0639 Tasimelteon Effective in Treating Jet Lag during Transatlantic Travel

Introduction Jet Lag Disorder (JLD) affects millions of individuals annually who cross multiple time zones during their travel. JLD symptoms are more severe during eastward travel. It is reported that there are more than 30 million US resident trips each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in Europe, the Middle East and Asia. Methods This was a two-phase transatlantic travel study, with an observational travel phase (baseline) followed by a treatment phase. 25 study participants traveled either 5 or 8 time zones from Washington, DC to London and San Francisco or Los Angeles to London, respectively. They stayed in London for 3 nights and 4 days, and during randomization they received tasimelteon 20mg for 3 consecutive nights prior to their bedtime. Efficacy was monitored by polysomnography (PSG) as well as sleep and wake questionnaire scales (PSQ). Results Tasimelteon significantly improved the primary endpoint in total sleep time of the first 2/3 (TST2/3) on Night 3 as measured by PSG (tasimelteon=76.2; placebo=41.4; p=0.0354). Tasimelteon also demonstrated significant improvement in the total sleep time at night 3 (tasimelteon=111.9; placebo=33.5; p=0.0225), sleep quality at night 3 (tasimelteon=1.31; placebo=0.36; p=0.0198), and sleep latency at night 3 (tasimelteon=-20.6; placebo=6.0; p=0.0347) as measured by the PSQ. In addition, Tasimelteon significantly improved the global function as measured by patient global impression of severity (PGI-S) (tasimelteon=-0.71; placebo=-0.07; p=0.0168). Conclusion The JET study successfully demonstrated clinically meaningful and statistically significant improvements in both objective and subjective sleep measures as well as global functioning after a real-world flight. These results suggest that tasimelteon can be an effective therapeutic tool to treat Jet Lag in the context of 5- and 8-hour time zone transatlantic travel. Support (If Any) This work was supported by Vanda Pharmaceuticals Inc.