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Human medicines European public assessment report (EPAR): Sunosi, solriamfetol, Narcolepsy;Sleep Apnea, Obstructive, Date of authorisation: 16/01/2020, Revision: 8, Status: Authorised

The most common side effect with Sunosi, which may affect more than 1 in 10 people, is headache. Common side effects, which may affect up to 1 in 10 people, are decreased appetite, anxiety, insomnia (difficulty sleeping), irritability, bruxism (teeth grinding), dizziness, palpitations (a forceful heartbeat that may be rapid or irregular), cough, nausea (feeling sick), diarrhoea, dry mouth, abdominal pain (belly ache), constipation, vomiting, hyperhidrosis (excessive sweating), feeling jittery, chest discomfort and increased blood pressure. 

Sunosi must not be used in patients who have uncontrolled hypertension (high blood pressure) or serious heart problems including heart attack in the past year, unstable angina pectoris (chest pain caused by interruptions in blood supply to the heart, that may occur at rest or without an obvious trigger) and serious cardiac arrhythmias (abnormal or irregular heartbeat). It must not be taken at the same time as certain medicines called monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping these medicines.

For the full list of side effects and restrictions with Sunosi, see the package leaflet.

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