HealthDay News — The FDA has approved tasimelteon (Hetlioz) to treat a sleep disorder in the blind caused by inability to recognize light from dark to regulate the body’s circadian rhythm.
The condition is called non-24-hour sleep-wake disorder. Those affected — as many as 100,000 people in the United States — experience difficulty falling asleep or staying asleep, and may become groggy, the agency said in a press release.
Tasimelteon is a melatonin receptor agonist.The first FDA-approved treatment for the disorder, the treatment was given orphan product designation and was approved via priority review.
The safety and effectiveness of tasimelteon were evaluated in a clinical study involving 104 completely blind people with non-24-hour sleep-wake disorder.
Treatment with tasimelteon resulted in significant improvements compared to placebo, both in increasing nighttime sleep and decreasing daytime sleep duration. Reported side effects included drowsiness, 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.