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A Fixed Combination of Palmitoylethanolamide and Melatonin (PEATONIDE) for the Management of Pain, Sleep, and Disability in Patients with Fibromyalgia: A Pilot Study

Terribili R, Vallifuoco G, Bardelli M, Frediani B, Gentileschi S. Nutrients, 2024; 16(16):2785.

Open-label, no control groupHumansWith melatonin

This study tested palmitoylethanolamide together with melatonin. Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.

Design
Open-label, no control group
Subjects
50 patients with fibromyalgia. All completed.
Dose used in the study
1,200 mg of palmitoylethanolamide with 0.2 mg of melatonin, once a day at bedtime
Duration
3 months, then 1 month off treatment
What was measured
Pain on a visual analogue scale, an insomnia severity index, a disability questionnaire and tender point count.

What the authors reported

At 1 month pain fell by 1.16 points and the insomnia score improved by 6.24 points (both p < 0.01). Improvements held at 3 months and were partly kept after treatment stopped. No adverse events were reported.

Limits of this study

There was no control group, which the authors name as a limit. Melatonin is itself used for sleep, so the sleep result cannot be assigned to palmitoylethanolamide. The authors declared no conflicts. The funding statement was not visible on the page checked.

Source

doi:10.3390/nu16162785

Entry checked against the full text at the publisher (MDPI) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.