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Sunosi

Generic Name: Solriamfetol Hydrochloride
Class: Wakefulness-promoting Agents
Chemical Name: [(2R)-2-amino-3-phenylpropyl] carbamate
Molecular Formula: C10H14N2O2
CAS Number: 178429-62-4

Medically reviewed by Drugs.com. Last updated on Jul 1, 2019.

Introduction

Solriamfetol hydrochloride is a wakefulness-promoting agent.

Uses for Sunosi

Solriamfetol hydrochloride has the following uses:

Solriamfetol hydrochloride is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).1

Solriamfetol hydrochloride has the following limitations of use:

Solriamfetol hydrochloride is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure [CPAP]) for at least one month prior to initiating solriamfetol hydrochloride for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with solriamfetol hydrochloride. Solriamfetol hydrochloride is not a substitute for these modalities.1

Sunosi Dosage and Administration

General

Solriamfetol hydrochloride is available in the following dosage form(s) and strength(s):

Tablets: 75 mg (functionally scored) and 150 mg.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

Prior to initiating treatment with solriamfetol hydrochloride, ensure that blood pressure is adequately controlled.1

Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep.1

Starting dose for patients with narcolepsy: 75 mg once daily.1

Starting dose for patients with OSA: 37.5 mg once daily.1

Dose may be increased at intervals of at least 3 days.1

Maximum dose is 150 mg once daily.1

Moderate renal impairment: Starting dose is 37.5 mg once daily. May increase to 75 mg once daily after at least 7 days.1

Severe renal impairment: Starting dose and maximum dose is 37.5 mg once daily. 1

End stage renal disease (ESRD): Not recommended.1

Cautions for Sunosi

Contraindications

Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.1

Warnings/Precautions

Blood Pressure and Heart Rate Increases

Solriamfetol hydrochloride increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion.1

Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular events (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).1

Assess blood pressure and control hypertension before initiating treatment with solriamfetol hydrochloride. Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension. Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and cerebrovascular disease, pre-existing hypertension, and patients with advanced age. Use caution with other drugs that increase blood pressure and heart rate.1

Periodically reassess the need for continued treatment with solriamfetol hydrochloride. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of solriamfetol hydrochloride or other appropriate medical intervention, consider discontinuation of solriamfetol hydrochloride.1

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 hydrochloride.1

Psychiatric Symptoms

Psychiatric adverse reactions have been observed in clinical trials with solriamfetol hydrochloride, including anxiety, insomnia, and irritability.1

Solriamfetol hydrochloride has not been evaluated in patients with psychosis or bipolar disorders. Exercise caution when treating patients with solriamfetol hydrochloride who have a history of psychosis or bipolar disorders.1

Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life of solriamfetol hydrochloride.1

Patients treated with solriamfetol hydrochloride should be observed for the possible emergence or exacerbation of psychiatric symptoms. If psychiatric symptoms develop in association with the administration of solriamfetol hydrochloride, consider dose reduction or discontinuation of solriamfetol hydrochloride.1

Specific Populations

Pregnancy

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to solriamfetol hydrochloride during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.SunosiPregnancyRegistry.com.1

Risk Summary: Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m2 body surface area. Oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the MRHD based on mg/m2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring. 1

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.1

Animal Data: Solriamfetol was administered orally to pregnant rats during the period of organogenesis at 15, 67, and 295 mg/kg/day, which are approximately 1, 4, and 19 times the MRHD based on mg/m2 body surface area. Solriamfetol at ≥ 4 times the MRHD caused maternal toxicity that included hyperactivity, significant decreases in body weight, weight gain, and food consumption. Fetal toxicity at these maternally toxic doses included increased incidence of early resorption and post-implantation loss, and decreased fetal weight. Solriamfetol was teratogenic at 19 times the MRHD; it increased the incidence of fetal malformations that included severe sternebrae mal-alignment, hindlimb rotation, bent limb bones, and situs inversus. This dose was also maternally toxic. The no-adverse-effect level for malformation is 4 times and for maternal and embryofetal toxicity is approximately 1 times the MRHD based on mg/m2 body surface area. 1

Solriamfetol was administered orally to pregnant rabbits during the period of organogenesis at 17, 38, and 76 mg/kg/day, which are approximately 2, 5, and 10 times the MRHD based on mg/m2 body surface area. Solriamfetol at 10 times the MRHD caused maternal toxicity of body weight loss and decreased food consumption. Solriamfetol was teratogenic at ≥ 5 times the MRHD, it caused fetal skeletal malformation (slight-to-moderate sternebrae mal-alignment) and decreased fetal weight. The no-adverse-effect level for malformation and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the MRHD based on mg/m2 body surface area. 1

Solriamfetol was administered orally to pregnant rats during the period of organogenesis from gestation day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which are approximately 2, 7, and 22 times the MRHD based on mg/m2 body surface area. At ≥ 7 times the MRHD, solriamfetol caused maternal toxicity that included decreased body weight gain, decreased food consumption, and hyperpnea. At these maternally toxic doses, fetal toxicity included increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight. Developmental toxicity in offspring after lactation day 20 included decreased body weight, decreased weight gain, and delayed sexual maturation. Mating and fertility of offspring were decreased at maternal doses 22 times the MRHD without affecting learning and memory. The no-adverse-effect level for maternal and developmental toxicity is approximately 2 times the MRHD based on mg/m2 body surface area.1

Lactation

Risk Summary: There are no data available on the presence of solriamfetol or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. 1

Solriamfetol is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for solriamfetol hydrochloride and any potential adverse effects on the breastfed child from solriamfetol hydrochloride or from the underlying maternal condition.1

Clinical Considerations: Monitor breastfed infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.1

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Clinical studies of solriamfetol hydrochloride in pediatric patients have not been conducted. 1

Geriatric Use

Of the total number of patients in the narcolepsy and OSA clinical studies treated with solriamfetol hydrochloride, 13% (123/930) were 65 years of age or over. 1

No clinically meaningful differences in safety or effectiveness were observed between elderly and younger patients.1

Solriamfetol is predominantly eliminated by the kidney. Because elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on eGFR in these patients. Consideration should be given to the use of lower doses and close monitoring in this population.1

Renal Impairment

Dosage adjustment is not required for patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m2). Dosage adjustment is recommended for patients with moderate to severe renal impairment (eGFR 15-59 mL/min/1.73 m2). Solriamfetol hydrochloride is not recommended for patients with end stage renal disease (eGFR <15 mL/min/1.73 m2).1

Common Adverse Effects

Most common adverse reactions (≥ 5% and greater than with placebo): headache, nausea, decreased appetite, insomnia, and anxiety.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Drugs that increase blood pressure and/or heart rate and dopaminergic drugs: Use caution when co-administering with solriamfetol hydrochloride.1

Actions

Mechanism of Action

The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).1

Advice to Patients

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).1

Advise patients that solriamfetol hydrochloride is a federally controlled substance because it has the potential to be abused. Advise patients to keep their medication in a secure place and to dispose of unused solriamfetol hydrochloride as recommended in the Medication Guide.1

Inform patients that solriamfetol hydrochloride is not indicated to treat the airway obstruction in OSA and they should use a primary OSA therapy, such as CPAP, as prescribed to treat the underlying obstruction. Solriamfetol hydrochloride is not a substitute for primary OSA therapy.1

Instruct patients that solriamfetol hydrochloride can cause elevations of their blood pressure and pulse rate and that they should be monitored for such effects.1

Instruct patients to contact their healthcare provider if they experience, anxiety, insomnia, irritability, agitation, or signs of psychosis or bipolar disorders.1

Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain.1

Additional Information

AHFSfirstRelease. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Solriamfetol hydrochloride is subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IVI) drug.1

Solriamfetol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablet, Film Coated

75 mg

Sunosi

Jazz Pharmaceuticals Inc.

150 mg

Sunosi

Jazz Pharmaceuticals Inc.

AHFS Drug Information. © Copyright 2020, Selected Revisions July 1, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Jazz Pharmaceuticals, Inc. SUNOSI (solriamfetol) ORAL prescribing information. Palo Alto, CA; 2019 Jun. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f30ab12-20e1-4391-9359-24b23a21578d

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