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Objectives <p>To assess the efficacy and safety of oral melatonin in treating sleep problems in children with cerebral palsy (CP).</p> Methods <p>A randomized, double-blind, placebo-controlled trial was conducted at a tertiary care government hospital in 120 children with CP (3 to 12 y) suffering from sleep problems and who failed to respond to non-pharmacological therapy (4 wk). Participants were randomized to receive oral melatonin (3&#xa0;mg escalated to 10&#xa0;mg)/ placebo for 12 wk. Sleep measures included the Sleep Disturbance Scale for Children (SDSC), and caregivers reported sleep and nap diaries (SND). Outcome measures included decreased sleep onset latency (SOL) and increased total sleep time (TST) calculated using sleep diaries at 4 and 12 wk.</p> Results <p>The mean (SD) total sleep time in the melatonin and placebo groups was 5.09 (0.76) vs. 4.90 (0.77) h [Mean difference (MD) 0.19; <i>P</i> = 0.17] at baseline; 5.66 (0.84) vs. 4.89 (0.83) h (MD 0.77; <i>P</i> &lt; 0.001) at 4 wk; 6.29 (0.78) vs. 4.98 (0.85) h (MD 1.31; <i>P</i> &lt; 0.001) at 12 wk, respectively. The mean (SD) sleep onset time in melatonin and placebo groups was 79.18 ± 17.89 vs. 76.78 <i>±</i> 13.60&#xa0;min (MD 2.4; <i>P</i> = 0.41) at baseline; 63.70 ± 16.63 vs. 72.89 <i>±</i> 15.38&#xa0;min (MD 9.19; <i>P</i> &lt; 0.003) at 4 wk; 43.20 <i>±</i> 15.57 vs. 70.92 <i>±</i> 14.95&#xa0;min (MD 27.72; <i>P</i> &lt; 0.001) at 12 wk, respectively. Melatonin was well tolerated with minimal side effects (<i>n</i> = 10).</p> Conclusions <p>Melatonin, at a dose range of 3–10&#xa0;mg once daily can significantly reduce SOL and improve TST in children with CP who have sleep problems with minimal adverse effects.</p>

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Oral Melatonin Supplementation for Sleep Disturbances in Children with Cerebral Palsy: A Randomized Double-Blind Controlled Trial

  • 期刊论文

  • 发表日期：

    2025年12月10日

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  • Gire Pooja K.,
  • Smita Mundada,
  • Janhavi Zambani,
  • Trupti Joshi,
  • Prabha Khaire,
  • Shilpa Pawar,
  • Madhavi Shelke

摘要

Objectives

To assess the efficacy and safety of oral melatonin in treating sleep problems in children with cerebral palsy (CP).

Methods

A randomized, double-blind, placebo-controlled trial was conducted at a tertiary care government hospital in 120 children with CP (3 to 12 y) suffering from sleep problems and who failed to respond to non-pharmacological therapy (4 wk). Participants were randomized to receive oral melatonin (3 mg escalated to 10 mg)/ placebo for 12 wk. Sleep measures included the Sleep Disturbance Scale for Children (SDSC), and caregivers reported sleep and nap diaries (SND). Outcome measures included decreased sleep onset latency (SOL) and increased total sleep time (TST) calculated using sleep diaries at 4 and 12 wk.

Results

The mean (SD) total sleep time in the melatonin and placebo groups was 5.09 (0.76) vs. 4.90 (0.77) h [Mean difference (MD) 0.19; P = 0.17] at baseline; 5.66 (0.84) vs. 4.89 (0.83) h (MD 0.77; P < 0.001) at 4 wk; 6.29 (0.78) vs. 4.98 (0.85) h (MD 1.31; P < 0.001) at 12 wk, respectively. The mean (SD) sleep onset time in melatonin and placebo groups was 79.18 ± 17.89 vs. 76.78 ± 13.60 min (MD 2.4; P = 0.41) at baseline; 63.70 ± 16.63 vs. 72.89 ± 15.38 min (MD 9.19; P < 0.003) at 4 wk; 43.20 ± 15.57 vs. 70.92 ± 14.95 min (MD 27.72; P < 0.001) at 12 wk, respectively. Melatonin was well tolerated with minimal side effects (n = 10).

Conclusions

Melatonin, at a dose range of 3–10 mg once daily can significantly reduce SOL and improve TST in children with CP who have sleep problems with minimal adverse effects.