Petition to FDA Concerning the Inappropriately Expanded Approval of the Sleep Drug Tasimelteon (Hetlioz)

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Public Citizen petitions the Food and Drug Administration (FDA) to reverse its decision to expand the approval of the sleep medication tasimelteon (Hetlioz) to patients who are not blind, as the relevant clinical trials for the drug were conducted only in totally blind patients with non-24-hour sleep-wake disorder. The petition also requests that FDA include certain animal toxicity data in the drug’s label.

June 11, 2015, Acknowledgement letter from the FDA

December 7, 2015, interim response letter from the FDA.

January 27, 2020, FDA final response letter.