SLENYTO

What it is

SLENYTO is a prolonged release tablet containing melatonin in strengths of 1 mg and 5 mg. The active ingredient is melatonin not of plant or animal origin. Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. The activity of melatonin at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties via their distinct actions on the circadian clock.

Approved indications

— Treatment of insomnia in children and adolescents aged 2–18 with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

Dosing overview

The recommended starting daily dose is 2 mg of SLENYTO. If an inadequate response has been observed, the daily dose should be increased to 5 mg, with a maximal dose of 10 mg. SLENYTO should be taken once daily, 0.5–1 hour before bedtime and with or after food. Tablets should be swallowed whole and should not be broken, crushed or chewed because it will lose the prolonged release properties.

Key safety warnings

Melatonin may cause drowsiness. Therefore the medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. Patients should avoid engaging in hazardous activities (such as driving or operating machinery) after taking melatonin. No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases. Therefore SLENYTO is not recommended for use in patients with autoimmune diseases. Caution should be exercised in patients on fluvoxamine, which increases melatonin levels by inhibiting its metabolism by hepatic cytochrome P450 isozymes. The combination should be avoided. Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics. Combination with benzodiazepines and non-benzodiazepine hypnotics should be avoided. The most frequently reported adverse reactions with SLENYTO in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100–1:10 children.

Contraindications

SLENYTO prolonged release tablets are contraindicated in patients with a known hypersensitivity to any ingredient of the product. The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.

PBS listing

SLENYTO 1 mg modified release tablets are listed on the PBS with authority required restriction at an ex-manufacturer price of A$55.00. SLENYTO 5 mg modified release tablets are listed on the PBS with authority required restriction at an ex-manufacturer price of A$130.00.

Regulatory history

Slenyto was approved by the TGA on 20 May 2020 for the treatment of insomnia in children and adolescents aged 2–18 with Autism Spectrum Disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. ARTG registrations were granted on 22 May 2020 for both the 1 mg and 5 mg prolonged release tablet formulations.