Rozerem shows efficacy as transient insomnia drug

Data presented at the 20th anniversary meeting of the Associated Professional Sleep Societies shows that Rozerem (ramelton), under development by Takeda Pharmaceuticals North America, a subsidiary of Japan's Takeda, reduced the time taken to fall asleep without any residual psycomotor or memory effects.

The study, which utilized a first-night-model of transient insomnia, enrolled 289 patients who were randomized to receive 8mg, 16mg or placebo, 30 minutes before bedtime. Patient sleep patterns were assessed using overnight polysomnography, which allowed the monitoring of brain activity during sleep.

The results showed that patients taking the lowest dose of the drug experienced a significant decrease in time taken to fall asleep, in comparison with placebo (12.7 minutes versus 19.7 minutes). The higher dose of the drug did bring about a reduction in the time to sleep, but not to a level of statistical significance.