Sunosi · 4.8 Undesirable effects · 1

HOS-098885 · has-adverse-reaction-information · PDF-Seite 5

5 Summary of the safety profile The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%). Tabulated list of adverse reactions The frequency of adverse reactions is defined using the following MedDRA frequency convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). System Organ Class Adverse reactions Frequency Metabolism and nutrition disorders Decreased appetite Common Psychiatric disorders Anxiety Common Insomnia Common Irritability Common Bruxism Common Agitation Uncommon Restlessness Uncommon Nervous system disorders Headache Very common Dizziness Common Disturbance in attention Uncommon Tremor Uncommon Cardiac disorders Palpitations Common Tachycardia Uncommon Vascular Disorders Hypertension Uncommon Respiratory, thoracic and mediastinal disorders Cough Common Dyspnoea Uncommon Gastrointestinal disorders Nausea Common Diarrhoea Common Dry mouth Common Abdominal pain Common Constipation Common

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HOS-098881 · has-contraindication-information · PDF-Seite 4

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  Myocardial infarction within the past year, unstable angina pectoris, uncontrolled hypertension, serious cardiac arrhythmias and other serious heart problems.  Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment has been discontinued (see section 4.5).

HOS-098880 · has-indication-information · PDF-Seite 2

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

HOS-098883 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed (see section 5.2). Solriamfetol must not be administered concomitantly with MAOIs or within 14 days after MAOI treatment has been discontinued because it may increase the risk of a hypertensive reaction (see section 4.3). Concomitant use of medicinal products that increase blood pressure and heart rate should be used with caution (see section 4.4). Medicinal products that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with solriamfetol. Concomitant use of such medicinal products should be used with caution.

HOS-098884 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of solriamfetol in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Sunosi is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding Solriamfetol is excreted in human milk at approximately 4 % of the maternal dose on a weight- adjusted basis (see section 5.2). The effect of solriamfetol on newborns/infants or its impacts on milk production are unknown. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Sunosi therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the women. Fertility The effects of solriamfetol in humans are unknown. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

HOS-098882 · has-warning-information · PDF-Seite 4

Psychiatric symptoms Solriamfetol has not been evaluated in patients with a history of or concurrent psychosis or bipolar disorders. Caution should be exercised when treating these patients due to psychiatric adverse reactions that could exacerbate symptoms (e.g. manic episodes) of pre-existing psychiatric disorders. Patients treated with solriamfetol should be carefully monitored for adverse reactions such as anxiety, insomnia and irritability. These adverse reactions were commonly observed during treatment initiation, but tended to resolve with continued treatment. If these symptoms persist or worsen, dose reduction or discontinuation should be considered. Blood pressure and heart rate Analyses of data from clinical trials showed that treatment with solriamfetol increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose dependent fashion. Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular event (MACE), including stroke, heart attack and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia and high body mass index (BMI). Use in patients with unstable cardiovascular disease, serious heart arrhythmias and other serious heart problems is contraindicated (see section 4.3). Patients with moderate or severe renal impairment may be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of solriamfetol. Abuse Sunosi was assessed in a human abuse potential study and demonstrated low abuse potential. Results from this clinical study demonstrated that solriamfetol produced Drug Liking scores higher than placebo, but generally similar or lower than phentermine (a weak stimulant). Caution should be exercised when treating patients with a history of stimulant (e.g. methylphenidate, amphetamine) or alcohol abuse, and these patients should be monitored for signs of misuse or abuse of solriamfetol. Angle closure glaucoma Mydriasis may occur in patients taking solriamfetol. Caution is advised in patients with increased ocular pressure or at risk of angle closure glaucoma. Women of childbearing potential or their partners 4 Wom

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