ents with SUNOSI who have a history of psychosis or bipolar disorders.
Patients with moderate or severe renal impairment may be at a higher risk of psychiatricsymptoms because of the prolonged half-life of SUNOSI [see Dosage and Administration (2.5),Clinical Pharmacology (12.3)].
Patients treated with SUNOSI should be observed for the possible emergence or exacerbation ofpsychiatric symptoms. If psychiatric symptoms develop in association with the administration ofSUNOSI, consider dose reduction or discontinuation of SUNOSI.
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)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in clinical trials of a drug cannot be directly compared to rates in the clinical trials ofanother drug and may not reflect the rates observed in practice.
The safety of SUNOSI has been eva luated in 930 patients (ages 18 to 75 years) with narcolepsyor OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebocontrolledtrials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily. Informationprovided below is based on the pooled 12-week placebo-controlled studies in patients withnarcolepsy or OSA.
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported morefrequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populationswere headache, nausea, decreased appetite, anxiety, and insomnia.
Table 1 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently inSUNOSI-treated patients than in placebo-treated patients in the narcolepsy population.
Table 1: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater thanPlacebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy(75 mg and 150 mg)
Narcolepsy
System Organ Class
Placebo
N = 108
(%)
SUNOSI
N = 161
(%)
Metabolism and Nutrition
Disorders
Decreased appetite 1 9
Psychiatric Disorders
Insomnia* 4 5
Anxiety* 1 6
Nervous System Disorders
Headache* 7 16
Cardiac Disorders
Palpitations 1 2
Gastrointestinal Disorders
Nausea* 4 7
Dry mouth 2 4
Constipation 1 3
* “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.
Table 2 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently inSUNOSI-treated patients than in placebo-treated patients in the OSA population.
Table 2: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater thanPlacebo in Pooled 12-Week Placebo-Controlled Clinical Trials in OSA
(37.5 mg, 75 mg, and 150 mg)
OSA
System Organ Class
Placebo
N = 118
(%)
SUNOSI
N = 235
(%)
Metabolism and Nutrition
Disorders
Decreased appetite 1 6
Psychiatric Disorders
Anxiety* 1 4
Irritability 0 3
Nervous System Disorders
Dizziness 1 2
Cardiac Disorders
Palpitations 0 3 |
