Delayed sleep phase syndrome: A placebo‐controlled cross‐over study on the effects of melatonin administered five hours before the individual dim light melatonin onset

Abstract

SUMMARYIn a double-blind placebo-controlled cross-over study, 30 patients with Delayed Sleep Phase Syndrome (DSPS) were included, of whom 25 finished the study. Melatonin 5 mg was administered during two weeks in a double-blind setting and two weeks in an open setting successively or interrupted by two weeks of placebo. The study's impact was assessed by measurements of the 24-h curves of endogenous melatonin production and rectal temperature (n=14), polysomnography (n=22), actigraphy (n=13), sleep log (n=22), and subjective sleep quality (n=25). Mean dim light melatonin onset (DLMO) (±SD), before treatment, occurred at 23.17 hours (±138 min). Melatonin was administered five hours before the individual DLMO. After treatment, the onset of the nocturnal melatonin profile was significantly advanced by approximately 1.5 hour. Body temperature trough did not advance significantly. During melatonin use, actigraphy showed a significant advance of sleep onset and polysomnography, a significant decreased sleep latency. Sleep architecture was not influenced. During melatonin treatment patients felt significantly more refreshed in the morning. These results show that analysis of DLMO of patients suffering from DSPS is important both for diagnosis and therapy. These results are discussed in terms of the biochemistry of the pineal.

Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders

“…We included nineteen studies involving a total of 1683 subjects in this meta-analysis [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39]. From the search on Pubmed and related bibliography above described 268 studies were selected.…”

Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders

“…It is particularly common in adolescents and can be also associated with depression. [67,68] Meta-analysis of the two eligible trials [52,53] investigating the role of melatonin in treating DSPS demonstrated an overall significant improvement in sleep onset latency compared with placebo (total mean difference = -22.05 minutes, 95% CI: -32.02, -12.09). The overall estimated score of melatonin treatment was significant (Z=4.34, P<0.0001) (Fig.3).…”

“…Melatonin facilitates achieving better sleep for these patients by reducing the sleep-onset latency [73] or by regulating sleep-wake times to coincide with the natural circulatory cycle, as well as reducing sleep episodes without muscle atonia. [50] The mechanism by which the occurrence of reducing sleep episodes without muscle atonia in RBD is still unknown and requires further study.…”

Circadian Rhythm Sleep Disorders

“…Melatonin is a nutritional supplement and is not regulated by the Food and Drug Administration (FDA), but is approved for use in treating sleep disorders. Studies involving melatonin are limited by the small number of participants, but studies have shown that administering melatonin (5 mg) 5 hours before sleep onset resulted in advancing sleep onset time [23][24][25].…”