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 III trial. “Tasimelteon demonstrated an increase in total sleep time of 85 minutes versus placebo and also demonstrated improvement in next-day alertness versus placebo,” said Christoph Polymeropoulos, MD, Medical Director of Vanda Pharmaceuticals, and colleagues at the 32nd Annual Meeting of the Associated Professional Sleep Societies.
Tasimelteon, sold under the trade name Hetlioz, is a melatonin receptor agonist that is FDA-approved for non–24-hour sleep-wake disorder but not for the treatment of jet lag disorder. Dr. Polymeropoulos noted that there are no FDA-approved treatments for jet lag disorder.
“Jet lag disorder is a circadian disorder frequently observed in millions of travelers who cross multiple time zones,” Dr. Polymeropoulos said. “Jet lag disorder is characterized by nighttime sleep disruption, decrease in daytime alertness, and impairment in social and occupational function.”
The JET8 trial 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 end point of the study was total sleep time in the first two-thirds of sleep time, as measured by polysomnography.
Those on tasimelteon averaged 216.4 minutes of total sleep time in the first two-thirds of their sleep time versus 156.1 minutes for those on placebo, Dr. Polymeropoulos said. Total sleep times were 315.8 minutes versus 230.3 minutes, respectively. “For total sleep time, the tasimelteon subjects gained about an hour and a half, as measured by 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 jet lag disorder: the JET Study, a two-phase transatlantic travel study of 25 patients. The subjects flew from four US cities to London for three 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 three nights of study, participants in the tasimelteon arm gained a total of about 130 minutes of sleep versus 40 minutes for those in the placebo arm, Dr. Polymeropoulos said.
Vanda plans to file a supplemental new drug application for tasimelteon for the treatment of jet lag disorder in the second half of this year.
—Richard Mark Kirkner
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