Twenty-four patients (mean age, 61 years) with tinnitus for a mean duration of 11.3 years received 3 mg/day of melatonin 1-2 hours before bedtime for four weeks, followed by four weeks of observation with no melatonin treatment. The Tinnitus Handicap Inventory (THI) and the Pittsburgh Sleep Quality Index (PSQI) were administered at baseline and after four and eight weeks. Compared with baseline, the mean THI score decreased (improved) significantly by 18.6% after four weeks and by 29.4% after eight weeks. The mean PSQI also improved after four weeks (p < 0.0001) and eight weeks (p = 0.0003). There was an association between the improvement in sleep and the improvement in tinnitus, but this association was significant only at four weeks. The impact of melatonin on sleep was greatest among patients with the worst sleep quality, but its impact on tinnitus was not associated with the severity of the tinnitus.

Comment: The results of this study indicate that melatonin may be an effective treatment for idiopathic tinnitus. Melatonin is known to improve sleep quality in some patients. However it is not clear whether the improvement in tinnitus in this study was due to better sleep or to some other mechanism. The improvement in tinnitus is noteworthy, because this condition is frequently refractory to treatment. Of note, tinnitus continued to improve after melatonin was discontinued and after the improvement in sleep resulting from melatonin therapy reverted partially back toward the baseline value during the second four-week period. This suggests that a four-week course of melatonin may have produced a lasting benefit.

Megwalu UC, et al. The effects of melatonin on tinnitus and sleep. Otolaryngol Head Neck Surg. 2006;134:210-213.