Introduction

The drug lisdexamfetamine dimesylate (commonly shortened to lisdexamfetamine, trade name EU: Elvanse, U.S.: Vyvanse) has been approved in Germany since March 2013 for the treatment of attention deficit hyperactivity disorder (ADHD) in children from the age of 6 years. It is considered as a treatment option if previous treatment with the drug methylphenidate was unsuccessful.

Its approval was expanded in February 2019: Lisdexamfetamine (trade name: Elvanse Adult) can now also be used in adults who have had ADHD symptoms since childhood.

At home, at school and with friends, children with ADHD have noticeable trouble concentrating, are fidgety and in many cases very impatient and impulsive. It is often difficult to determine whether a child has ADHD. One of the requirements is that the child must have had noticeably unusual behavior for several months.

In many cases the symptoms improve with age, but they can sometimes carry on into adulthood. The symptoms of ADHD are often different in adults, though. Hyperactivity is less of a problem, and inattentiveness becomes the most noticeable symptom. Although ADHD is less apparent in adults than it is in children, adults with ADHD often struggle to organize things in everyday life or to concentrate for longer periods of time. They are also usually very impulsive, which can cause problems in their social life.

Treatment of ADHD in children, teenagers and adults involves a combination of psychological, educational and social interventions. Lisdexamfetamine is meant to be used in addition to these interventions with the aim of relieving the symptoms of ADHD in children and adults.

Application

The drug is available in capsule form at various doses up to 70 mg. The starting dose is usually 30 mg once a day. If necessary, the dose can be increased at weekly intervals, but it shouldn't exceed 70 mg per day. Lisdexamfetamine should not be taken in the afternoon because it can cause sleep problems.

The treatment must be managed by an expert in behavioral disorders. If the symptoms don’t improve within a month even after increasing the dose, the treatment should be stopped.

Other treatments

The drug atomoxetine is one option for children over the age of 6 whose symptoms don't improve enough with the drug methylphenidate.

For adults who haven't had any treatment with medication yet, atomoxetine and methylphenidate can be considered. Adults who have already had treatment are given individual treatment, taking into account the interventions that have been tried before. In most cases, atomoxetine or methylphenidate are used here as well.

Assessment

In 2013, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of lisdexamfetamine for children aged 6 and over. The manufacturer didn't provide any suitable data with which to answer this question.

In 2019, IQWiG assessed the advantages and disadvantages of lisdexamfetamine compared with the standard treatments for ADHD in adults. Again, the manufacturer didn’t provide any suitable studies for this comparison.

It remains unclear whether lisdexamfetamine has any advantages or disadvantages for children and adults.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of lisdexamfetamine (Elvanse / Elvanse Adult / Vyvanse) for children and adults.