BRIEF—Hetlioz effective in jet lag disorder

Vanda Pharmaceuticals says that Hetlioz (tasimelteon), a circadian regulator, has demonstrated significant and clinically meaningful benefits in night- and daytime symptoms of jet lag disorder.

Hetlioz is currently approved in the USA and Europe for the treatment of Non-24-hour sleep-wake disorder, a rare and chronic circadian rhythm sleep disorder.

Jet lag disorder is a common circadian disorder frequently observed in millions of travelers who cross multiple time zones. Jet lag disorder is characterized by night-time sleep disruption, a decrease in daytime alertness and impairment to social and occupational functioning.

The clinical efficacy results reported today are from the JET8 Phase III clinical study (3107) (the JET8 study). In the JET8 study, 318 healthy volunteers were admitted to a sleep unit and were subjected to a circadian challenge of an 8 hours advance to their usual bedtime.

The JET8 study design induced the circadian challenge experienced by travelers who cross 8 times zones, which leads to jet lag disorder.

This clinical design allowed for the study of Hetlioz without the confounding effects of sleep deprivation and variable light conditions.