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MHRA approves melatonin solution for children and adolescents with ADHD

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Colonis’ Melatonin 1mg/ml Oral Solution as a treatment to improve sleep in children and adolescents with attention-deficit hyperactivity disorder (ADHD), the manufacturer has announced.

The prescription-only medicine is suitable for those aged 6-17 for whom other sleep hygiene measures have been inadequate, Colonis said in a release yesterday (October 3).

The recommended dose starts from 1-2 mg, to be taken 30-60 minutes before bedtime.

Children with ADHD are more likely to suffer from sleep onset insomnia, which is characterised by difficulty in falling asleep, the manufacturer said.

Colonis director of medical affairs Henno Welgemoed welcomed the MHRA’s approval.

“This approval provides a valuable treatment option for children and adolescents suffering with ADHD and sleep onset insomnia,” he said.

Pharmacists can order Colonis’ Melatonin 1mg/ml Oral Solution from all the mainline wholesalers.

The product is listed in October’s drug tariff at £155.57 for a 150ml bottle.

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