Introduction

Melatonin (trade name: Slenyto) has been approved in Germany since September 2018 for the treatment of insomnia in teenagers and children over the age of two with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome (SMS). The medication is an option if non-drug interventions have not improved the quality of sleep enough.

Autism spectrum disorder

The autism spectrum includes several types of autism in which abnormal behavior already starts in early childhood. Typical symptoms include problems or limitations in social situations, unusual, repetitive behaviors (such as uniform motions) or very distinct, special interests. Many children and teenagers with autism spectrum disorder have trouble falling asleep or sleeping through the night.

Smith-Magenis syndrome

Das Smith-Magenis syndrome (SMS) is a very rare congenital condition in which part of chromosome 17 is missing. It causes a variety of symptoms, such as diminished performance capability, psychological abnormalities, or deformities of the head, the face or the skeletal structure. Insomnia is common as well.

Insomnia

People who have insomnia don't get enough rest when they sleep and are unable to sleep long enough, so they feel tired and beat the next day. Melatonin is a hormone produced naturally by the body responsible for controlling sleep patterns. It is meant to increase sleep duration.

Application

Melatonin is taken once a day in tablet form 30 to 60 minutes before bedtime, together with or after a meal.

The dose starts at 2 mg. If necessary, it can be increased first to 5 mg and then to 10 mg. One tablet contains either 1 or 5 mg of melatonin.

Other treatments

Best supportive care (BSC) is one treatment option for children and teenagers with autism spectrum disorder or Smith-Magenis syndrome which causes insomnia. BSC includes several measures to improve sleep quality, such as making sure the bedroom is quiet, dark and at a comfortable temperature, only listening to quiet music and not using a phone or computer before going to bed.

It should be tailored to the patient’s individual needs and improve symptoms such as drowsiness as well as improve quality of life.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages or disadvantages of melatonin compared with the standard treatments for insomnia in children and teenagers with autism spectrum disorder and/or Smith-Magenis syndrome.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of melatonin (Slenyto).