In 2011, the European Medicines Agency (EMA) recommended limiting the marketing authorisation for modafinil to the treatment of adults with excessive sleepiness associated with narcolepsy. Due to the possible risks and side effects, modafinil has since not been approved for other indications, for the treatment of children and adolescents, and during pregnancy and breastfeeding.
Side effects may include: Headache, nervousness, palpitations, abdominal pain and/or dry mouth. In addition, modafinil may interfere with the effectiveness of oral contraceptives! Therefore, the use of additional contraceptive methods is recommended while taking it. Further risks are cardiovascular diseases such as cardiac arrhythmias, diseases of the heart muscles, cardiac insufficiency and/or high blood pressure. Furthermore, the consumption of modafinil can affect the psyche and cause hostility, aggression, psychosis/psychotic disorders, depression, insomnia, up to delusions and/or anxiety.
Symptoms of overdose with modafinil alone or in combination with other medicines: Insomnia; central nervous symptoms (restlessness, disorientation, confusion, agitation, hallucinations); nausea, diarrhoea; palpitations, high blood pressure, chest pain, slow heartbeat.
Since modafinil affects the dopamine balance in the brain, among other things, there is an increased potential for physical dependence. If modafinil is consumed for the purpose of performance enhancement and promotion of alertness with the intention of being able to achieve high performance with little sleep, there is also a risk of psychological dependence.
The long-term effect of modafinil when taken regularly and over a longer period of time has been little studied so far. If taken over a longer period of time, regular monitoring by a medical specialist is therefore recommended.