US FDA Converges With Other Regulators On Insomnia Drug Warnings, But Broader Safety Disagreements Persist

US FDA will add boxed warnings to insomnia drugs, bringing it in line with other regulators, even as a study in JAMA Internal Medicine study indicates that national drug authorities often disagree more broadly over when to issue safety advisories.

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A set of insomnia drugs will come with more restrictive labeling.

Despite a broader trend of disagreement among national pharma regulators over instances for which to issue drug safety alerts, there appears to be some degree of convergence on warnings regarding certain insomnia drugs.

The US Food and Drug Administration issued a drug safety communication on 30 April announcing that it would be adding boxed warnings to the labels and Medication Guides of certain Rx insomnia drugs following reports of serious injury or death

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