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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics, Inc. at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebo-controlled trials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily. Information provided below is based on the pooled 12-week placebo-controlled studies in patients with narcolepsy or OSA. Most Common Adverse Reactions The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported more frequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populations were headache, nausea, decreased appetite, anxiety, and insomnia. Table 1 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently in SUNOSI-treated patients than in placebo-treated patients in the narcolepsy population. Table 1: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy (75 mg and 150 mg) * “Insomnia” includes insomnia, initial insomnia, middle insomnia, and terminal insomnia. “Anxiety” includes anxiety, nervousness, and panic attack. “Headache” includes headache, tension headache, and head discomfort. “Nausea” includes nausea and vomiting. Narcolepsy System Organ Class Placebo N = 108 (%) SUNOSI N = 161 (%) Metabolism and Nutrition Disorders Decreased appetite 1 9 Psychiatric Disorders Insomnia* Anxiety* 4 1 5 6 Nervous System Disorders Headache* 7 16 Cardiac Disorders Palpitations 1 2 Gastrointestinal Disorders Nausea* Dry mouth Constipation 4 2 1 7 4 3 Table 2 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently in SUNOSI-treated patients than in placebo-treated patients in the OSA population. Table 2: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in OSA (37.5 mg, 75 mg, and 150 mg) * “Anxiety” includes anxiety, nervousness, and panic attack. “Nausea” includes nausea and vomiting. “Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominal discomfort. OSA System Organ Class Placebo N = 118 (%) SUNOSI N = 235 (%) Metabolism and Nutrition Disorders Decreased appetite 1 6 Psychiatric Disorders Anxiety* Irritability 1 0 4 3 Nervous System Disorders Dizziness 1 2 Cardiac Disorders Palpitations 0 3 Gastrointestinal Disorders Nausea* Diarrhea Abdominal pain* Dry mouth 6 1 2 2 8 4 3 3 General Disorders and Administration Site Conditions Feeling jittery Chest discomfort 0 0 3 2 Skin and Subcutaneous Tissue Disorders Hyperhidrosis 0 2 Other Adverse Reactions Observed During the Premarketing Evaluation of SUNOSI Other adverse reactions of < 2% incidence but greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, or 4) which were not considered to have clinically significant implications. Narcolepsy population: Psychiatric disorders : agitation, bruxism, irritability Respiratory, thoracic and mediastinal disorders : cough Skin and subcutaneous tissue disorders : hyperhidrosis General disorders and administration site conditions : feeling jittery, thirst, chest discomfort, chest pain Investigations : weight decreased OSA population: Psychiatric disorders : bruxism, restlessness Nervous system disorders : disturbance in attention, tremor Respiratory, thoracic and mediastinal disorders : cough, dyspnea Gastrointestinal disorders : constipation, vomiting Investigations : weight decreased Dose-Dependent Adverse Reactions In the 12-week placebo-controlled clinical trials that compared doses of 37.5 mg, 75 mg, and 150 mg daily of SUNOSI to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, anxiety, diarrhea, and dry mouth ( Table 3 ). Table 3: Dose-Dependent Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy and OSA * In OSA only. ** “Headache” includes headache, tension headache, and head discomfort. “Nausea” includes nausea and vomiting. Placebo N = 226 (%) SUNOSI 37.5 mg N = 58* (%) SUNOSI 75 mg N = 120 (%) SUNOSI 150 mg N = 218 (%) Headache** 8 7 9 13 Nausea** 5 7 5 9 Decreased appetite 1 2 7 8 Anxiety 1 2 3 7 Dry mouth 2 2 3 4 Diarrhea 2 2 4 5 Adverse Reactions Resulting in Discontinuation of Treatment In the 12-week placebo-controlled clinical trials, 11 of the 396 patients (3%) who received SUNOSI discontinued because of an adverse reaction compared to 1 of the 226 patients (< 1%) who received placebo. The adverse reactions resulting in discontinuation that occurred in more than one SUNOSI-treated patient and at a higher rate than placebo were: anxiety (2/396; < 1%), palpitations (2/396; < 1%), and restlessness (2/396; < 1%). Increases in Blood Pressure and Heart Rate SUNOSI’s effects on blood pressure and heart rate are summarized below. Table 4 shows maximum mean changes in blood pressure and heart rate recorded at sessions where the Maintenance of Wakefulness Test (MWT) was administered [see Clinical Studies ( 14 )] . Table 5 summarizes 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory heart rate monitoring performed in the outpatient setting. Table 4: Maximal Mean Changes in Blood Pressure and Heart Rate Assessed at MWT Sessions from Baseline through Week 12: Mean (95% CI)* SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate * For study weeks 1, 4, and 12, SBP, DBP, and HR were assessed pre-dose and every 1-2 hours for 10 hours after test drug administration. For all time points at all visits, the mean change from baseline was calculated, by indication and dose, for all patients with a valid assessment. The table shows, by indication and dose, the mean changes from baseline for the week and time point with the maximal change in SBP, DBP, and HR. ** The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. Placebo SUNOSI 37.5 mg SUNOSI 75 mg SUNOSI 150 mg SUNOSI 300 mg ** Narcolepsy STUDY 1 n 52 - 51 49 53 SBP 3.5 (0.7, 6.4) 3.1 (0.1, 6.0) 4.9 (1.7, 8.2) 6.8 (3.2, 10.3) n 23 - 47 49 53 DBP 1.8 (-1.8, 5.5) 2.2 (0.2, 4.1) 4.2 (2.0, 6.5) 4.2 (1.5, 6.9) n 48 - 26 49 53 HR 2.3 (-0.1, 4.7) 3.7 (0.4, 6.9) 4.9 (2.3, 7.6) 6.5 (3.9, 9.0) OSA STUDY 2 n 35 17 54 103 35 SBP 1.7 (-1.4, 4.9) 4.6 (-1.1, 10.2) 3.8 (1.2, 6.4) 2.4 (0.4, 4.4) 4.5 (1.1, 7.9) n 99 17 17 107 91 DBP 1.4 (-0.1, 2.9) 1.9 (-2.3, 6.0) 3.2 (-0.9, 7.3) 1.8 (0.4, 3.2) 3.3 (1.8, 4.8) n 106 17 51 102 91 HR 1.7 (0.1, 3.3) 1.9 (-1.9, 5.7) 3.3 (0.6, 6.0) 2.9 (1.4, 4.4) 4.5 (3.0, 6.0) Table 5: Blood Pressure and Heart Rate by 24-hour Ambulatory Monitoring: Mean Change (95% CI) from Baseline at Week 8 SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate * Number of patients who had at least 50% valid ABPM readings. ** The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. Placebo SUNOSI 37.5 mg SUNOSI 75 mg SUNOSI 150 mg SUNOSI 300 mg ** Narcolepsy STUDY 1 n* 46 44 44 40 SBP -0.4 (-3.1, 2.4) - 1.6 (-0.4, 3.5) -0.5 (-2.1, 1.1) 2.4 (0.5, 4.3) DBP -0.2 (-1.9, 1.6) - 1.0 (-0.4, 2.5) 0.8 (-0.4, 2.0) 3.0 (1.4, 4.5) HR 0.0 (-1.9, 2.0) - 0.2 (-2.1, 2.4) 1.0 (-1.2, 3.2) 4.8 (2.3, 7.2) OSA STUDY 2 n* 92 43 49 96 84 SBP -0.2 (-1.8, 1.4) 1.8 (-1.1, 4.6) 2.6 (0.02, 5.3) -0.2 (-2.0, 1.6) 2.8 (-0.1, 5.8) DBP 0.2 (-0.9, 1.3) 1.4 (-0.4, 3.2) 1.5 (-0.04, 3.1) -0.1 (-1.1, 1.0) 2.4 (0.5, 4.4) HR -0.4 (-1.7, 0.9) 0.4 (-1.4, 2.2) 1.0 (-0.9, 2.81) 1.7 (0.5, 2.9) 1.6 (0.3, 2.9) 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of SUNOSI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Immune system disorders : Hypersensitivity (rash erythematous, rash [unspecified], and urticaria).