Review of: Maras A et al, J Child Adolesc Psychopharmacol 2018;28(10):699–710

Treating sleep problems in youth with autism spectrum disorder (ASD) is tricky at best. One promising treatment is pediatric prolonged-release melatonin ­(PedPRM) sold under the name Slenyto. In 2017, a randomized controlled trial (funded by the manufacturer) assigned 119 children with ASD and insomnia to either PedPRM (n = 58) or placebo (n = 61). PedPRM outperformed placebo: 68.9% of patients taking the medication had improved sleep outcomes vs only 39.3% of those assigned to placebo (p = .001).

Now a new article has been published to determine whether PedPRM maintains its effectiveness over the long term. A total of 95 patients entered this open-label phase, and 84% (n = 80) completed the phase. The average age of the patients was 9 years, and 75% were male. Youths previously randomized to placebo were switched to PedPRM and titrated to a maximum dose of 10 mg/day.

After 37 weeks, children originally randomized to and maintained on PedPRM showed sustained improvements: shorter sleep latency, greater length of sleep, fewer awakenings, and better sleep quality. In addition, those who previously received placebo showed improvement in sleep length and onset after switching to PedPRM. Caregivers’ quality of life improved as well, with 49% of caregivers experiencing an improvement on the quality-of-life scale used in the study.

The most common side effect of PedPRM was daytime fatigue, which occurred in 18% of the patients. There were no serious adverse events attributed to the medication, including aggression.

CCPR’s Take
This industry-funded study reports compelling results, which begs us to presume bias despite what appears to be sound methodology. It would be helpful to see a head-to-head study vs over-the-counter melatonin, which is cheaper albeit with less reliable pill-to-pill variability.

Still, PedPRM may be a viable treatment option for children with autism and insomnia who have failed a comprehensive sleep hygiene approach including attention to sensory issues, daily exercise, and psychotherapy, all of which might be effective in this population.