Gastrointestinal Disorders
Nausea* 6 8
Diarrhea 1 4
Abdominal pain* 2 3
Dry mouth 2 3
General Disorders and
Administration Site Conditions
Feeling jittery 0 3
Chest discomfort 0 2
Skin and Subcutaneous Tissue
Disorders
Hyperhidrosis 0 2
*“Anxiety” includes anxiety, nervousness, and panic attack. “Nausea” includes nausea andvomiting. “Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominaldiscomfort.
Other Adverse Reactions Observed During the Premarketing eva luation of SUNOSIOther 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 elsewherein the labeling, 2) for which a drug cause was remote, 3) which were so general as to beuninformative, or 4) which were not considered to have clinically significant implications.
Narcolepsy population:
Psychiatric Disorders: agitation, bruxism, irritabilityRespiratory, thoracic and mediastinal disorders: cough
Skin and subcutaneous tissue disorders: hyperhidrosisGeneral disorders and administration site conditions: feeling jittery, thirst, chest discomfort,chest pain
Investigations: weight decreasedOSA population:
Psychiatric disorders: bruxism, restlessness
Nervous system disorders: disturbances in attention, tremorRespiratory, thoracic and mediastinal disorders: cough, dyspneaGastrointestinal disorders: constipation, vomitingInvestigations: weight decreasedDose-Dependent Adverse ReactionsIn 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 andGreater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in
Narcolepsy and OSA
Placebo SUNOSI 37.5 mg SUNOSI 75 mg SUNOSI 150 mg
N = 226
(%)
N = 58*
(%)
N = 120
(%)
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
* In OSA only.
** “Headache” includes headache, tension headache, and head discomfort. “Nausea” includes nausea and vomiting.
Adverse Reactions Resulting in Discontinuation of Treatment
In the 12-week placebo-controlled clinical trials, 11 of the 396 patients (3%) who receivedSUNOSI 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 morethan 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 showsmaximum mean changes in blood pressure and heart rate recorded at sessions where theMaintenance of Wakefulness Test (MWT) was administered [see Clinical Studies (14)]. Table 5summarizes 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory heart ratemonitoring performed in the outpatient setting.
Table 4: Maximal Mean Changes in Blood |
