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Another Reckless FDA Action: Approval of Suvorexant (Belsomra)

Statement of Dr. Sammy Almashat, Researcher, Public Citizen’s Health Research Group

The U.S. Food and Drug Administration’s (FDA) decision to approve suvorexant (brand name: Belsomra) will surely worsen the public health crisis caused by the proliferation of dangerous and habit-forming sleep medications over the past two decades.

In addition to flying in the face of the FDA’s recent but belated attempts to mitigate the high numbers of deaths and injuries resulting from traffic accidents induced by these medications, Wednesday’s decision is troubling in its own right. The lowest doses of suvorexant were approved by the agency despite having never been tested in large clinical studies that are a standard requirement for all modern medication – and dosage – approvals, while the higher doses demonstrated only marginal benefits.

Like its predecessors, suvorexant was found to cause severe next-day driving impairment, prompting the FDA to caution patients against driving or engaging in other activities requiring “full mental alertness” the following morning.

However, for a medication indicated for daily and long-term use, this is an obviously unrealistic request and one that will unfortunately fail to prevent the inevitable harm to both patients and the public.

For more information, see Public Citizen’s May 2013 FDA advisory committee testimony and June 2013 letter to the FDA opposing the approval of suvorexant.