FDA Approves Hetlioz for Sleep Disorder in Blind People
Condition stems from inability to govern sleep from light-dark cycle
MONDAY, Feb. 3, 2014 (HealthDay News) -- Hetlioz (tasimelteon) has been approved by the U.S. Food and Drug Administration to treat a sleep condition caused by a completely blind person's inability to regulate the body clock by recognizing light from dark.
The condition is called non-24-hour sleep-wake disorder. Affected people may have difficulty falling asleep or staying asleep, and may become groggy, the agency said Friday in announcing the approval.
Up to 100,000 people in the United States have the disorder, the FDA said in a news release.
The safety and effectiveness of the new drug were evaluated in a clinical study of 104 completely blind people. Reported side effects included headache, elevated liver enzymes, unusual dreams, and infections of the upper respiratory or urinary tract.
The drug is produced by Vanda Pharmaceuticals, based in Washington, D.C.