Ramelteon may be effective for the treatment of sleep disturbances after a traumatic brain injury (TBI), according to a pilot study published in the journal Archives of Physical Medicine and Rehabilitation.

Sleep problems are a major debilitating consequence affecting 30–70% of patients after TBI. Common treatments for sleep disturbance include antidepressants, antihistamines, and benzodiazepines, but these may have side effects like cognitive impairment. Researchers from the Kessler Foundation enrolled 18 TBI patients in a double-blind, placebo-controlled crossover trial in which they were followed up for five visits over nine weeks. Evaluations included the neuropsychological testing, sleep variables, and mood measures that were monitored using Actigraph, an electronic device that measures the rest/activity cycle of the participant and self-reported sleep logs. The outcomes measured were total sleep time (TST), sleep-onset latency (SOL), and cognitive functioning.

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With three weeks of treatment with ramelteon 8mg once-daily , TST increased with maximal effects seen after only one week of treatment. SOL was longer in TBI patients compared to the non-TBI population with a statistically significant increase of less than five minutes; however, this was not considered clinically significant. Cognition also improved after three weeks of treatment, measured by the CNSVS Neurocognitive Index, which showed that executive functioning was significantly improved.

Study author Anthony Lequerica, PhD concluded that these preliminary findings indicate that ramelteon may be useful for treating sleep-wake disturbances among individuals with TBI. Ramelteon is a melatonin-agonist currently approved for the long-term treatment of insomnia.

For more information visit KesslerFoundation.org