IMMELA

What it is

IMMELA capsules contain 2 mg, 3 mg or 5 mg of melatonin. IMMELA oral solution contains 1 mg/mL of melatonin. 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 IMMELA is administered on an empty stomach and food is not consumed 1 h before and 1 h after intake of IMMELA.

Key safety warnings

Melatonin may cause daytime drowsiness. Therefore, IMMELA should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. As melatonin may cause drowsiness, IMMELA is not recommended prior to driving and using machines until the effects are known. Melatonin may increase seizure frequency in patients experiencing seizures (e.g. epileptic patients). 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. Therefore, IMMELA is not recommended in patients with autoimmune diseases. Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. The use of melatonin in combination with these drugs is not recommended. Melatonin may increase the anticoagulation activity of warfarin. The combination of warfarin or other vitamin K antagonists with melatonin may require dose adjustment of the anticoagulant drugs and should be avoided.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the product information.

Key safety considerations

Limited data indicates that daytime endogenous blood melatonin concentration is markedly elevated in patients with hepatic impairment due to reduced clearance. Therefore, IMMELA is not recommended for patients with hepatic impairment. Limited data is available for the use of melatonin in patient with renal impairment. Therefore, IMMELA is not recommended for patients with renal impairment. In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended. Breast-feeding is not recommended in women under treatment with melatonin.

Regulatory history

IMMELA melatonin was first registered on the ARTG on 2023-10-27, with four variants listed: 2 mg capsule, 3 mg capsule, 5 mg capsule, and 1 mg/mL oral solution. The AusPAR approval date was 2023-10-03.