Introduction and objectives. More than half of tinnitus patients suffer from mood disorders, irritability, stress or have difficulties to fall asleep, which further deteriorates their quality of life. The objective of this study was to evaluate the efficacy, tolerability and treatment adherence to a combination with 5-hydroxytryptophan, zinc, melatonin, Ginkgo biloba, magnesium and vitamin B5 and B6 (Tinnitan Duo®), as well as its effect on mood (anxiety and depression), in the treatment of patients with tinnitus. Methods. Observational, prospective and multicentre study conducted on 470 tinnitus patients who had been prescribed Tinnitan Duo®. Patients were assessed at baseline and after 90 days of treatment. We measured the changes in tinnitus intensity -Visual Analog Scale ([VAS]: 0-10)-, in quality of life -Tinnitus Handicap Inventory (THI) and in anxiety and depression-Goldberg Anxiety and Depression Scale (GADS). Results. There was a significant reduction ((p <0.001) in tinnitus intensity, measured by VAS (6.1 to 4.1), and in the THI scores (41.7 to 26.6). Also, a significant decrease was observed in each subscale of the GADS, anxiety-subscale (3.8 to 1.9) and depression-subscale (2.1 to 1.0). Better medication adherence was associated with greater improvement in all efficacy variables. Adverse events were observed in 17 patients (21%), none of which were serious. Conclusions. Tinnitan Duo® could be an effective and safe therapeutic alternative for patients with tinnitus. Further studies are necessary in order to determine whether these results persist after a longer period of time.