FDA Approves ‘Hetlioz’ Treatment for Sleeping Disorder of Blind Patients

The U.S. Food and Drug Administration have recently approved the first ever treatment called Hetlioz for blind individuals suffering from a sleeping disease referred to as non-24-hour sleep-wake disorder.

For blind individuals, light cannot enter their eyes thereby interrupting a natural reflex of the body to wake up or seek rest. They are incapable to follow a 24-hour light-dark cycle and may experience difficulty getting sound sleep and eventually wake up in the morning feeling restless. Some suffer a reversal of their sleeping patterns: instead of waking up in the morning, they recognize the night as time for a bowl of cereal.

"Non-24- hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted," said Eric Bastings, M.D, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a press release. "Hetlioz can improve the ability to sleep at night and to be active during the day."

Around 100,000 individuals residing in the United States have this condition as they cannot perceive enough light to guide their sleep receptors. Hetlioz of Vanda Pharmaceuticals, Inc. was evaluated in two clinical trials involving 104 completely blind individuals suffering from the sleeping disorder. It produced an impressive improvement relative to placebo in both cases of increasing sleep at night and decreasing sleep in the morning.

The researchers noted some side effects including headaches, increased liver enzymes (alanine aminotransferase) in the blood, nightmares and odd dreams, perturbed sleep, urinary tract or upper respiratory infection as well as drowsiness. They also observed that the drug can get in the way of daytime activities requiring full mental agility explaining why doctors suggest that it be taken at nighttime before going to bed or otherwise have limited activity after ingestion.

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