First approval of melatonin in UK, as MHRA clears it for insomnia in ADHD children

Melatonin, a natural hormone that is produced by the pineal gland and used by many long-haul airline travellers to mitigate their jet-lag symptoms, has gained its first approval in the UK, but as a treatment for sleep onset insomnia in children and adolescents aged six-17 years with attention-deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been inadequate.

The Medicines and Healthcare products Regulatory Agency granted the approval for Clinigen Group subsidiary Colonis’ Melatonin 1mg/ml Oral Solution.

Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia.