Drugs You Don't Need for Disorders You Don't Have

One evening in the late summer of 2015, Lisa Schwartz was watching television at her Vermont home when an ad for a sleeping pill called Belsomra appeared on the screen. Schwartz, a longtime professor at Dartmouth Medical College, usually muted commercials, but she watched this one closely: a 90-second spot featuring a young woman and two slightly cute, slightly creepy fuzzy animals in the shape of the words "sleep" and "wake."

Schwartz had a reason to be curious about this particular ad. Two years earlier, she had been a member of the advisory panel that reviewed Belsomra for the U.S. Food and Drug Administration--and the process had not gone well for the manufacturer, Merck. The company saw its new drug as a major innovation, emphasizing that the medication acted on an entirely different mechanism within the brain than the previous generation of insomnia medicines like Ambien and Lunesta. During the drug's development, Merck had suggested that it could treat insomnia more effectively and produce fewer side effects than existing medications. In 2012, one Merck scientist described the science underlying Belsomra as a "sea change."

But when Schwartz and her colleagues scrutinized data from the company's own large-scale clinical trials, what they found was a lot less impressive. People taking Belsomra fell asleep, on average, only six minutes sooner than people taking a placebo and stayed asleep for a mere 16 minutes longer. Some test subjects experienced worrying side effects, like next-day drowsiness and temporary paralysis upon waking. For a number of people, these effects were so severe that the researchers halted their driving tests, fearing someone would get into an accident. Because of these safety concerns, the FDA ended up approving the drug at a lower starting dosage than the company had requested--a dosage so low that a Merck scientist admitted it was "ineffective."

So when Schwartz saw the Belsomra ad, she was struck by how smoothly it sidestepped the drug's limitations. A soothing voiceover hypes the science, giving a sophisticated explanation of how Belsomra targets a neurotransmitter called orexin to turn down the brain's "wake messages." "Only Belsomra works this way," the voice continues. The ad ends with the young woman curling up with the "sleep" animal and falling into a peaceful slumber. "You have no idea watching that ad that we're talking about falling asleep 6 minutes faster and staying that way an extra 16 minutes--and that's at higher doses," Schwartz said. "We really don't have a great idea of how well it works at the lower dose FDA actually recommends for people starting the medication."

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