BALTIMORE – Tasimelteon, a drug approved for non–24-hour sleep-wake disorder, has been shown to increase sleep times in travelers with jet lag, according to results from a phase 3 trial.
“Tasimelteon demonstrated an increase in total sleep time of 85 minutes versus placebo and also demonstrated improvement in next-day alertness versus placebo,” Christos Polymeropoulos, MD, medical director of Vanda Pharmaceuticals, said in presenting results of theduring the late-breaking abstracts session at the annual meeting of the Associated Professional Sleep Societies.
Tasimelteon, sold under the trade name Hetlioz, is a melatonin receptor agonist that is Food and Drug Administration–approved for non-24-hour sleep-wake disorder – but not for treatment of jet lag disorder (JLD). Dr. Polymeropoulos noted there is no FDA-approved treatment for JLD.
“Jet lag disorder is a circadian disorder frequently observed in millions of travelers who cross multiple time zones,” Dr. Polymeropoulos said. “JLD is characterized by nighttime sleep disruption, decrease in daytime alertness, and impairment in social and occupational function.”
JET8 induced the circadian challenge equivalent to crossing eight time zones. The study involved 318 individuals randomized evenly to 20 mg tasimelteon or placebo 30 minutes before bedtime. The primary endpoint of the study was total sleep time in the first two-thirds of night measured by polysomnography.
Those on tasimelteon averaged 216.4 minutes of total sleep time in the first two-thirds of night versus 156.1 for those on placebo (P less than .0001), Dr. Polymeropoulos said. Full total sleep times were 315.8 minutes versus 230.3 minutes (P less than .0001), respectively.
“For total sleep time, the tasimelteon subjects gained about an hour and a half, as measured by PSG [polysomnography],” Dr. Polymeropoulos said.
Other key markers the trial measured were latency to persistent sleep and wakefulness after sleep onset. They measured 15 minutes less and 74.6 minutes less, respectively, in the tasimelteon arm.
Dr. Polymeropoulos also disclosed early results of a second trial of tasimelteon in JLD: the JET Study, a two-phase transatlantic travel study of 25 patients. The subjects flew from four U.S. cities to London for 3 nights, receiving tasimelteon or placebo each night in London. The study was terminated before reaching its enrollment goal of 90 patients because of its complexity, Vanda said in a separate press release. Over 3 nights of study, the tasimelteon arm gained a total of about 130 minutes of sleep versus 40 minutes for the placebo arm, Dr. Polymeropoulos said.
Vanda has said it plans to file a supplemental new drug application for tasimelteon for treatment of JLD in the second half of this year.
Dr. Polymeropoulos is an employee of Vanda Pharmaceuticals.