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Sleep disturbances are common in children with developmental disorders. In a multicenter, randomized, placebo-controlled trial, investigators examined the effectiveness of melatonin for treating severe sleep disorders (>1 hour sleep latency, <6 hours of sleep, or both for 3 of 5 nights for ≥5 months) in 146 children with neurodevelopmental disorders (age range, 3–15 years) in the U.K. Immediate-release melatonin was given 45 minutes before bedtime for 12 weeks starting at a dose of 0.5 mg and increased to 12 mg based on sleep response.
After 12 weeks, melatonin significantly increased total sleep time by 22 minutes on the basis of sleep diaries (the primary outcome) compared with placebo, and reduced sleep onset latency by 38 minutes. On the…