Kessler researchers found preliminary evidence for the effectiveness of ramelteon for the treatment of sleep disturbances after traumatic brain injury (TBI). The article was e-published ahead of print in the Archives of Physical Medicine and Rehabilitation.
Sleep problems affect 30% to 77% of individuals with brain injury, affecting recovery and their ability to participate in rehabilitation. Mood disorders, fatigue, and poor occupational outcomes are more common among people with sleep difficulties post-TBI. Medications commonly used in treating sleep disturbance, including antidepressants, antihistamines, and benzodiazepines, often have side effects that impair cognition. Ramelteon is a melatonin-agonist without the risks for dependence or addiction. Although it is approved for long-term treatment of insomnia, ramelteon had not been studied in this population.
Eighteen people with TBI were enrolled in this double-blind, placebo-controlled, crossover trial. They completed 5 visits over 9 weeks; evaluations include neuropsychological testing, sleep variables, and mood measures. Participants were monitored using actigraph as well as by self report (sleep log). Outcomes measured included total sleep time, sleep-onset latency, and cognitive functioning.
As in the non-TBI population, total sleep time increased with 3 weeks of ramelteon 8 mg before bedtime, with maximal effectiveness achieved after 1 week of treatment. The TBI population responded differently in terms of sleep-onset latency, taking a few minutes longer to fall asleep on ramelteon. Although statistically significant, the increase was less than 5 minutes on average and not considered clinically significant. Cognition improved after 3 weeks of treatment, evidenced by improvement on the CNSVS Neurocognitive Index derived from a neuropsychological battery delivered via computer. A significant improvement was noted on the executive functioning subtest with marginally significant improvement in reaction time.
"Ramelteon increased the total time asleep and seemed to bring more order or consistency to the sleep-wake cycles. These preliminary findings indicate that ramelteon may be useful for treating sleep-wake disturbances among individuals with TBI," said Dr Lequerica, clinical research scientist in TBI Research at Kessler Foundation. "It may be optimal to begin ramelteon during acute care," he noted. "By addressing sleep issues before rehabilitation starts, we can optimize the person's ability to engage in rehabilitative therapies."
This study was funded by the New Jersey Commission on Brain Injury Research (10-3222-BIR-E-0).
Source: News Release
August 20, 2015