FDA clears first drug for blindness sleep disorder

January 31, 2014

U.S. health regulators have approved a first-of-a-kind drug to treat a sleep disorder that mainly afflicts the blind.

The Food and Drug Administration approved Hetlioz capsules for patients who have problems sleeping because they can't detect light. The condition, called non-24-hour disorder, is estimated to affect up to 100,000 Americans, most of whom are totally blind. Hetlioz is the first FDA-approved treatment for the condition.

The most common side effects of the drug include headache, nightmares and respiratory and . The drug labeling warns that Hetlioz causes drowsiness and can interfere with performing basic tasks and mental alertness.

Analysts estimate the drug's annual sales could exceed $350 million.

Washington DC-based Vanda Pharmaceuticals markets one other drug for schizophrenia.

Company shares rose nearly 5 percent in afternoon trading.

Explore further: FDA adds most severe warning to Pfizer's Tygacil

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