News Feature | February 6, 2014

The FDA Has Approved Hetlioz For Sleep-Wake Disorder

Source: BioProcess Online

By Cyndi Root

The Food and Drug Administration (FDA) announced in a press release that it has approved Hetlioz (tasimelteon) for non-24 hour sleep-wake disorder in blind patients. Vanda Pharmaceuticals, Inc. of Washington, D.C. manufactures Hetlioz. The FDA reviewed the drug under its priority review program, which expedites new drug applications that offer significant improvements for serious diseases or conditions. Hetlioz is also categorized as an orphan drug, as it treats a rare condition and it is the first FDA approval for this disorder.

Non-24 Hour Sleep-Wake Disorder

Non-24 hour (“non-24”) sleep-wake disorder is a body clock or circadian rhythm disorder. In blind people, it causes sleep disruption. Because the eyes cannot see light, the body refuses to submit to the regular light-dark cycle. Patients have trouble falling asleep, staying asleep, or wake unrested. Some people get totally off course and sleep during the day, but not at night. Additionally, poor sleep can lead to a host of other problems like poor eating habits and mood disorders.

Some blind people can see enough light so that sleep is not disturbed, but as many as 100,000 people in the U.S. have enough difficulty that finding treatment is important. Eric Bastings, M.D, Deputy Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said, “Non-24 hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted. Hetlioz can improve the ability to sleep at night and to be active during the day.”


Hetlioz is a melatonin receptor agonist. Clinical trials demonstrated its effectiveness in 104 study enrollees. Blind people with the non-24 disorder experienced significant improvement in nighttime sleep when treated with Hetlioz compared to a placebo. Participants also decreased daytime sleep. Some patients did experience side effects including headache, nightmares, upper respiratory and urinary tract infections, and elevated liver enzymes. Patients should be aware that some activities requiring mental alertness may be negatively affected by the drug. Dosage is every night before bedtime.

About Vanda Pharmaceuticals

Vanda Pharmaceuticals is a specialty biopharmaceutical company focused on central nervous system disorders. The company is working on bringing other drugs to the market including VLY-686 for pruritus and Fanapt for schizophrenia.