May 22, 2013         

FDA Should Reject Dangerous Sleep Medicine, Public Citizen Tells Advisory Committee

Like other sleep medicines, suvorexant is potentially habit-forming and impairs driving, posing grave risks to patients and public health

WASHINGTON, D.C. –The U.S. Food and Drug Administration (FDA) should not approve the new sleep medicine suvorexant because the drug’s long-lasting risks – both to patients and the general public – outweigh any short-term benefits to sleep, Public Citizen said today in testimony to the FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee.

Millions of Americans live with some form of sleep disorder. Suvorexant was developed to help some of these people get to sleep a bit more quickly and stay asleep for a few minutes longer.

However, suvorexant continues to exert its sleep-inducing effects long after a person wakes up in the morning because it stays in the body longer (for up to 3 days) than all but one of the currently available sleep medicines. Consequently, in the pre-approval studies, subjects given suvorexant at night experienced next-day drowsiness that was shown to impair their alertness and ability to drive. Five subjects (almost 5%) on suvorexant even had to stop the supervised driving tests for fear of falling asleep at the wheel.

Zolpidem (Ambien), another widely-used sleeping aid, has been associated with an increased risk of car accidents in at least two large studies to date, prompting a recent FDA alert warning patients not to drive the day after taking the drug. Suvorexant stays in the body six times longer than zolpidem, with patients more often than not unaware of their diminished ability to drive and perform other mental tasks.

Studies have found that suvorexant can cause suicidal thoughts, elevated cholesterol, and hallucinations. Public Citizen also testified that subjects who stopped using the drug experienced even worse sleep disturbances than they did before being placed on the drug. Patients on suvorexant could therefore likely become dependent on the drug over time, making it difficult to discontinue therapy even if side effects became severe.

“Like its predecessors, suvorexant’s marginal benefit in extending overnight sleep time by a few minutes is achieved at the expense of prolonged, next-day drowsiness, with potentially fatal consequences, in addition to a litany of other serious side effects” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “This drug poses far too great a risk to both patients and the general public to be on the market.”

To read today’s testimony, visit https://www.citizen.org/our-work/health-and-safety/articles/testimony-fda-peripheral-and-central-nervous-systems-drugs