Use of melatonin to treat sleep disorders in tuberous sclerosis

The results of a therapeutic trial of the use of melatonin in patients with tuberous sclerosis complex who also have severe sleep problems are reporte d. We used a randomized double-blind placebo-controlled crossover design. S even patients with confirmed diagnoses of tuberous sclerosis and significan t sleep disorder were recruited. We employed three outcome measures: total sleep time, time to sleep onset, and number of awakenings. Patients treated with melatonin had a small but clinically significant improvement in total sleep time (mean improvement 0.55 hours, P<0.05). They also tended to have an improvement in sleep-onset time but this did not reach statistical sign ificance. Melatonin, in this trial, had no discernible effect on sleep frag mentation. We conclude that melatonin does have a beneficial effect in prol onging the total sleep time of patients with tuberous sclerosis and sleep d isorder and that further trials are necessary to investigate the issues of optimal dosage, tolerance, and possible interactions with other medications .