FDA Approves New Insomnia Drug Quviviq

The makers of Quviviq say their new insomnia drug will help people sleep better with less grogginess the next day.

The makers of the new drug Quviviq say it helps people sleep better with less grogginess. Beyhes Evren/Getty Images

Swiss drugmaker Idorsia believes it may have the answer for the third of the people in the United States who say they don’t get enough sleep..

Its new insomnia drug, Quviviq, has received approval from the Food and Drug Administration (FDA) to treat adults. It’s scheduled to hit the market in May.

Jean-Paul Clozel, the CEO of Idorsia, told Healthline that Quviviq is unique because the drug acts quickly and keeps working over an extended period.

More importantly, he said, after 7 to 8 hours, the person using the medication wakes up refreshed.

“There are hundreds of drugs that make you sleep,” Clozel said. “Not one is like this one.”

Clozel said his team of about 100 worked on developing the drug for more than 25 years.

He said they were motivated by the understanding that sleep disorders impact a wide swath of society and that drugs that exist now often leave users groggy the next morning.

“Everybody knows someone who (struggles with sleep disorders),” Clozel said. “We can change the lives of millions of people.”

Quviviq was approved in doses of 25 and 50 milligrams (mg) based on data from two late-stage trials that showed statistically significant and clinically meaningful improvements in sleep during the night and daytime functioning over a sustained period.

Not a ‘magic wand’

For those who treat sleep disorders, the approval of Quviviq isn’t groundbreaking, according to Dr. Harly E. Greenberg, the chief of the Division of Pulmonary, Critical Care and Sleep Medicine Medical and the director of the Northwell Health Sleep Disorders Center in New York.

However, Greenberg told Healthline, the medication is another option for providers to consider using with patients who need it.

Greenberg said Belsomora and Dayvigo, which are both already on the market, have similar mechanisms as Quviviq.

There are, Greenberg said, some benefits he can see with Quviviq.

Quviiviq seems to have no depression of breathing when a person uses it, Greenberg explained, and studies show less falls by users, meaning it could be a good choice for older adults who need sleep medication.

And with the medication’s duration, Greenberg said, “If someone (is using one of those other two similar medications) and does really well but feels groggy in the morning,” Quviviq could be an alternative.

For those who suffer acute sleeplessness, he said, the new drug could be a short term solution.

But for those with chronic sleep issues, no medication should ever been seen as a solution on its own.

Rather, Greenberg said, people should work with a medical team on behavior management.

Things such as cognitive therapy and strategies to reduce stress should always be part of a sleep treatment plan, he said.

Personal points of view

For years, Patty Goldberg has struggled to fall asleep and then fought daytime grogginess.

The 60-year-old Connecticut woman told Healthline her hope is simple.

“Someday I hope to be able to fall asleep at a normal hour and sleep through the night and not wake up exhausted,” she said.

For Goldberg, sleep began to elude her in her early 50s.

Since then, achieving a full night of sleep — and more importantly, a morning and day she feels fully rested — has been elusive.

She’s tried the tricks, Goldberg said, and still, “it’s a crapshoot if I can fall asleep or how long it will take.”

“I can lay in bed for 3 hours, just hoping,” she added.

Goldberg tried medications in the past but found they left her exhausted the next day.

Neal Patrick is in his late 20s and also struggles with sleep disorders.

“Fighting sleep feels like a game that you can’t win,” he told Healthline.

“You can have had a full day of being busy and when you get into bed at the end of the night, sleep just eludes you,” he added. “You can tell the nights when it’s going to be more severe because you never start to feel tired. I would say that it affects me to some degree 5 to 6 days of the week.”

Patrick has tried homeopathic solutions such as watching YouTube videos designed to calm, listening to rain and other soundtracks, using a blackout curtain, and even drinking a warm glass of milk.

Little help, he said.

Medications worry him since he has to be on his A-game for work each day.

This new medication, he said, sounds promising.

“Being able to get a solid 7 to 8 hours of sleep without feeling groggy the next day would allow me to be far more productive than I am on most days,” he said.

Clozel said that with the FDA approval behind them, the company now moves to the marketing phase.

“We want the problem of sleep in America to be hypervisible,” he said.

Helping cut down on sleeping problems, he said, will help other things as well, like depression and weight management.

The drug will be available to be prescribed to adults in May.

This story originally appeared on: Healthline.com - Author:Moira McCarthy