Sunosi

Treatment should be initiated by a healthcare professional experienced in the treatment of narcolepsy or OSA. Sunosi is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained in these patients.

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 3 patients with pre-existing hypertension, patients with known cardiovascular or cerebrovascular disease and elderly patients.

The need for continued treatment with solriamfetol should be periodically assessed. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of solriamfetol or other appropriate medical intervention, discontinuation of solriamfetol should be considered.

5). Posology 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.

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.

Long-term use The need for continued treatment and the appropriate dose should be periodically assessed during extended treatment in patients prescribed solriamfetol. Special populations Elderly (> 65 years) Limited data are available in elderly patients.

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 Mild renal impairment (creatinine clearance of 60-89 mL/min):

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 Vomiting Common Skin and subcutaneous tissue disorders Hyperhidrosis Common General disorders and administration site conditions Feeling jittery Common Chest discomfort Common Chest pain Uncommon Thirst Uncommon Investigations Heart rate increased Uncommon Blood pressure increased Common Weight decreased Uncommon Description of selected adverse reactions Treatment initiation The majority of the most frequently reported adverse reactions occurred within the first 2 weeks of initiating treatment and resolved for the majority of patients with a median duration of less than 2 weeks.

3). 5 mg, 75 mg and 150 mg/day of solriamfetol to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, anxiety, diarrhoea and dry mouth. The dose relationships were generally similar in OSA and narcolepsy patients.

Certain events such as anxiety, insomnia, irritability, and agitation were commonly observed during treatment initiation, but tended to resolve with continued treatment. 4). Discontinuation of treatment In the 12-week placebo-controlled clinical trials, 11 of the 396 patients (3%) who received solriamfetol discontinued due to an adverse reaction compared to 1 of the 226 patients (<1%) who received placebo.

Psychiatric symptoms Solriamfetol has not been evaluated in patients with a history of or concurrent psychosis or bipolar disorders. 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). 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).

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.

1.  Myocardial infarction within the past year, unstable angina pectoris, uncontrolled hypertension, serious cardiac arrhythmias and other serious heart problems. 5).