[Note: to read the full text of this article free, click HERE. Trazodone is an old second-generation antidepressant/anti-anxiety medication with strong sedative activity; little studied for treating insomnia in non-depressed subjects yet frequently used (and recommended by the American Pain Society) for FM patients’ sleep problems. "Open label" means the subjects in this study knew they were taking trazodone; it was not placebo controlled.]
Background: Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study we have 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's 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.
Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well as sleep quality, sleep duration and sleep efficiency.
Significant improvements, 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.
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.
Trial registration: This trial has been registered with ClinicalTrials.gov number NCT-00791739.
Source: BMC Musculoskeletal Disorders, Sep 10, 2010;11:204. PMID: 20831796, by Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, Rico-Villademoros F, Calandre EP. Institute of Neurosciences and Center of Biomedical Research, University of Granada, Spain. [Email: Prof. Elena Calandre, MD, firstname.lastname@example.org]