Product Dossier
CIRCADIN
Product Dossier for CIRCADIN (melatonin, RAD Data). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: RAD Data
- Active ingredient: melatonin
- Therapeutic area: Psychiatry
- Related brand: VOQUILY
- Related brand: IMMELA
- Related brand: SomniCare
- Same area: REXULTI
- Same area: NICORETTE
What it is
CIRCADIN contains melatonin in strengths of 2 mg, 3 mg or 5 mg as capsules , and 1 mg/mL as an oral solution . Melatonin is a hormone and antioxidant . Melatonin secreted by the pineal gland is involved in the synchronisation of circadian rhythms to the diurnal light-dark cycle .
Approved indications
— Short-term treatment of jet lag in adults aged 18 and over . — Sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been insufficient .
Dosing overview
It is recommended that CIRCADIN is administered on an empty stomach and food is not consumed 1 hour before and 1 hour after intake . For jet lag, CIRCADIN should not be taken before 8pm or after 4am destination time .
Key safety warnings
Melatonin may cause daytime drowsiness, and CIRCADIN should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety . CIRCADIN is not recommended prior to driving and using machines until the effects are known . Melatonin may increase seizure frequency in patients experiencing seizures (such as epileptic patients), and patients suffering from seizures must be informed about this possibility before using melatonin . Melatonin may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects . There is no data concerning the use of melatonin in patients with autoimmune diseases, and therefore CIRCADIN is not recommended in patients with autoimmune diseases . Patients with hereditary fructose intolerance should not take this medicinal product (the oral solution contains sorbitol). Endogenous melatonin has been detected in human breast milk, thus exogenous melatonin is likely excreted into human milk, and breast-feeding is not recommended in women under treatment with melatonin .
Contraindications
Hypersensitivity to the active substance or to any of the excipients .
Regulatory history
CIRCADIN melatonin 2 mg prolonged release tablet was first listed on the ARTG on 25 November 2009 . An AusPAR was approved on 4 January 2011 for an extension of indications, allowing the recommended duration of treatment to be extended to up to 13 weeks for primary insomnia in patients aged 55 or over . A PBAC submission was deferred in December 2023 .