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Modified-release melatonin is an unsubsidised medicine that is approved for the treatment of insomnia in adults aged over 55 years; other formulations of melatonin
are unapproved. Melatonin is not currently approved for younger patients as the trials that showed modified-release melatonin was moderately effective at treating insomnia
only included people aged over 55 years. Prescribers are reminded that non-pharmacological interventions, e.g. improving sleep hygiene, are the first-line treatment for
insomnia. Patients taking modified-release melatonin for insomnia should do so one to two hours before bedtime, for up to 13 weeks. There is some evidence that “off-label”
use of melatonin may improve sleep quality in shift workers or reduce the severity of jetlag. Melatonin may also be used in specialist situations, such as in people with
vision impairments and adolescents or children with neurodevelopmental disorders and sleep disturbances. The effects of long-term melatonin use are unknown due to a lack
of studies therefore this should be considered with caution.
For further information, see: “Melatonin: is it worth losing any sleep over”, BPJ 69 (Aug, 2015).