Pilot Study on the Effect of Ramelteon on Sleep Disturbance After Traumatic Brain Injury: Preliminary Evidence From a Clinical Trial.

Abstract:

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 crossover 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 >5. INTERVENTIONS:A nightly dosage of ramelteon (8 mg) was given over a period of 3 weeks. MAIN OUTCOME MEASURES:An actigraph and a daily sleep log were used to measure sleep/wake patterns. Daytime functioning was measured after 3 weeks of treatment using a computer-administrated neuropsychological test battery 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 3 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 8 mg of ramelteon taken nightly over a 3-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.

journal_name

Arch Phys Med Rehabil

authors

Lequerica A,Jasey N,Portelli Tremont JN,Chiaravalloti ND

doi

10.1016/j.apmr.2015.05.011

subject

Has Abstract

pub_date

2015-10-01 00:00:00

pages

1802-9

issue

10

eissn

0003-9993

issn

1532-821X

pii

S0003-9993(15)00423-2

journal_volume

96

pub_type

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