Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. 2010

Piedad Morillas-Arques, and Carmen Ma Rodriguez-Lopez, and Rocio Molina-Barea, and Fernando Rico-Villademoros, and Elena P Calandre
Instituto de Neurociencias y Centro de Investigaciones Biomédicas, Universidad de Granada, Granada, Spain. calandre@gmail.com.

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.

UI MeSH Term Description Entries
D006993 Hypnotics and Sedatives Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. Hypnotic,Sedative,Sedative and Hypnotic,Sedatives,Hypnotic Effect,Hypnotic Effects,Hypnotics,Sedative Effect,Sedative Effects,Sedatives and Hypnotics,Effect, Hypnotic,Effect, Sedative,Effects, Hypnotic,Effects, Sedative,Hypnotic and Sedative
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D005260 Female Females
D005356 Fibromyalgia A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95) Diffuse Myofascial Pain Syndrome,Fibrositis,Rheumatism, Muscular,Fibromyalgia, Primary,Fibromyalgia, Secondary,Fibromyalgia-Fibromyositis Syndrome,Fibromyositis-Fibromyalgia Syndrome,Myofascial Pain Syndrome, Diffuse,Fibromyalgia Fibromyositis Syndrome,Fibromyalgia-Fibromyositis Syndromes,Fibromyalgias,Fibromyalgias, Primary,Fibromyalgias, Secondary,Fibromyositis Fibromyalgia Syndrome,Fibromyositis-Fibromyalgia Syndromes,Fibrositides,Muscular Rheumatism,Primary Fibromyalgia,Primary Fibromyalgias,Secondary Fibromyalgia,Secondary Fibromyalgias,Syndrome, Fibromyalgia-Fibromyositis,Syndrome, Fibromyositis-Fibromyalgia,Syndromes, Fibromyalgia-Fibromyositis,Syndromes, Fibromyositis-Fibromyalgia
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D012893 Sleep Wake Disorders Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle. Sleep Disorders,Long Sleeper Syndrome,Short Sleep Phenotype,Short Sleeper Syndrome,Sleep-Related Neurogenic Tachypnea,Subwakefullness Syndrome,Disorder, Sleep,Disorder, Sleep Wake,Disorders, Sleep,Disorders, Sleep Wake,Long Sleeper Syndromes,Neurogenic Tachypnea, Sleep-Related,Neurogenic Tachypneas, Sleep-Related,Phenotype, Short Sleep,Phenotypes, Short Sleep,Short Sleep Phenotypes,Short Sleeper Syndromes,Sleep Disorder,Sleep Phenotypes, Short,Sleep Related Neurogenic Tachypnea,Sleep Wake Disorder,Sleep-Related Neurogenic Tachypneas,Sleeper Syndrome, Long,Sleeper Syndrome, Short,Sleeper Syndromes, Long,Sleeper Syndromes, Short,Subwakefullness Syndromes,Syndrome, Long Sleeper,Syndrome, Short Sleeper,Syndrome, Subwakefullness,Syndromes, Long Sleeper,Syndromes, Short Sleeper,Syndromes, Subwakefullness,Tachypnea, Sleep-Related Neurogenic,Tachypneas, Sleep-Related Neurogenic,Wake Disorder, Sleep,Wake Disorders, Sleep
D014196 Trazodone A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309) AF-1161,Apo-Trazodone,Deprax,Desyrel,Gen-Trazodone,Molipaxin,Novo-Trazodone,Nu-Trazodone,PMS-Trazodone,Ratio-Trazodone,Thombran,Tradozone,Trazodon Hexal,Trazodon-Neuraxpharm,Trazodone Hydrochloride,Trazon,Trittico,AF 1161,AF1161,Apo Trazodone,Gen Trazodone,Novo Trazodone,Nu Trazodone,PMS Trazodone,Ratio Trazodone,RatioTrazodone,Trazodon Neuraxpharm,TrazodonNeuraxpharm

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