Trazodone for the treatment of fibromyalgia: an open-label, 12-week study.
BACKGROUND
Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia.


METHODS
A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement Scale (PGI). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test.


RESULTS
Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients.


CONCLUSIONS
In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored.


BACKGROUND
This trial has been registered with ClinicalTrials.gov number NCT-00791739.
Morillas-Arques
Piedad
P
Instituto de Neurociencias y Centro de Investigaciones Biomédicas, Universidad de Granada, Granada, Spain. calandre@gmail.com.
Rodriguez-Lopez
Carmen Ma
CM
Molina-Barea
Rocio
R
Rico-Villademoros
Fernando
F
Calandre
Elena P
EP
D000328:Adult; D000368:Aged; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014196:Trazodone / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D006993:Hypnotics and Sedatives; D017367:Selective Serotonin Reuptake Inhibitors; D014196:Trazodone