SomniCare

What it is

SomniCare is melatonin available in capsule strengths of 2 mg, 3 mg or 5 mg. An oral solution formulation containing 1 mg/mL of melatonin is also available. 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 SomniCare is administered on an empty stomach and food is not consumed 1 hour before and 1 hour after intake.

Key safety warnings

Melatonin may cause daytime drowsiness, and SomniCare should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. SomniCare 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 SomniCare. 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 SomniCare 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, and the use of melatonin in combination with these drugs is not recommended. Caution should be exercised in patients on fluvoxamine, which increases melatonin levels significantly by inhibiting its metabolism, and the combination should be avoided.

Contraindications

SomniCare is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Patients with hereditary fructose intolerance should not take the oral solution formulation. SomniCare is not recommended for patients with hepatic impairment due to markedly elevated daytime melatonin concentrations resulting from reduced clearance. SomniCare is not recommended for patients with renal impairment due to limited available data.

PBS listing

In December 2023, PBAC recommended listing for SomniCare for the treatment of insomnia in patients between the ages of 2 to 18 with Smith-Magenis syndrome.

Regulatory history

SomniCare melatonin prolonged-release tablets was first listed on the ARTG on 20 September 2023 under licence category RE. PBAC considered SomniCare for insomnia in children and adolescents with autism spectrum disorder and Smith-Magenis syndrome, with initial recommendations of not recommended in March 2021 and a deferred decision in July 2021 for Smith-Magenis syndrome alone. In December 2023, PBAC recommended listing for insomnia in patients aged 2 to 18 with Smith-Magenis syndrome.