MELAKSO

What it is

MELAKSO capsules contain 2 mg, 3 mg or 5 mg of melatonin. MELAKSO 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. Melatonin has a hypnotic and sedative effect and increases propensity for sleep.

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 MELAKSO is administered on an empty stomach and food is not consumed 1 h before and 1 h after intake of MELAKSO. The patient should be monitored at regular intervals (at least every 6 months) to check that MELAKSO is still the most appropriate treatment. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.

Key safety warnings

Melatonin may cause daytime drowsiness. Therefore, MELAKSO should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. 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, MELAKSO is not recommended in patients with autoimmune diseases. Limited data indicates that daytime endogenous blood melatonin concentration is markedly elevated in patients with hepatic impairment due to reduced clearance. Therefore, MELAKSO is not recommended for patients with hepatic impairment. Limited data is available for the use of melatonin in patients with renal impairment. Therefore, MELAKSO is not recommended for patients with renal impairment. Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. In a study of jet lag therapy the combination of melatonin and zolpidem resulted in a higher incidence of morning sleepiness, nausea, and confusion, increased impairment of attention, memory and coordination as well as reduced activity during the first hour after getting up, compared to zolpidem alone. The use of melatonin in combination with these drugs is not recommended. Caution should be exercised in patients on fluvoxamine, which increases melatonin levels (17-fold higher AUC and 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19. The combination should be avoided. 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. Patients with hereditary fructose intolerance should not take MELAKSO oral solution.

Regulatory history

Approval was granted on 2023-10-03. MELAKSO capsules and oral solution were first listed on the ARTG on 2023-10-27.