Abstract
Introduction:
Agomelatine, a melatonin agonist and selective 5-HT2C antagonist, is a novel antidepressant
with sleep-enhancing properties. The purpose of this study was to assess the efficacy
and tolerability of agomelatine among patients with fibromyalgia and depression.
Methods:
23 patients with fibromyalgia and depressive symptomatology received 25–50 mg of agomelatine
daily for 12 weeks. The primary outcome measure was the change of the Beck depression
inventory score. Secondary outcome measures included the hospital anxiety and depression
scale, Pittsburgh sleep quality index, Fibromyalgia Impact Questionnaire, short-form
health survey, brief pain inventory and patient’s global impression scale.
Results:
Agomelatine significantly improved depression, global fibromyalgia severity and pain
intensity but effect sizes were small. No improvement was seen in sleep quality. Patients
categorized as responders to treatment had milder disease severity than non-responders.
Agomelatine therapy was well tolerated and patients only reported mild and transient
side effects.
Discussion:
Agomelatine slightly improved depressive and fibromyalgia symptomatology but did not
improve sleep quality. Our data do not support agomelatine as a first-line treatment
option for the treatment of fibromyalgia and depression.
Key words
fibromyalgia - depression - agomelatine - sleep quality
