Management of sleep onset insomnia and melatonin use in typically developing children

Pediatric insomnia is a common disorder that impacts children and adolescents’ emotional, behavioural, and cognitive functioning, as well as parents’ sleep and daytime functioning, often leading to frequent consultations with paediatricians.  Waking overnight is the most common sleep behaviour during infancy and early childhood, reflecting normative patterns of child sleep consolidation.

After the age of 4 years, the main complaint is the difficulty sleeping independently namely sleep onset insomnia. These situations might be difficult to manage since most paediatricians and nurse practitioners are not trained in behavioural sleep problems and there is no consensus in Europe on the management of sleep onset insomnia and the use of melatonin in typically developing children. To bridge this gap a group of European experts has compiled a set of recommendations for the management of sleep onset insomnia, developing a step-by-step approach to support primary care paediatricians in their clinical practice. 

When sleep onset insomnia is present in otherwise healthy children, the management should follow a stepwise approach. Practical sleep hygiene indications and adaptive bedtime routine, followed by behavioural therapies, must be the first step. Cognitive behavioural therapy for insomnia (CBT-I) is the first-line treatment for adults, and existing studies show promising effects also for children and adolescents, at least in the short term. When these measures are not effective, low-dose melatonin, administered 30–60 min before bedtime, might be helpful in children over 2 years old. It is suggested to start with a minimum dose of 0.5 mg; if no effect is obtained after 1 week, the dose can be increased by titration to 1 mg or more if necessary, up to a maximum of 5 mg depending on age. Consider a dosage of 0.5 to 1 mg in infants 2 to 3 years of age; 1-2 mg in preschool children, up to 3 mg in school-age children, and up to 5 mg in adolescents. 

Parents should be informed regarding potential adverse events of melatonin use and lack of long-term safety data and advised to consult with a healthcare professional before using melatonin in children and not use it for longer than 14 days without doctor’s recommendation. Melatonin use should always be monitored by paediatricians to evaluate the efficacy as well as the presence of adverse effects. It is suggested to use melatonin for 3–4 weeks to stabilize sleep timing and duration, along with continuous sleep hygiene and behavioural corrections; then consider suspending it. In rare cases when these techniques do not help, referral to a sleep specialist may be considered.