SUNOSI

/ Neopharm Ltd, Israel

Blood pressure and heart rate should be assessed before initiating treatment with solriamfetol and should be monitored periodically during treatment, especially after increasing the dose. Pre-existing hypertension should be controlled before initiating treatment with solriamfetol and caution should be exercised in treating patients at higher risk of major adverse cardiac events (MACE), particularly patients with pre-existing hypertension, patients with known cardiovascular or cerebrovascular disease and elderly patients.
Narcolepsy
The recommended starting dose is 75 mg once daily, upon awakening. If clinically indicated in patients with more severe levels of sleepiness, a starting dose of 150 mg may be considered. Depending on clinical response, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days, with a recommended maximum daily dose of 150 mg once daily.
OSA
The recommended starting dose is 37.5 mg once daily, upon awakening. Depending on clinical response, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 days, with a recommended maximum daily dose of 150 mg once daily.
Taking Sunosi less than 9 hours before bedtime should be avoided as it may affect night time sleep.
Special populations
Elderly (> 65 years)
Limited data are available in elderly patients. Consideration should be given to the use of lower doses and close monitoring in this population (see section 4.4). Solriamfetol is predominantly eliminated by the kidney and since elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on creatinine clearance in these patients.
Renal impairment
Moderate renal impairment (creatinine clearance of 30-59 mL/min): The recommended starting dose is 37.5 mg once daily. Dose may be increased to a maximum of 75 mg once daily after 5 days.
Severe renal impairment (creatinine clearance of 15-29 mL/min): The recommended dose is 37.5 mg once daily.
End stage renal disease (creatinine clearance <15 mL/min): Solriamfetol is not recommended for use in patients with end stage renal disease.

* Indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy).
* 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).

* Hypersensitivity to the active substance or to any of the excipients
* 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.

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.
Use in patients with unstable cardiovascular disease, serious heart arrhythmias and other serious heart problems is contraindicated.
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
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
Women of childbearing potential or their male partners must use effective method of contraception while taking solriamfetol.

Very common: Headache
Common: Decreased appetite, Anxiety, Insomnia , Irritability, Bruxism, Dizziness, Palpitations, Cough, Nausea, Diarrhoea, Dry mouth, Abdominal pain, Constipation, Vomiting, Hyperhidrosis, Feeling jittery, Chest discomfort, Blood pressure increased.
See prescribing information for full details.

No interaction studies have been performed.
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.
Concomitant use of medicinal products that increase blood pressure and heart rate should be used with caution.
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.

Pregnancy: There are no or limited amount of data from the use of solriamfetol in pregnant women. Animal studies have shown reproductive toxicity. solriamfetol is not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation: Solriamfetol is excreted in human milk at approximately 4 % of the maternal dose on a weight-adjusted basis. 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 therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the women.
Infants exposed to solriamfetol should be monitored for signs of agitation, insomnia, and reduced weight gain.

There have been no reports of overdose of solriamfetol in the clinical studies.
In healthy volunteers, there was one adverse reaction of mild tardive dyskinesia and one adverse reaction of moderate akathisia that occurred at a supratherapeutic dose of 900 mg; symptoms resolved after treatment discontinuation.
There is no specific antidote. In the case of inadvertent overdose, symptomatic and supportive medical care should be provided and patients should be carefully monitored, as appropriate.

Store below 25°C.
Once opened, use within 120 days, store below 25°C.