Pharmaceutical company Pernix Therapeutics Holdings Inc announced positive final results from a Phase IV Study assessing the effects of nighttime administration of insomnia treatments, Silenor 6 mg and zolpidem 10 mg, as well as placebo, on arousability, gait, balance, and cognitive performance, after going to sleep, in healthy male volunteers. These data were presented at the SLEEP 2016 meeting.
The study assessed the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective Tmax (time the maximum serum concentrations are observed) in normal healthy adult male volunteers (n=52). The results of the study demonstrated that Silenor 6 mg was statistically superior to zolpidem 10 mg on the measures studied—arousability, gait, balance, and memory.
John Sedor, Pernix Therapeutics chairman and CEO, says in a release: “The results of this head-to-head study further support certain key benefits of Silenor 6 mg. Pernix is encouraged by these data and the impact they could have on the sleep community and patients.”
The results also indicated that subjects taking Silenor 6 mg did not have impairment on arousability, gait, balance, and cognitive performance, and were comparable to placebo. Further, in addition to Silenor 6 mg, both placebo groups were also statistically superior to zolpidem on the measures evaluated, indicating that zolpidem subjects had statistically significant difficulty in waking up, with walking and balance and with memory. Finally, there were no differences in efficacy measures between zolpidem 10 mg and Silenor 6 mg, while several measures were significantly improved with Silenor 6 mg versus placebo.
“One of the most interesting findings in the study was that a majority of the subjects in the zolpidem group did not wake up until they were exposed to noise of at least 110 decibels (dB; 64%),” says Heith Durrence, PhD, sleep expert and medical director at Pernix Therapeutics. “The awakening threshold data indicate that subjects taking zolpidem could have difficulty waking up to noises similar to a jackhammer (average of 100 dB), a potentially serious issue.”
