According to the researchers, the experimental drug, called tasimelteon, also known as VEC-162, mimics the effects of melatonin, the so-called sleep hormone, thus helping people cope with disrupted sleep-wake cycles, as are found with jet lag or rotating work shifts.
In separate phase II and phase III studies, the drug tasimelteon developed by Maryland-based Vanda Pharmaceuticals Inc. showed promise in helping sufferers sleep longer and more deeply than a placebo.
"By simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms, tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers," said authors of the study.
To reach their findings, a team of researchers headed by Dr. Elizabeth B. Klerman, M.D., Ph.D., of Brigham and Women's Hospital, carried out two studies in which they monitored 450 people who were subjected to simulated jet lag in a sleep laboratory.
In the first, 411-person phase III study, scientists gave the study subjects three dosage levels of tasimelteon as well as placebo. Volunteers in this group took the pill or a placebo for a week, 30 minutes before bed in a hospital.
Dr. Elizabeth and colleagues found that taking the new drug allowed patients to fall asleep faster and stay asleep for longer, compared to those who received placebo. Also, people on drug did not experience any aftereffects from the drug, and performed normally the next day, said the authors of the study.
In the second, 39-person phase II study, which had the same approach, researchers monitored the patients' normal sleep habits for three nights in the laboratory before they were sent to bed five hours early. They found that the participants who were given tasimelteon spent 80 percent to 90 percent of their time asleep, compared with 70 percent of those given a placebo.
People who took the drug also gained 35 minutes to 104 minutes more rest. In addition, it took them an average of seven minutes to go to sleep, compared with 11 minutes before the trial and 22 minutes for those given a placebo.
Meanwhile, in an accompanying editorial, Dr. Daniel Cardinali of the University of Buenos Aires and Dr Diego Golombek, National University of Quilmes in Argentina, said: "Shift-workers, airline crew, tourists, football teams, and many others will welcome” the findings of the studies.
Dr. Elizabeth said that unlike conventional sleeping aids such as Ambien or Lunesta, the new drug tasimelteon has no potential for addiction or abuse.
The findings of Phase II and III of the study were published online in the Lancet medical journal.
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