Research Reports - Pilot study on the effect of Ramelteon on sleep disturbance after traumatic brain injury
Arch Phys Med Rehabil. 2015 May 27
Lequerica A(1), Jasey N(2), Portelli Tremont JN(3), Chiaravalloti ND(4)
OBJECTIVE: To investigate the effect of ramelteon on sleep and daytime
functioning among individuals with traumatic brain injury (TBI).
DESIGN: A double blind placebo controlled study with a cross-over design.
SETTING: A research facility attached to an acute rehabilitation hospital.
PARTICIPANTS: Individuals with TBI (N=13) complaining of sleep difficulties with
a Pittsburgh Sleep Quality Index score greater than five.
INTERVENTIONS: A nightly dosage of ramelteon (8mg) was given over a period of
MAIN OUTCOME MEASURES: An actigraph and daily sleep log were used to measure
sleep/wake patterns along with a daily sleep log. Daytime functioning was
measured after three weeks of treatment using a computer-administrated
neuropsychological test battery (CNS Vital Signs software) in conjunction with
subjective questionnaires measuring mood, daytime sleepiness, and fatigue.
RESULTS: A significant increase in objectively measured total sleep time and a
small increase in sleep latency were observed after three weeks of treatment
compared with placebo. Treatment also showed a significant increase in
standardized neuropsychological test scores, with a particular improvement on an
index of executive functioning.
CONCLUSIONS: Preliminary evidence for the effectiveness of 8mg of ramelteon taken
nightly over a three week period was found in the treatment of sleep difficulties
among individuals with TBI. Improvements in total sleep time and some aspects of
cognitive functioning are discussed.