Patients with Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Blood Pressure and Heart Rate Increases
5.2 Psychiatric Symptoms
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase (MAO) Inhibitors
7.2 Drugs that Increase Blood Pressure and/or Heart Rate
7.3 Dopaminergic Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Narcolepsy
14.2 Obstructive Sleep Apnea (OSA)
14.3 Maintenance of Efficacy in Narcolepsy and OSA
16 HOW SUPPLIED / STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepinessassociated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)].
Limitations of use
SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that theunderlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP))for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities totreat the underlying airway obstruction should be continued during treatment with SUNOSI.
SUNOSI is not a substitute for these modalities.
2 DOSAGE AND ADMINISTRATION
2.1 Important Considerations Prior to Initiating Treatment
Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [seeWarnings and Precautions (5.1)].
2.2 General Administration Instructions
Administer SUNOSI orally upon awakening with or without food. Avoid taking SUNOSI within9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in theday.
SUNOSI 75 mg tablets are functionally scored tablets that can be split in half (37.5 mg) at thescore line.
2.3 Dosage in Narcolepsy
Initiate SUNOSI at 75 mg once daily in adults with narcolepsy. The recommended dose rangefor SUNOSI is 75 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage ofSUNOSI may be doubled at intervals of at least 3 days. The maximum recommended dose is150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficientto outweigh dose-related adverse reactions [see Warnings and Precautions (5.1)].
2.4 Dosage in OSA
Initiate SUNOSI at 37.5 mg once daily in adults with OSA. The recommended dosage range forSUNOSI is 37.5 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage ofSUNOSI may be doubled at intervals of at least 3 days. The maximum recommended dosage is150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficientto outweigh dose-related adverse reactions [see Warnings and Precautions (5.1)].
2.5 Dosa |
