep onset.”

The FDA granted approval for the drug based on data from a recent phase 3 clinical trial that showed that individuals who suffer from insomnia showed a statistically significant improvement in two measures of quality sleep after taking the drug. There were also few adverse side effects in the patients studied, which included headache and daytime fatigue. However, because of the potential for drug abuse and dependence, the drug has been listed as a federally controlled substance and the company is waiting to hear results from the DEA to begin marketing. However, the drug provides a new treatment option for adults with insomnia that can help improve their sleep and quality of life. 

 

Sources: IdorsiaAmerican Academy of Sleep MedicineThe LancetNational Institute of Neurological Diseases and Strokenature reviews neuroscienceVCA HospitalsNeurology;

About the Author
Doctorate (PhD)
Science and medical writer | Researcher | Interested in the intersection between translational science, drug development, and policy
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