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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.
Non-24 occurs in persons who are completely blind. Light does not enter their eyes and they cannot synchronize their body clock to the 24-hour light-dark cycle.
Those with the disorder may have difficulty falling asleep or staying asleep, and may wake up groggy or feeling as if they need more rest. People with non-24 may find their sleep patterns reversed -- needing to sleep during the day and to be awake at night.
Although most people who are totally blind still can perceive light well enough to prevent non-24, there may be as many as 100,000 individuals in the United States with this condition, who can’t perceive enough light to establish a normal night sleep schedule. Non-24 can occur at any age.
For more information, please visit: Hetlioz
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