Melatonin for Kids with Autism: Does it Help Them Sleep?

clinical-trial PMID: 29096777

Quick Summary: A new study found that a special type of melatonin helped children and teens with autism spectrum disorder (ASD) sleep better. The melatonin, in a tiny tablet form, increased sleep time and helped them fall asleep faster.

Can Melatonin Help My Child Sleep?

Yes, this research suggests it can! The study looked at children and teens with ASD who had trouble sleeping. They found that a special type of melatonin, called prolonged-release melatonin minitablets (PedPRM), significantly improved sleep. Kids taking the melatonin slept almost an hour longer each night, and fell asleep about 40 minutes faster.

What The Research Found

More Sleep: Kids taking PedPRM slept an average of 57.5 minutes longer each night compared to those taking a placebo (a sugar pill).

Faster to Sleep: They also fell asleep about 40 minutes faster.

Better Overall Sleep: A larger percentage of kids taking melatonin showed significant improvements in their sleep compared to those taking the placebo.

Safe to Use: The melatonin was generally safe, with the most common side effect being feeling sleepy.

Study Details

Who was studied: 125 children and teenagers (ages 2-17.5) with autism spectrum disorder (ASD) or a related condition.

How long: The study lasted for 13 weeks (about 3 months).

What they took: Some kids took PedPRM (2mg, increased to 5mg if needed), and others took a placebo. The melatonin came in tiny tablets that were easy to swallow.

What This Means For You

Talk to your doctor: If your child with ASD has trouble sleeping, talk to their doctor about PedPRM. It could be a helpful option.

Consider the form: The tiny tablet form is designed to be easy for kids to take, which is a big plus.

Combine with other strategies: Melatonin may work best when combined with other sleep-promoting strategies, like a consistent bedtime routine.

Study Limitations

Short-term study: The study only lasted 3 months, so we don't know the long-term effects.

Focus on ASD: The study mainly focused on kids with ASD, so the results might not be the same for other conditions.

Relied on parent reports: The study relied on parents to track their child's sleep, which can be subjective.

Dosage: The study used a fixed dose escalation, which may not be optimal for all children.

Key Findings

The study demonstrated that prolonged-release melatonin minitablets (PedPRM) significantly improved sleep duration and latency in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders. Compared to placebo, PedPRM increased total sleep time (TST) by 57.5 minutes vs. 9.14 minutes (adjusted mean difference: -32.43 minutes; p=0.034) and reduced sleep latency (SL) by 39.6 minutes vs. 12.5 minutes (adjusted mean difference: -25.30 minutes; p=0.011). Clinically meaningful responses (improvements in TST and/or SL) occurred in 68.9% of PedPRM recipients vs. 39.3% with placebo (p=0.001; NNT=3.38). The formulation was well-tolerated, with somnolence as the primary adverse event.

Study Design

This was a double-blind, randomized, placebo-controlled clinical trial (RCT) involving 125 participants aged 2–17.5 years (96.8% ASD, 3.2% Smith-Magenis syndrome). After behavioral interventions failed, participants were randomized to PedPRM (2 mg escalated to 5 mg) or placebo for 13 weeks. Sleep outcomes were measured via caregiver-reported Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI).

Dosage & Administration

Participants received 2 mg of prolonged-release melatonin minitablets (PedPRM) once daily at bedtime, escalating to 5 mg after 1 week if needed. The formulation was designed for pediatric use, dissolving quickly without water, addressing swallowing difficulties common in the target population.

Results & Efficacy

Total Sleep Time (TST): PedPRM increased nighttime sleep by 57.5 minutes (adjusted mean difference vs. placebo: -32.43 minutes; p=0.034).
Sleep Latency (SL): SL decreased by 39.6 minutes with PedPRM vs. 12.5 minutes with placebo (adjusted mean difference: -25.30 minutes; p=0.011).
Clinical Response: 68.9% of PedPRM users achieved meaningful improvements vs. 39.3% with placebo (p=0.001; NNT=3.38).
Safety: PedPRM was generally safe; somnolence occurred more frequently (not quantified) but no severe adverse events were reported.

Limitations

Short Duration: The 13-week trial period limits conclusions about long-term efficacy and safety.
Population Specificity: Results primarily apply to ASD patients (96.8% of participants), with minimal data on other neurogenetic disorders (e.g., SMS).
Subjective Measures: Reliance on caregiver diaries introduces potential bias; objective measures (e.g., actigraphy) were not included.
Dose Escalation: The fixed-dose escalation (2 mg → 5 mg) may not account for individual variability in response.

Clinical Relevance

PedPRM offers a viable solution for insomnia in children with ASD and comorbidities like ADHD, particularly those struggling with conventional melatonin formulations. The 32-minute net gain in TST and 25-minute reduction in SL highlight its potential to address core sleep challenges. With a high acceptability rate (89% adherence), the minitablet format is practical for pediatric populations with swallowing difficulties. However, clinicians should monitor for somnolence and consider the lack of long-term data. The number-needed-to-treat (3.38) underscores its effectiveness relative to placebo, supporting its use as an adjunct to behavioral interventions. Future studies should evaluate extended safety, broader neurogenetic populations, and objective sleep metrics.

Source: PubMed | Trial Registration: NCT01906866