Use of marketed melatonin products

The following melatonin medicines have Marketing Authorisation (MA) and are marketed in Norway: 

Melatonin Unimedic

Form: Oral solution 1 mg/ml 

Indications: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient. Short-term treatment of jet lag in adults. 

Melatonin AGB 

Form: Tablets (1 mg, 2 mg, 3 mg, 4 mg, 5 mg)

Indications: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient. Short-term treatment of jet lag in adults. 

Melatonin Orifarm 

Form: Tablets (2 mg, 3 mg)

Indications: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient. Short-term treatment of jet lag in adults. 

Melatonin Orion 

Form: Tablets (3 mg, 5 mg)

Indications: Short-term treatment of jet lag. 

Circadin Neurim, Circadin Orifarm, Mecastrin, Melatonin Teva 

Form: Sustained-release tablets 2 mg 

Indications: Short-term treatment of primary insomnia in patients aged ≥55 years. 

Slenyto 

Form: Sustained-release tablets (1 mg, 5 mg) 

Indications: Insomnia in children aged 2-18 years with autism spectrum disorder (ASD) and Smith-Magenis syndrome. 

Pre-approved Reimbursement for Melatonin Treatment 

Melatonin AGB (tablets 1, 2, 3, 4, and 5 mg), Melatonin Orifarm (tablets 3 mg), and Melatonin Unimedic (oral solution 1 mg/ml) have pre-approved reimbursement for treating insomnia in children with ADHD (aged 6-17 years) where sleep hygiene measures have been insufficient. 

Patients must have: 

• reduced daytime function with either increased sleepiness/fatigue, mood swings, impaired cognitive function, impaired social function, increased accident risk, physical discomfort, or concern about sleep.
• at least three poor nights per week or a circadian rhythm that cannot be normalized. 

Slenyto (sustained-release tablets 1 mg and 5 mg) has pre-approved reimbursement for treating insomnia in children and adolescents aged 2-18 years with autism spectrum disorders (ASD) and/or Smith-Magenis syndrome (SMS). 

Individual Reimbursement for Melatonin Treatment 

The Norwegian Health Economics Administration (HELFO) provides individual reimbursement for melatonin products for various sleep disorders. If a patient has an individual reimbursement decision from HELFO for unregistered tablets or capsules with 3 mg melatonin, this decision will also apply to Melatonin AGB and Melatonin Orifarm. The same applies to patients with decisions for unregistered oral solutions or drops with 1 mg/ml melatonin. 

Dietary Supplements with Melatonin 

The Norwegian Medical Products Agency (NOMA) has determined that products with a daily dose of up to 1 mg melatonin do not always need to be classified as medicinal products. This allows melatonin in low doses to be sold as dietary supplements. The regulations for dietary supplements are handled by the Norwegian Food Safety Authority. Currently, melatonin products with up to 1 mg daily dose are sold in stores and are also allowed for private import.