FDA Approves Hetlioz to Treat Sleep Disorder in Blind

The U.S. Food and Drug Administration has given the nod to a new drug Hetlioz to treat sleep disorders in blind individuals. This is the first drug approved by FDA to treat the non-24 hour sleep wake disorder.

FDA announced Friday, the release of Hetlioz, a melatonin receptor agonist that is intended to cure the non 24 hour sleep wake disorder in blind individuals. The newly approved drug is manufactured by Vanda Pharmaceuticals, Inc.

The non-24 hour sleep wake syndrome is a neurological sleep disorder that occurs in people who are totally blind and who lack sensitivity to light that is required to reset the body circadian rhythm. This disorder in the blind triggers problems with sleep timings.

"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. "Hetlioz can improve the ability to sleep at night and to be active during the day." 

 There are cases where people with complete blindness can still see light that is sufficient enough to avoid the disorder. But there are close to 100,000 Americans who are still living with this condition that cannot see light that is required for a normal night sleep schedule. This disorder can occur in people of any age group.

To test the safety and effectiveness of the drug, a test was conducted on 104 participants in two clinical trials.  The participants were totally blind and were victims of the non 24-hour sleep disorder. The participants were randomly given either a placebo or the new drug Hetlioz.

The researchers saw that the participants, who were given the new drug Hetlioz, noticed an improvement in both increased night time sleep and a drop in the daytime sleep duration.

The side effects reported by the participants varied from headaches to nightmares, upper respiratory or urinary tract infection, drowsiness and high liver enzymes in blood.  The drug also impaired activities that needed sound mental alertness.

According to FDA, the drug should be taken during the night before bedtime and the person should reduce the activities after consumption of the drug. Since this drug is used to cure a rare disease it received the orphan-product designation.