For Whom Is MELATONIN Licensed?

Suitable Patients for Melatonin

Melatonin products are available for the management of a number of sleep disorders. Please note, most melatonin products are licensed for some but not all sleep disorders.

Melatonin products are licensed for the following patients:

  • Insomnia in children aged 6-17 years with ADHD where sleep hygiene measures have been insufficient.
  • The short-term treatment of jet lag in adults.1
  • Monotherapy for short-term treatment of primary insomnia characterised by poor quality sleep in patients aged 55 years or over3
  • Insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.4
  • Delayed sleep wake phase disorder (DSWPD) in children and adolescents aged 6-17 years and adults up to 25 years of age, where sleep hygiene measures have been insufficient. 5
  • The short-term treatment of jet lag in adults.
  • Those with renal impairment
  • Those with hepatic impairment (Adaflex is not recommended in patients with moderate or severe hepatic impairment)
  • Children with ADHD under 6 years of age should not take ADAFLEX
  • Those with epilepsy
  • Melatonin should not be taken by patients with autoimmune diseases.
  • Those with hypersensitivity to the active substance or to any of the excipients.
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UK-AGB-ADA-0020 | Date of preparation: January 2024

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