ClickCease New Medication for Insomnia Approved by the FDA | Easy Drug Card

New Medication for Insomnia Approved by the FDA

On January 10th, 2022, it was announced that a new drug called QUVIVIQTM (daridorexant) was approved by the FDA (US Food and Drug Administration) for insomnia with difficulty falling asleep or staying asleep. Insomnia is a disorder making it hard to fall asleep, stay asleep, or fall back asleep after prematurely waking. It is the most common sleep disorder in the United States. Those who suffer from insomnia know it not only affects your ability to sleep, but may affect your energy level, mood, performance, overall health, and quality of life during the day too.

Read our blog about Other Insomnia Treatments

QUVIVIQTM (daridorexant) is a new medication for insomnia that was shown to be effective based on two studies including a total of 1854 patients. The studies compared various doses of QUVIVIQTM to placebo and showed a significant improvement in sleep onset, sleep maintenance, and total sleep time as reported by patients taking the study medication. It was also found to be associated with significant improvements in daytime function for those taking the study medication. The most common side effects of QUVIVIQTM based on the studies were headache and somnolence or fatigue, but there was no evidence to suggest rebound insomnia or withdrawal occurred while taking the new medication. The medication was studied at 10mg, 25mg, and 50mg doses, but only the 25mg and 50mg doses will come to market, as the 10mg dose was not shown to be effective.

While this is a new medication, it belongs to a class of medications already available on the market. QUVIVIQTM is classified as a dual orexin receptor antagonist, the same medication class as Belsomra® (suvorexant) and Dayvigo® (lemborexant). Orexins are a type of communication signal in the brain (also called neuropeptides) that bind to our nerve cells and promote wakefulness. While we are still learning about orexins, it is thought that they are overactive in patients with insomnia. Dual orexin receptor antagonists work by blocking orexins from binding to nerve cells in a reversible way, which consequently turns down the overactive wakefulness that insomniacs suffer from.

Belsomra® and Dayvigo® are controlled substances, and the new medication QUVIVIQTM will be classified as a controlled substance as well. QUVIVIQTM is expected to be available in two different strengths, 25mg and 50mg, in May 2022 after it is scheduled by the US Drug Enforcement Administration (DEA) to the appropriate controlled schedule category. The manufacturer of QUVIVIQTM is a biopharmaceutical company headquartered in Switzerland called Idorsia.





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Dr. Andrea M. Jones

Dr. Andrea M. Jones is a clinical pharmacist specializing in transitions of care to facilitate a smooth transition for patients between the hospital and outpatient settings. Dr. Jones graduated from the University of Colorado School of Pharmacy and completed post-graduate year 1 residency at the Southern Arizona VA Healthcare System in Tucson, Arizona. Dr. Jones also worked in retail/community pharmacies for over 5 years during undergraduate studies at the University of Kentucky and pharmacy school at the University of Colorado.




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