The value of melatonin for sleep disorders occurring post-head injury: a pilot RCT.
OBJECTIVE
Whilst there is data to support the use of Melatonin in treating disorders of the sleep-wake cycle, so far there is little published evidence on the efficacy of Melatonin in treating the prevalent condition of post-TBI sleep disturbance.


METHODS
The present work used a randomized double-blind controlled cross-over trial to compare Melatonin (5 mg) and Amitriptyline (25 mg) in a small sample of TBI patients presenting with chronic sleep disturbance.


RESULTS
No differences in sleep latency, duration, quality or daytime alertness were found for either drug compared to baseline using significance testing. However, effect sizes revealed some encouraging changes. Patients on Melatonin reported improved daytime alertness compared to baseline. On Amitriptyline, patients reported increased sleep duration compared to baseline.


CONCLUSIONS
The study provides preliminary evidence for the value of Melatonin and Amitriptyline in treating sleep disorder post-TBI. There were no adverse drug effects. Suggestions are made for ongoing investigation for the treatment of this prevalent condition.
Kemp
Steven
S
The Leeds Head Injury Team, St. Mary's Hospital, Leeds, UK. steven.kemp@leedsth.nhs.uk
Biswas
Raja
R
Neumann
Vera
V
Coughlan
Anthony
A
D000293:Adolescent; D000328:Adult; D000639:Amitriptyline / Q000627:therapeutic use; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use; D000975:Antioxidants / Q000627:therapeutic use*; D003071:Cognition; D006259:Craniocerebral Trauma / Q000150:complications* / Q000534:rehabilitation; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D016896:Treatment Outcome
D000929:Antidepressive Agents, Tricyclic; D000975:Antioxidants; D000639:Amitriptyline; D008550:Melatonin