Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
Study Goal
The researchers aimed to evaluate the efficacy and safety of prolonged-release melatonin mini-tablets (PedPRM) in improving sleep duration and onset in children with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia, as well as its effects on child behavior and caregiver quality of life.
Results Summary
PedPRM significantly improved externalizing behavior (but not internalizing behavior) and caregivers' quality of life compared to placebo, with clinically relevant improvements in 53.7% of treated subjects versus 27.6% in the placebo group. The treatment also alleviated insomnia-related difficulties in children.
Population
Children aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia.
Effective Dosage
2-5 mg (prolonged-release mini-tablets).
Duration
13 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2-5 mg) | increase | sleep duration and onset | 125 subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia | - | demonstrated efficacy in improving | #1 |
PedPRM treatment | increase | externalizing behavior (Strengths and Difficulties questionnaire; SDQ) | subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia | - | resulted in significant improvement in | #2 |
PedPRM treatment | no change | internalizing behavior (Strengths and Difficulties questionnaire; SDQ) | subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia | - | resulted in no significant improvement in | #3 |
PedPRM treatment | increase | externalizing behavior | PedPRM-treated subjects | 53.7% | resulted in clinically-relevant improvements in | #4 |
placebo treatment | increase | externalizing behavior | placebo-treated subjects | 27.6% | resulted in clinically-relevant improvements in | #5 |
PedPRM treatment | increase | caregivers' quality of life | caregivers of subjects with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia | - | improved | #6 |
PedPRM | decrease | insomnia-related difficulties | children with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia | - | alleviates | #7 |
A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2-5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver's quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers' quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers' quality of life.