Therapeutic role of melatonin in fibromyalgia: A systematic review

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Created On: 21/08/2025

Melatonin—a hormone primarily implicated in sleep regulation—has emerged as a potential treatment to alleviate fibromyalgia-linked symptoms.

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Key take away

Melatonin effectively alleviates the key symptoms of fibromyalgia with a favorable safety profile.

Background

Melatonin—a hormone primarily implicated in sleep regulation—has emerged as a potential treatment to alleviate fibromyalgia-linked symptoms. This systematic review investigated melatonin's therapeutic effectiveness and safety in managing the symptoms associated with fibromyalgia.

Method

A comprehensive literature search was carried out across PubMed, Embase, Scopus, and the Cochrane Library to identify randomized controlled trials (RCTs), observational studies, case reports, and abstracts evaluating melatonin in individuals diagnosed with fibromyalgia. Data pertaining to outcomes like pain, sleep disturbances, anxiety, depression, fatigue, and stiffness were collected and analyzed according to PRISMA guidelines, utilizing a range of validated assessment tools.

Outcome measures included visual analog scale (VAS) for general wellness, the Numeric Pain Scale (NPS) for pain intensity, the State-Trait Anxiety Inventory (STAI) for anxiety, the Fibromyalgia Impact Questionnaire (FIQ), health-related quality of life (HRQOL) for quality of life, and the Pittsburgh Sleep Quality Index (PSQI) for sleep quality.

Result

From an initial pool of 852 records, 6 studies involving a total of 151 patients—most of whom were women—met the inclusion criteria. Across the outcomes ascertained, melatonin treatment was associated with notable improvements in pain, mood, sleep quality, social engagement, and overall well-being.

Conclusion

Melatonin appears to offer meaningful clinical benefits in fibromyalgia management by decreasing pain and anxiety and improving sleep and quality of life. With a good safety profile, it holds promise as an adjunct therapy, although further large-scale, rigorously designed trials are warranted to validate these outcomes.