How FDA’s insomnia drug warning could impact prescribing

Gilmore

FDA’s new boxed warning on popular insomnia medications could have a negative impact on prescribing, some experts say.

The agency said the warning, which will be required for eszopiclone (Lunesta, Sunovion, Teva), zaleplon (Sonata, Pfizer) and zolpidem (Ambien, Sanofi Aventis, and other brands), will note that there are reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after using the drugs. “These complex sleep behaviors may include sleepwalking, sleep driving, and engaging in other activities while not fully awake, such as unsafely using a stove,” FDA said in a statement.

In addition to the boxed warning, FDA is requiring the addition of a contraindication to not use these medicines in patients who have experienced an episode of complex sleep behaviors after taking them.

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While the association between these drugs and complex sleep behaviors is already included in the label, the new boxed warning and contraindication are "intended to make the warning more prominent and reflect the risk of serious injury and death,” FDA said.

“A black box warning will further dampen the use of these treatments,” Peter Gilmore, a principal at KPMG Strategy, told FormularyWatch. However, sleep disorders are relatively under-treated so the impact on sales may not be significant, according to Gilmore. “If you look at the top categories of what is being prescribed, sleeping pills are nowhere near the top spending categories."

And Charline Shan, vice president of the Access Experience Team at Precision for Value, expects a minimal impact on how often the drugs will be prescribed. “The risks and adverse events associated with certain insomnia medications are known and documented,” he said. “Overall, given the rarity of the adverse events, impact to sales may be minimal. It comes down to benefits versus risk for patients who are suffering from insomnia."

The warning does raise awareness of rare and serious adverse events-especially for those that are new to therapy, Shan said.

“While the warning applies to medications that are available as generics, and cost to the patient is not a key consideration or hindrance to prescribing, it may cause prescribers to pause when determining treatment for newly diagnosed patients,” he said. “There is also a potential likelihood of patients not staying or using these medications for long term.”

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Patients and physicians should have candid discussions about the use of these drugs and where a benefit is being achieved, according to Gilmore. “Sleep disorders are increasingly found to have health consequences, including risks of obesity, anxiety, depression, and impaired glucose tolerance,” he said.

The new warning reveals an unmet medical need to improve sleep medications targeting the quality of sleep delivered, according to Gilmore.

“It definitely requires a lot more study about the nature of sleep and how a treatment can improve its restorative nature,” he said.

FDA reviewed 66 cases reported to the FDA Adverse Event Reporting System or found in medical literature, in which patients engaged in activities while they were not fully awake, such as sleepwalking or driving, that resulted in serious injuries or death.

FDA received 46 reports of non-fatal serious injuries, which included accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds, and apparent suicide attempts.

The 20 deaths reported were from carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide, FDA said in a statement.

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