Sunosi

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  



2 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 75 mg film-coated tablets  
Sunosi 150 mg film-coated tablets  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Sunosi 75 mg film-coated tablets 
 
Each tablet contains solriamfetol hydrochloride equivalent to 75 mg of solriamfetol.  
 
Sunosi 150 mg film-coated tablets 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
  
Sunosi 75 mg film-coated tablets 
 
Yellow to dark yellow oblong tablet, 7.6 mm x 4.4 mm, with “75” debossed on one side and a score 
line on the opposite side. 
The tablet can be divided into equal doses.  
 
Sunosi 150 mg film-coated tablets 
 
Yellow oblong tablet, 9.5 mm x 5.6 mm, with “150” debossed on one side.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients 
with narcolepsy (with or without cataplexy). 
 
Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult 
patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by 
primary OSA therapy, such as continuous positive airway pressure (CPAP).  
 
4.2 Posology and method of administration 
 
Treatment should be initiated by a healthcare professional experienced in the treatment of 
narcolepsy or OSA.  
 
Sunosi is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA 
therapy should be maintained in these patients. 



3 

 
Blood pressure and heart rate should be assessed before initiating treatment with solriamfetol and 
should be monitored periodically during treatment, especially after increasing the dose. Pre-existing 
hypertension should be controlled before initiating treatment with solriamfetol and caution should be 
exercised in treating patients at higher risk of MACE, particularly patients with pre-existing 
hypertension, patients with known cardiovascular or cerebrovascular disease and elderly patients.  
 
The need for continued treatment with solriamfetol should be periodically assessed. If a patient 
experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of 
solriamfetol or other appropriate medical intervention, discontinuation of solriamfetol should be 
considered.  Caution should be exercised when using other medicinal products that increase blood 
pressure and heart rate (see section 4.5). 
 
Posology 
 
Narcolepsy 
The recommended starting dose is 75 mg once daily, upon awakening. If clinically indicated in 
patients with more severe levels of sleepiness, a starting dose of 150 mg may be considered. 
Depending on clinical response, the dose can be titrated to a higher level by doubling the dose at 
intervals of at least 3 days, with a recommended maximum daily dose of 150 mg once daily.  
 
OSA 
The recommended starting dose is 37.5 mg once daily, upon awakening. Depending on clinical 
response, the dose can be titrated to a higher level by doubling the dose at intervals of at least 3 
days, with a recommended maximum daily dose of 150 mg once daily. 
 
Sunosi can be taken with or without food. 
 
Taking Sunosi less than 9 hours before bedtime should be avoided as it may affect night time sleep. 
 
Long-term use 
The need for continued treatment and the appropriate dose should be periodically assessed during 
extended treatment in patients prescribed solriamfetol. 
 
Special populations 
 
Elderly (> 65 years) 
Limited data are available in elderly patients. Consideration should be given to the use of lower doses 
and close monitoring in this population (see section 4.4).  Solriamfetol is predominantly eliminated 
by the kidney and since elderly patients are more likely to have decreased renal function, dosing may 
need to be adjusted based on creatinine clearance in these patients.  
 
Renal impairment 
Mild renal impairment (creatinine clearance of 60-89 mL/min): No dose adjustment is required. 
 
Moderate renal impairment (creatinine clearance of 30-59 mL/min): The recommended starting dose 
is 37.5 mg once daily. Dose may be increased to a maximum of 75 mg once daily after 5 days. 
 
Severe renal impairment (creatinine clearance of 15-29 mL/min): The recommended dose is 37.5 mg 
once daily.  
 
End stage renal disease (creatinine clearance <15 mL/min): Solriamfetol is not recommended for 
use in patients with end stage renal disease. 
 
Paediatric population 
The safety and efficacy of Sunosi in children and adolescents (<18 years old) have not yet been 



4 

established. No data are available. 
 
Method of administration 
 
Sunosi is for oral use. 
 
Administration of a 37.5 mg dose can be achieved by halving a 75 mg tablet using the score line. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Myocardial infarction within the past year, unstable angina pectoris, uncontrolled 

hypertension, serious cardiac arrhythmias and other serious heart problems. 
• Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI 

treatment has been discontinued (see section 4.5). 
 
4.4 Special warnings and precautions for use 
 
Psychiatric symptoms 
 
Solriamfetol has not been evaluated in patients with a history of or concurrent psychosis or bipolar 
disorders. Caution should be exercised when treating these patients due to psychiatric adverse 
reactions that could exacerbate symptoms (e.g. manic episodes) of pre-existing psychiatric disorders. 
 
Patients treated with solriamfetol should be carefully monitored for adverse reactions such as 
anxiety, insomnia and irritability. These adverse reactions were commonly observed during 
treatment initiation but tended to resolve with continued treatment. If these symptoms persist or 
worsen, dose reduction or discontinuation should be considered. 
 
Blood pressure and heart rate 
 
Analyses of data from clinical trials showed that treatment with solriamfetol increases systolic blood 
pressure, diastolic blood pressure, and heart rate in a dose dependent fashion.  
 
Epidemiological data show that chronic elevations in blood pressure increase the risk of major 
adverse cardiovascular event (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).  
 
Use in patients with unstable cardiovascular disease, serious heart arrhythmias and other serious 
heart problems is contraindicated (see section 4.3).  
 
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.  
 
Abuse 
 
Sunosi was assessed in a human abuse potential study and demonstrated low abuse potential. Results 
from this clinical study demonstrated that solriamfetol produced Drug Liking scores higher than 
placebo, but generally similar or lower than phentermine (a weak stimulant). Caution should be 
exercised when treating patients with a history of stimulant (e.g. methylphenidate, amphetamine) or 
alcohol abuse, and these patients should be monitored for signs of misuse or abuse of solriamfetol. 
 



5 

Angle closure glaucoma 
 
Mydriasis may occur in patients taking solriamfetol. Caution is advised in patients with increased 
ocular pressure or at risk of angle closure glaucoma. 
 
Women of childbearing potential or their partners 
 
Women of childbearing potential or their male partners must use effective method of contraception 
while taking solriamfetol (see section 4.6). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed (see section 5.2). 
 
Solriamfetol must not be administered concomitantly with MAOIs or within 14 days after MAOI 
treatment has been discontinued because it may increase the risk of a hypertensive reaction (see 
section 4.3). 
  
Concomitant use of medicinal products that increase blood pressure and heart rate should be used 
with caution (see section 4.4). 
 
Medicinal products that increase levels of dopamine or that bind directly to dopamine receptors 
might result in pharmacodynamic interactions with solriamfetol. Concomitant use of such medicinal 
products should be used with caution.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of solriamfetol in pregnant women. Animal 
studies have shown reproductive toxicity (see section 5.3). Sunosi is not recommended during 
pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
It is unknown whether solriamfetol is excreted into human milk. Animal studies have shown 
excretion of solriamfetol in milk. A risk to the newborns/infants cannot be excluded. A decision must 
be made whether to discontinue breast-feeding or to discontinue/abstain from Sunosi therapy taking 
into account the benefit of breast feeding for the child and the benefit of therapy for the women. 
 
Fertility 
 
The effects of solriamfetol in humans are unknown. Animal studies do not indicate direct or indirect 
harmful effects with respect to fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Minor influence on the ability to drive is expected in patients receiving stable solriamfetol doses. 
Dizziness and disturbance in attention may occur following administration of solriamfetol (see 
section 4.8). 
 
Patients with abnormal levels of sleepiness who take solriamfetol should be advised that their level of 
wakefulness may not return to normal. Patients with excessive daytime sleepiness, including those 
taking solriamfetol should be frequently reassessed for their degree of sleepiness and, if appropriate, 
advised to avoid driving or any other potentially dangerous activity, especially at the start of the 
treatment or when the dose is changed. 
 



6 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased 
appetite (6.8%).  
 
Tabulated list of adverse reactions 
 
The frequency of adverse reactions is defined using the following MedDRA frequency convention: 
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare ( ≥ 
1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available 
data). 
 
System Organ Class Adverse reactions Frequency 
Metabolism and nutrition disorders Decreased appetite Common 
Psychiatric disorders Anxiety Common 

Insomnia Common 
Irritability Common 
Bruxism Common 
Agitation Uncommon 
Restlessness Uncommon 

Nervous system disorders Headache Very common 
Dizziness Common 
Disturbance in attention Uncommon 
Tremor Uncommon 

Cardiac disorders Palpitations Common 
Tachycardia Uncommon 

Vascular Disorders Hypertension Uncommon 
Respiratory, thoracic and mediastinal disorders Cough Common 

Dyspnoea Uncommon 
Gastrointestinal disorders Nausea Common 

Diarrhoea Common 
Dry mouth Common 
Abdominal pain Common 
Constipation Common 
Vomiting Common 

Skin and subcutaneous tissue disorders Hyperhidrosis Common 
General disorders and administration site 
conditions 

Feeling jittery Common 
Chest discomfort Common 
Chest pain Uncommon 
Thirst Uncommon 

Investigations Heart rate increased Uncommon 
Blood pressure increased Common 
Weight decreased Uncommon 

 
Description of selected adverse reactions 
 
Treatment initiation 
The majority of the most frequently reported adverse reactions occurred within the first 2 weeks of 
initiating treatment and resolved for the majority of patients with a median duration of less than 2 
weeks. 
 
Dose-dependent adverse reactions 
In the 12-week clinical trials that compared doses of 37.5 mg, 75 mg and 150 mg/day of solriamfetol 
to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, 



7 

anxiety, diarrhoea and dry mouth. The dose relationships were generally similar in OSA and 
narcolepsy patients. Certain events such as anxiety, insomnia, irritability, and agitation were 
commonly observed during treatment initiation but tended to resolve with continued treatment. If 
these symptoms persist or worsen, dose reduction or discontinuation should be considered (see 
section 4.4).  
 
Discontinuation of treatment 
In the 12-week placebo-controlled clinical trials, 11 of the 396 patients (3%) who received 
solriamfetol discontinued due to an adverse reaction compared to 1 of the 226 patients (<1%) who 
received placebo. The adverse reactions leading to discontinuation that occurred in more than one 
solriamfetol-treated patients and at a higher rate than placebo were anxiety, palpitations and 
restlessness, all of which occurred with a frequency less than 1%. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There have been no reports of overdose of solriamfetol in the clinical studies. 
 
In healthy volunteers, there was one adverse reaction of mild tardive dyskinesia and one adverse 
reaction of moderate akathisia that occurred at a supratherapeutic dose of 900 mg; symptoms 
resolved after treatment discontinuation. 
 
There is no specific antidote. In the case of inadvertent overdose, symptomatic and supportive 
medical care should be provided and patients should be carefully monitored, as appropriate. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: psychoanaleptics, centrally acting sympathomimetics, ATC code: 
N06BA14  
 
Mechanism of action 
 
The mechanism(s) of solriamfetol to improve wakefulness in patients with excessive daytime 
sleepiness associated with narcolepsy or obstructive sleep apnea has not been fully characterised. 
However, its efficacy could be mediated through its activity as a dopamine and norepinephrine 
reuptake inhibitor (DNRI). 
 
Pharmacodynamic effects 
 
In vitro data 
In radioligand-binding experiments with cells expressing cloned human receptors/transporters, 
solriamfetol showed affinity for the dopamine (replicate Ki=6.3 and 14.2 µM) and norepinephrine 
transporter (replicate Ki= 3.7 and >10 µM) but no appreciable affinity to the serotonin transporter. 
Solriamfetol inhibited the reuptake of dopamine (replicate IC50=2.9 and 6.4 µM) and norepinephrine 
(IC50= 4.4 µM) but not of serotonin by these cells. 
 
In vivo animal data 
In parenteral doses resulting in clear wake-promoting effects in rats, solriamfetol increased individual 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


8 

dopamine levels in the striatum and norepinephrine levels in the prefrontal cortex, and did not show 
appreciable binding to the rat dopamine and norepinephrine transporter in an autoradiography 
experiment. 
 
Clinical efficacy and safety 
 
Narcolepsy 
Study 1, a 12-week, randomised, double-blind, placebo-controlled, parallel-group study, evaluated 
the efficacy of solriamfetol in adult patients with narcolepsy (with or without cataplexy). 
 
For entry into this study patients had to have excessive daytime sleepiness (an Epworth Sleepiness 
Scale [ESS] score greater than or equal to 10), and trouble maintaining wakefulness (mean sleep 
latency less than 25 minutes) as documented by the mean of the first 4 trials of the 40-minute 
Maintenance of Wakefulness Test (MWT) at baseline. 
 
The measures of efficacy were change from baseline to Week 12 on: ability to stay awake as 
measured by mean sleep latency on the MWT, excessive daytime sleepiness as measured by the ESS, 
and improvement in overall clinical condition as assessed by the Patient Global Impression of 
Change (PGIc) scale. The ESS is an 8-item patient-reported measure of likelihood of falling asleep in 
usual daily life activities. The PGIc is a 7-point scale ranging from “very much improved” to “very 
much worse” which assesses the patient’s report of change in their clinical condition. 
 
Patients with narcolepsy were characterised by impaired wakefulness and excessive daytime 
sleepiness, as indicated by baseline MWT mean sleep latency and ESS scores, respectively (Table 1). 
Most patients had prior use of psychostimulants. Cataplexy was present in approximately half of 
patients overall; demographic and baseline characteristics were similar between patients with 
cataplexy and those without cataplexy. 
 
In this study, patients with narcolepsy were randomised to receive solriamfetol 75 mg, 150 mg, or 300 
mg (two times the maximum recommended daily dose), or placebo once daily. At Week 12, patients 
randomised to the 150 mg dose showed statistically significant improvements on the MWT and ESS 
(co-primary endpoints), as well as on the PGIc (key secondary endpoint), compared with placebo. 
Patients randomised to receive 75 mg showed statistically significant improvement on the ESS, but 
not on the MWT or PGIc (Table 1). These effects were dose-dependent, observed at Week 1 and 
maintained over the study duration (Figure 1). In general, at the same doses, a smaller magnitude of 
effect was observed in patients with more severe baseline levels of sleepiness relative to those who 
were less severe. At Week 12, patients who were randomised to receive 150 mg of solriamfetol 
demonstrated sustained improvements in wakefulness throughout the day that were statistically 
significant compared to placebo for each of the 5 MWT trials, spanning approximately 9 hours after 
dosing. Dose-dependent improvements in the ability to conduct daily activities were observed, as 
measured by the Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10). Dosages 
above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related 
adverse reactions. 
 
Night-time sleep as measured with polysomnography was not affected by the use of solriamfetol. 
 
Table 1. Overview of Efficacy Results at Week 12 in Patients with Narcolepsy in Study 1 
 Treatment Groups 

(N) 
Mean Baseline 

Score (SD) 
Mean Change 
from Baseline 

Difference from 
Placebo (95% CI) 

P - 
Value 

MWT 
(min) 

 

Study 1   LS Mean (SE)   
Placebo (58) 6.15 (5.68) 2.12 (1.29)   
Sunosi 75 mg (59) 7.50 (5.39) 4.74 (1.34) 2.62 (-1.04, 6.28) 0.1595 
Sunosi 150 mg (55) 7.85 (5.74) 9.77 (1.33) 7.65 (3.99, 11.31) <0.000

 ESS Study 1  
  

LS Mean (SE)  
 

 
 Placebo (58) 17.3 (2.86) -1.6 (0.65)   

Sunosi 75 mg (59) 17.3 (3.53) -3.8 (0.67) -2.2 (-4.0, -0.3) 0.0211 
Sunosi 150 mg (55) 17.0 (3.55) -5.4 (0.66) -3.8 (-5.6, -2.0) <0.000

 



9 

       Percentage of 
Patients Improved* 

Percentage 
Difference from 

Placebo (95% CI) 

P - 
Value 

PGIc Study 1  
 

 
 

 
  Placebo (58) 39.7%   

 Sunosi 75 mg (59) 67.8% 28.1 (10.8, 45.5) 0.0023
†  Sunosi 150 mg (55) 78.2% 38.5 (21.9, 55.2) <0.000
 SD = Standard Deviation; SE = Standard Error; LS Mean = Least Square Mean; Difference From Placebo = LS Mean Difference 

between change from baseline between active drug and placebo. MWT results are derived from the first 4 trials of the MWT and a 
positive change from baseline represents improvement in the sleep latency time. On the ESS, a negative change from baseline 
represents improvement in excessive daytime sleepiness. *The percentage of patients improved on the PGIc includes those who 
reported very much, much and minimal improvements; 
†Nominal p-value. 

 
Figure 1: Co-Primary Efficacy Endpoints in Patients with Narcolepsy in Study 1 

 
 

 
OSA 
Study 2, a 12-week, randomised, double blind, placebo-controlled parallel-group study, evaluated 
the efficacy of solriamfetol in adult patients with OSA. The co-primary and key secondary 
endpoints in this study were identical to Study 1. Study 3 was a 6-week, randomised-withdrawal, 
double-blind, placebo-controlled study of the efficacy of solriamfetol in adult patients with OSA. 
The measures of efficacy in the randomised withdrawal period were change from the beginning to 
the end of the randomised-withdrawal period on the MWT, the ESS, and worsening in overall 
clinical condition as assessed by the PGIc. 
 
For entry into both studies, patients had to have excessive daytime sleepiness (ESS score ≥10) and 
trouble maintaining wakefulness (mean sleep latency <30 minutes as documented by the mean of the 
first 4 trials of the MWT) at baseline. Patients were eligible if they: 1) were currently using a 
primary OSA therapy (at any level of adherence); 2) had previously used a primary therapy for at 
least one month with at least one documented adjustment to the therapy; or 3) had undergone a 



10 

surgical intervention in an attempt to treat the underlying obstruction. Patients were encouraged to 
stay on their current primary OSA therapy at the same level of use throughout the study. Patients 
were excluded only on the basis of their primary therapy use if they had refused to try a primary 
therapy such as CPAP, an oral appliance, or a surgical intervention to treat their underlying 
obstruction. 
 
In Study 2, patients with OSA were characterised by impaired wakefulness and excessive daytime 
sleepiness (EDS), as indicated by baseline MWT mean sleep latency and ESS scores, respectively 
(Table 2). Approximately 71% of patients were adherent (e.g. ≥4 hours per night on ≥70% of 
nights); demographic and baseline characteristics were similar between patients regardless of 
adherence to primary OSA therapy. At baseline, primary OSA therapy was used by approximately 
73% of patients; of these patients, 92% of patients were using positive airway pressure (PAP). 
 
Patients were randomised to receive solriamfetol 37.5 mg, 75 mg, 150 mg, 300 mg (two times the 
maximum recommended daily dose), or placebo once daily. At Week 12, patients randomised to the 
75 mg and150 mg dose arms showed statistically significant improvements on the MWT and ESS 
(co-primary endpoints), as well as on the PGIc (key secondary endpoint), compared with placebo 
(Table 2). Patients randomised to 37.5 mg solriamfetol showed statistically significant improvements 
based on the MWT and ESS. These effects were observed at Week 1, maintained over the study 
duration and were dose-dependent (Figure 2). At Week 12, patients who were randomised to receive 
75 mg and 150 mg  of Sunosi demonstrated sustained improvements in wakefulness throughout the 
day that were statistically significant compared to placebo for each of the 5 MWT trials, spanning 
approximately 9 hours after dosing.  Dose- dependent improvements in the ability to conduct daily 
activities were observed, as measured by the FOSQ-10. Dosages above 150 mg daily do not confer 
increased effectiveness sufficient to outweigh dose-related adverse reactions. 
 
Night-time sleep as measured with polysomnography was not affected by the use of solriamfetol in 
Study 2. No clinically meaningful changes in patient use of primary OSA therapy were observed 
across the 12-week study period in any treatment group. Adherence/non-adherence to primary OSA 
therapy did not suggest evidence of differential efficacy. 
 
In Study 3, baseline demographics and disease characteristics were similar to the study population in 
Study 2. The dose was initiated at 75 mg once daily and could be titrated up one dose level in 
intervals no shorter than every 3 days, according to efficacy and tolerability, to 150 mg or 300 mg. 
Patients could also titrate down to 75 mg or 150 mg. Patients treated with solriamfetol remained 
improved, whereas placebo-treated patients worsened (LS mean difference of 11.2 minutes on MWT 
and -4.6 on ESS; both p<0.0001) during the randomised-withdrawal period after 4 weeks of open-
label treatment. Fewer patients treated with solriamfetol reported worsening on the PGIc (percentage 
difference of 30%; p=0.0005). 
 
Table 2. Overview of Efficacy Results at Week 12 in Patients with OSA in Study 2 

 Treatment Group 
(N) 

Mean Baseline 
Score (SD) 

Mean Change 
from Baseline 

Difference from 
Placebo (95% CI) 

P - 
Value 

 

MWT 
(min) 

 
Placebo (114) 
Sunosi 37.5 mg (56) 
Sunosi 75 mg (58) 
Sunosi 150 mg (116) 

 
12.58 (7.14) 
13.6 (8.15) 
12.44 (6.91) 
12.54 (7.18) 

LS Mean (SE)  
- 

4.53 (1.16, 7.90) 
8.87 (5.59, 12.14) 

10.74 (8.05, 13.44) 

 
- 

0.0086 
<0.0001 
<0.0001 

0.21 (1.0) 
4.74 (1.42) 
9.08 (1.36) 
10.96 (0.97) 

 
 

ESS 

 
Placebo (114) 
Sunosi 37.5 mg (56) 
Sunosi 75 mg (58) 
Sunosi 150 mg (116) 

 
15.6 (3.32) 
15.1 (3.53) 
15.0 (3.51) 
15.1 (3.37) 

LS Mean (SE)  
- 

-1.9 (-3.4, -0.3) 
-1.7 (-3.2, -0.2) 
-4.5 (-5.7, -3.2) 

 
- 

0.0161 
0.0233 

<0.0001 

-3.3 (0.45) 
-5.1 (0.64) 
-5.0 (0.62) 
-7.7 (0.44) 



11 

  Percentage of Patients 
Improved* 

Percentage 
Difference from 

Placebo (95% CI) 

P - 
Value 

 

PGIc 

Placebo (114) 
Sunosi 37.5 mg (56) 
Sunosi 75 mg (58) 
Sunosi 150 mg (116) 

49.1% 
55.4% 
72.4% 
89.7% 

- 
6.2 (-9.69, 22.16) 
23.3 (8.58, 38.01) 

40.5 (29.81, 51.25) 

- 
0.4447 
0.0035 
<0.0001 

 
SD = Standard Deviation; SE = Standard Error; LS Mean = Least Square Mean; Difference From Placebo = LS Mean Difference on 
change from baseline between active drug and placebo. MWT results are derived from the first 4 trials of the MWT and a positive 
change from baseline represents improvement in the sleep latency time. On the ESS, a negative change from baseline represents 
improvement in excessive daytime sleepiness. *The percentage of patients improved on the PGIc includes those who reported very 
much, much and minimal improvements. 
 

Figure 2: Co-Primary Efficacy Endpoints in Patients with OSA in Study 2 
 

 
 
 
 
Long-term efficacy in narcolepsy and OSA 
Study 4 was a long-term safety and maintenance of efficacy study for up to a year of treatment with 
solriamfetol, including a 2-week randomised-withdrawal, placebo-controlled period after at least 6 
months of treatment with solriamfetol, in adult patients with narcolepsy or OSA who had 
completed a prior trial. 
 
The measures of efficacy in the randomised withdrawal period were change from the beginning to 
the end of the randomised-withdrawal period on the ESS and worsening in overall clinical 
condition as assessed by the PGIc. Dose initiation and titration was identical to Study 3.  
 
Patients treated with solriamfetol remained improved, whereas placebo-treated patients worsened 
(LS mean difference of -3.7 on ESS; p<0.0001) during the randomised-withdrawal period after at 



12 

least 6 months of open-label treatment. Fewer patients treated with solriamfetol reported worsening 
on the PGIc (percentage difference of -36.2%; p<0.0001). These results demonstrate long-term 
maintenance of efficacy with continued solriamfetol treatment, and a reversal of treatment benefit 
upon discontinuation of that treatment. 
 
For patients who were using a primary OSA therapy at the beginning of the study, primary OSA 
therapy use did not change over the course of the long-term study. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Sunosi in one or more subsets of the paediatric population from 6 to less than 18 years of age in 
symptomatic treatment of excessive daytime sleepiness in narcolepsy (see section 4.2 for information 
on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
The oral bioavailability of solriamfetol is approximately 95% with peak plasma concentrations 
occurring at a median Tmax of 2 hours (range 1.25 to 3 hours) under fasted conditions. 
 
Ingestion of solriamfetol with a high-fat meal resulted in minimal changes in Cmax and AUC; 
however, a delay of approximately 1 hour was observed in Tmax. The results show that solriamfetol 
can be taken without regard to food. 
 
Distribution 
 
The apparent volume of distribution of solriamfetol is approximately 198.7 L, indicating extensive 
tissue distribution beyond the vascular compartment. Plasma protein binding ranged from 13.3% to 
19.4% over the solriamfetol concentration range of 0.059 to 10.1 µg/mL in human plasma. The mean 
blood-to-plasma concentration ratio ranged from 1.16 to 1.29, suggesting a small extent of binding of 
solriamfetol to blood cells. 
 
Biotransformation 
 
Solriamfetol is minimally metabolised in humans. 
 
Interactions 
With the exception of weak inhibition of CYP2D6 (IC50 of 360 µM), solriamfetol is not a substrate 
or inhibitor of any of the major CYP enzymes and does not induce CYP1A2, 2B6, 3A4 or UGT1A1 
enzymes at clinically relevant concentrations. Solriamfetol does not appear to be a substrate or 
inhibitor of membrane transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1 or OAT3. 
Solriamfetol is primarily excreted unchanged in the urine and is a low-affinity substrate of multiple 
renal cationic active substance transporters, without strong affinity for any individual transporter 
tested (OCT2, MATE1, OCTN1 and OCTN2). Solriamfetol is not an inhibitor of renal transporters 
OCT1, MATE2-K, OCTN1 or OCTN2 but is a weak inhibitor of OCT2 (IC50 of 146 µM) and 
MATE1 (IC50 of 211 µM). Taken together, these results show that clinically relevant PK drug 
interactions are unlikely to occur in patients taking solriamfetol. 
 
Elimination 
 
The apparent mean elimination half-life of solriamfetol is 7.1 hours, and the apparent total clearance 
is approximately 19.5 L/h. Renal clearance for solriamfetol is approximately 18.2 L/h. 
 
In a human mass-balance study, approximately 95% of the dose was recovered in urine as unchanged 
solriamfetol and 1% or less of the dose was recovered as the minor inactive metabolite N-acetyl 



13 

solriamfetol. Renal clearance represented the majority of apparent total clearance and exceeded 
creatinine clearance by approximately 3-fold, indicating that active tubular secretion of the parent 
drug is likely the major elimination pathway. 
 
Linearity/non-linearity 
 
Solriamfetol exhibits linear pharmacokinetics over the clinical dose range. Steady state is reached in 
3 days, and once-daily administration of 150 mg is expected to result in minimal solriamfetol 
accumulation (1.06 times single-dose exposure). 
 
Special populations 
 
Renal impairment 
Compared to subjects with normal renal function (eGFR≥90 mL/min/1.73 m2), AUC of solriamfetol 
was higher by approximately 1.5-, 2.3-, and 4.4-fold, and t1/2 increased approximately 1.2-, 1.9-, and 
3.9- fold in patients with mild (eGFR 60-89 mL/min/1.73 m2), moderate (eGFR 
30-59 mL/min/1.73 m2), or severe (eGFR<30 mL/min/1.73 m2) renal impairment, respectively. In 
general, mean Cmax and median Tmax values were not affected by renal impairment.  
 
Compared to subjects with normal renal function (eGFR≥90 mL/min/1.73 m2), AUC of solriamfetol  
was higher by approximately 6.2- and 4.6-fold, respectively, in patients with ESRD without 
hemodialysis and in patients with ESRD undergoing hemodialysis, and t1/2 increased at least 13-
fold. Solriamfetol is not recommended for use in patients with ESRD. In patients with ESRD, an 
average of 21% of solriamfetol was removed by hemodialysis. 
 
Age, gender, race 
Population PK analysis indicated that the intrinsic covariates of age, gender, and race do not have 
clinically relevant effects on the pharmacokinetics of solriamfetol. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity, 
and male and female fertility.  
 
Repeated dose toxicity studies with daily oral application were conducted in mice (duration 3 months, 
NOAEL 17 mg/kg/day), rats (duration 6 months with a 3-month recovery period, NOAEL not 
established, LOAEL 29 mg/kg/day) and dogs (duration 12 months with a 3-month recovery period, 
NOAEL not established, LOAEL 8 mg/kg/day). AUC-based safety factors for solriamfetol derived 
from these studies (based on comparison with clinical AUC at the maximum recommended human 
dose of 150 mg/day) were <1 for mice (based on NOAEL) and <2 for rats and dogs (based on 
LOAEL), mainly due to exaggerated pharmacological effects of solriamfetol on CNS activity. 
 
Long-term carcinogenicity studies have been performed in mice, treated with oral solriamfetol doses 
of 20, 65 and 200 mg/kg/day for up to 104 weeks, and in rats, treated with oral solriamfetol doses of 
35, 80 and 200 mg/kg/day for up to 101 weeks. Solriamfetol did not increase the incidence of 
neoplastic findings in these lifetime carcinogenicity assays. AUC-based safety margins at the high 
dose to the maximal recommended human dose (MRHD, 150 mg/day) were about 7.8 in mice and 
about 20.7 in rats. In the light of negative genotoxicity and no increase of tumour incidence in both 
carcinogenicity studies, it can be concluded that solriamfetol does not pose a carcinogenic risk to 
humans. Compared to controls, survival rate was decreased in solriamfetol-treated (male) mice, 
maximal at a dose of 65 mg/kg/day (AUC-based safety margin to MRHD about 2.9), but not in 
solriamfetol-treated rats. 
 
Embryofoetal development 
 
Possible effects on embryofoetal development were investigated in pregnant rats and rabbits. 
Embryofoetal toxicity (increased postimplantation loss in rats, increased incidence of skeletal 



14 

alterations that included sternebrae malalignment in rats and rabbits, hindlimb rotation and bent 
bones in rats, and decreased foetal weights in both species) and situs inversus in rats was only 
evident in the presence of maternal toxicity (decreased body weights). Whether embryotoxicity was a 
consequence of maternal toxicity or a direct effect of solriamfetol cannot be determined. In a 
distribution study in pregnant rats 14C-solriamfetol was detected in foetal membrane (around twice 
as high as in blood), placenta and whole foetus (nearly similar to blood concentration) and thus a 
direct toxic effect on the foetus cannot be excluded. In rats the exposure margins at the maternal and 
developmental NOAEL are below the human exposure (0.6 – 0.7 based on AUC) at the MRHD, 
while in rabbits the exposure margins at the maternal and developmental NOAEL is < 6 (based on 
mg/m2 body surface area). 
 
Prenatal and postnatal Development 
 
In rats exposure levels (AUC) above 0.6 – 0.7 times the human exposure (AUC) at the MRHD during 
pregnancy and lactation resulted in maternal toxicity and adverse effects on growth and development 
in the offspring. At exposure levels (AUC) 8 to 12 times the human exposure (AUC) at the MRHD 
no long-term effects on learning and memory were observed, but mating and pregnancy indices of 
the offspring were decreased. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Hydroxypropyl cellulose  
Magnesium stearate 
 
Film coating 
 
Poly(vinyl alcohol) Macrogol 
Talc 
Titanium dioxide (E 171) 
Iron oxide yellow (E 172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years  
Bottles after first opening: 120 days 
 
6.4 Special precautions for storage 
 
Blisters: This medicinal product does not require any special storage conditions. 
 
Bottles: Once opened, use within 4 months. Keep the container tightly closed in order to protect from 
moisture. 
 
6.5 Nature and contents of container 
 
PVC/PCTFE//Aluminium blister. 
Packs containing 7, 28 or 56 film-coated tablets. 
 



15 

High density polyethylene (HDPE) bottle with polypropylene (PP) child-resistant cap with integrated 
silica gel desiccant. Each bottle contains 30 or 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals Ireland Ltd 
5th Floor 
Waterloo Exchange 
Waterloo Road 
Dublin 
D04 E5W7 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/001 
EU/1/19/1408/002 
EU/1/19/1408/003 
EU/1/19/1408/004 
EU/1/19/1408/005 
EU/1/19/1408/006 
EU/1/19/1408/007 
EU/1/19/1408/008 
EU/1/19/1408/009 
EU/1/19/1408/010 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 
  

http://www.ema.europa.eu/


16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



17 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Jazz Pharmaceuticals Ireland Ltd 
5th Floor 
Waterloo Exchange 
Waterloo Road 
Dublin 
D04 E5W7 
Ireland 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
  



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 
 
 
 
 
 
 
 
 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON - PACK OF 7, 28 and 56 TABLETS 75 mg STRENGTH  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 75 mg film-coated tablets  
solriamfetol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride equivalent to 75 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4.  PHARMACEUTICAL FORM AND CONTENTS  
 
7 film-coated tablets 
28 film-coated tablets 
56 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 



21 

APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals Ireland Ltd 
5th Floor Waterloo Exchange  
Waterloo Road Dublin 
D04 E5W7 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/001 
EU/1/19/1408/002 
EU/1/19/1408/003 
 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Sunosi 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS - 75 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 75 mg tablets  
solriamfetol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
  



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON - PACK OF 7, 28 and 56 TABLETS 150 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 150 mg film-coated tablets  
solriamfetol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
56 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



24 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals Ireland Ltd  
5th Floor Waterloo Exchange  
Waterloo Road Dublin 
D04 E5W7 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/006 
EU/1/19/1408/007 
EU/1/19/1408/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Sunosi 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



25 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS - 150 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 150 mg tablets  
solriamfetol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON - PACK OF 30 and 100 TABLETS 75 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 75 mg film-coated tablets  
solriamfetol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets  
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening of the bottle use within 120 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from moisture. 
 
 



27 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals Ireland Ltd  
5th Floor Waterloo Exchange  
Waterloo Road Dublin 
D04 E5W7 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/004 
EU/1/19/1408/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Sunosi 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



28 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLES - 75 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 75 mg film-coated tablets  
solriamfetol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets  
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening of the bottle use within 120 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from moisture. 
 
 



29 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/004 
EU/1/19/1408/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
  



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON - PACK OF 30 and 100 TABLETS 150 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 150 mg film-coated tablets  
solriamfetol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets  
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening of the bottle use within 120 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from moisture. 
 
 



31 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals Ireland Ltd  
5th Floor Waterloo Exchange  
Waterloo Road Dublin 
D04 E5W7 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/009 
EU/1/19/1408/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Sunosi 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 
  



32 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLES -150 mg STRENGTH 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sunosi 150 mg film-coated tablets  
solriamfetol 
 
 
2. . STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets  
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening of the bottle use within 120 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the container tightly closed in order to protect from moisture. 
 
 
 



33 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Jazz Pharmaceuticals  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1408/009 
EU/1/19/1408/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
  



34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B.  PACKAGE LEAFLET 
 

 
  



35 

Package leaflet: Information for the patient 
 

Sunosi 75 mg film-coated 
tablets Sunosi 150 mg film-
coated tablets solriamfetol 

 
This medicine is subject to additional monitoring. This will allow quick identification of 

new safety information. You can help by reporting any side effects you may get. See the end of 
section 4 for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
 
1. What Sunosi is and what it is used for 
2. What you need to know before you take Sunosi 
3. How to take Sunosi 
4. Possible side effects 
5. How to store Sunosi 
6. Contents of the pack and other information 
 
 
1. What Sunosi is and what it is used for 
 
Sunosi contains the active substance solriamfetol. Solriamfetol, increases the amount of the natural 
substances dopamine and norepinephrine in your brain. Sunosi helps you to stay awake and to feel 
less sleepy. 
 
It is used 

• in adults with narcolepsy, a condition that causes you to suddenly and unexpectedly feel very 
sleepy at any time. Some patients with narcolepsy also have symptoms of cataplexy (when 
muscles become weak in response to emotions such as anger, fear, laughter or surprise, 
sometimes leading to collapse). 
 

• to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients 
with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by 
primary OSA therapy, such as continuous positive airway pressure (CPAP).  

 
 
2. What you need to know before you take Sunosi  
 
Do not take Sunosi if you: 
• are allergic to solriamfetol or any of the other ingredients of this medicine (listed in section 

6) 
• had a heart attack in the past 1 year 
• have serious heart problems, such as chest pain of recent onset, or chest pain that is lasting 

longer or is more severe than usual, high blood pressure not properly controlled with 
medicines, serious irregular heart beat or other serious heart problems 



36 

• are taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAOI) for 
depression or Parkinson’s disease, or have taken an MAOI in the last 14 days. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Sunosi if you have or have had: 
 

• mental health problems, including psychosis (altered sense of what is real) and extreme 
changes in mood (bipolar disorder) 

• heart problems, heart attack or stroke 
• high blood pressure 
• alcoholism or any drug abuse or dependence 
• an eye condition called angle closure glaucoma. 

 
Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is 
because Sunosi may make some of these problems worse. Your doctor will want to monitor how the 
medicine affects you. 
 
Sunosi does not replace your OSA primary treatment such as CPAP. You should continue to use 
such treatment as well as Sunosi. 
 
Children and adolescents 
Sunosi is not recommended in children or adolescents under 18 years of age. The safety and 
efficacy are not yet known in this age group. 
 
Other medicines and Sunosi 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Do not take Sunosi if: 

• you are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) for depression or 
Parkinson’s disease, or have taken an MAOI in the last 14 days because taking an MAOI 
with Sunosi may increase your blood pressure. 

 
Check with your doctor or pharmacist if you are taking medicines that can increase your blood 
pressure or heart rate, or if you are taking dopaminergic agents (e.g. pramipexole, levodopa, 
methylphenidate) which are used to treat Parkinson’s disease, depression, restless leg syndrome and 
ADHD.  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Sunosi should not be used during pregnancy or in women of childbearing potential not using 
effective contraception. 
 
You should not use Sunosi during breast-feeding. You and your doctor must decide whether to 
avoid breast-feeding or to stop or avoid Sunosi therapy, taking into account the benefit of breast-
feeding for you and your child and the benefit of therapy for you. 
 
Driving and using machines 
 
You may feel dizzy or your ability to concentrate may be impaired, take special care when driving or 
using machines.  
 
Talk to your doctor or pharmacist if you are not sure how your underlying condition or this 
medicine affects you with activities that require attention, such as driving and handling machinery: 



37 

• at the beginning of treatment 
• if your dose is changed 

 
 
3. How to take Sunosi 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure. 
 
How much Sunosi to take 
 
Your doctor will advise you on the dose of Sunosi to take. 

• For narcolepsy, treatment is normally started with a dose of 75 mg once per day, in the 
morning when you wake up. Some patients may need a 150-mg starting dose. Your 
doctor will advise you if this applies to you. Your doctor may prescribe you a lower dose 
of 37.5 mg. You can get this dose by taking half of one 75 mg tablet. The tablet should be 
broken using the score line. 
 

• For OSA, treatment is normally started with a dose of 37.5 mg once per day, in the 
morning when you wake up. You can get this dose by taking half of one 75 mg tablet. 
The tablet should be broken using the score line. 
 

• After at least 3 days’ treatment, your doctor may increase your daily dose to the most 
appropriate dose. 

 
The recommended maximum dose of Sunosi is 150 mg daily. 
 
Elderly (aged more than 65 years) 
Take the usual daily dose unless you have kidney problems (see below “Patients with kidney 
problems”). 
 
Patients with kidney problems 
If you have kidney problems your doctor may need to adjust the dose. 
 
Taking Sunosi 

• Sunosi is for oral use 
• Take Sunosi by mouth in the morning when you wake up. 
• You can take Sunosi with food or between meals. 

 
How long to take Sunosi 
You should continue to take Sunosi for as long as you are told to by your doctor. 
 
If you take more Sunosi than you should 
The following symptoms were observed when patient received Sunosi 900mg (6 times the 
maximum daily dose): uncontrollable movements (tardive dyskinesia) and feeling restless and 
unable to keep still (akathisia). These symptoms resolved when Sunosi was stopped. 
 
Contact your doctor or nearest emergency department immediately for advice. Take this leaflet and 
any remaining tablets with you. 
 
If you forget to take Sunosi 
If you forget to take your medicine at the usual time, you can still take it if it is more than 9 hours 
before bedtime. Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Sunosi 
Discuss with your doctor before you stop taking Sunosi. 



38 

 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common side effects (may affect more than 1 in 10 people) 
• Headache 
 
Common side effects (may affect up to 1 in 10 people) 
• Anxiety, difficulty sleeping, irritability, dizziness, feeling jittery, excessive sweating 
• Fast or irregular heart beats, also called palpitations, chest discomfort 
• High blood pressure  
• Feeling sick, diarrhoea, stomach pain, constipation, vomiting 
• Cough, clenching or grinding your teeth, dry mouth 
• Loss of appetite 
 
Uncommon side effects (may affect up to 1 in 100 people) 
• Feeling agitated, restlessness, inability to concentrate, shaking (tremors) 
• Increase in heart rate much higher than normal 
• Shortness of breath 
• Chest pain 
• Thirst 
• Weight loss. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed  
in Appendix V. By reporting side effects, you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Sunosi 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the bottle / blister after 
“EXP”. The expiry date refers to the last day of that month.  
 
Blisters: This medicine does not require any special storage conditions. 
 
Bottles: Once opened, use within 4 months. Keep the container tightly closed in order to protect from 
moisture. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other 
information  
 
What Sunosi contains 
The active substance is solriamfetol. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


39 

 
Sunosi 75 mg film-coated tablets 
Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol. 
 
Sunosi 150 mg film-coated tablets 
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol. 
 
The other ingredients are: 
Tablet cores: Hydroxypropyl cellulose, magnesium stearate 
 
Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172). 
 
What Sunosi looks like and contents of the pack 
 
Film-coated tablet 
 
Sunosi 75 mg film-coated tablets 
Yellow to dark yellow/orange oblong tablet with “75” debossed on one side and a score line on the 
opposite side. The tablet can be divided into equal doses. 
 
Sunosi 150 mg film-coated tablets  
Yellow oblong tablet with “150” debossed on one side. 
 
Sunosi is available in blister packs of 7, 28 and 56 film-coated tablets and in bottles of 30 and 100 
film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder and Manufacturer 
Jazz Pharmaceuticals Ireland Ltd  
5

th 
Floor 

Waterloo Exchange 
Waterloo Road Dublin 
D04 E5W7 
Ireland 
Tel: +44 8450305089 
Email: medinfo-int@jazzpharma.com 
 
 
This leaflet was last revised in .  
 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site:  
http://www.ema.europa.eu. 

mailto:medinfo-int@jazzpharma.com
http://www.ema.europa.eu/

	ANNEX I
	SUMMARY OF PRODUCT CHARACTERISTICS
	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
	3. PHARMACEUTICAL FORM
	4. CLINICAL PARTICULARS
	4.2 Posology and method of administration
	4.3 Contraindications
	4.4 Special warnings and precautions for use
	4.5 Interaction with other medicinal products and other forms of interaction
	4.6 Fertility, pregnancy and lactation
	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	Summary of the safety profile
	4.9 Overdose
	5. PHARMACOLOGICAL PROPERTIES
	Table 1. Overview of Efficacy Results at Week 12 in Patients with Narcolepsy in Study 1
	Figure 1: Co-Primary Efficacy Endpoints in Patients with Narcolepsy in Study 1
	Table 2. Overview of Efficacy Results at Week 12 in Patients with OSA in Study 2
	Figure 2: Co-Primary Efficacy Endpoints in Patients with OSA in Study 2
	5.2 Pharmacokinetic properties
	5.3 Preclinical safety data
	6. PHARMACEUTICAL PARTICULARS
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal
	7. MARKETING AUTHORISATION HOLDER
	8. MARKETING AUTHORISATION NUMBER(S)

	Name and address of the manufacturer(s) responsible for batch release
	ANNEX III

	A. LABELLING
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4.  PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	1. NAME OF THE MEDICINAL PRODUCT
	2. NAME OF THE MARKETING AUTHORISATION HOLDER
	3. EXPIRY DATE
	4. BATCH NUMBER
	5. OTHER
	PARTICULARS TO APPEAR ON THE OUTER PACKAGING
	CARTON - PACK OF 7, 28 and 56 TABLETS 150 mg STRENGTH
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
	BLISTERS - 150 mg STRENGTH
	1. NAME OF THE MEDICINAL PRODUCT
	2. NAME OF THE MARKETING AUTHORISATION HOLDER
	3. EXPIRY DATE
	4. BATCH NUMBER
	5. OTHER
	PARTICULARS TO APPEAR ON THE OUTER PACKAGING
	CARTON - PACK OF 30 and 100 TABLETS 75 mg STRENGTH
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
	BOTTLES - 75 mg STRENGTH
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	1. NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
	OF THE SIGHT AND REACH OF CHILDREN
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
	BOTTLES -150 mg STRENGTH
	1. NAME OF THE MEDICINAL PRODUCT
	2. . STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	16. INFORMATION IN BRAILLE
	17. UNIQUE IDENTIFIER – 2D BARCODE
	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
	B.  PACKAGE LEAFLET
	This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
	What is in this leaflet
	1. What Sunosi is and what it is used for
	2. What you need to know before you take Sunosi
	Do not take Sunosi if you:
	Warnings and precautions
	Children and adolescents
	Other medicines and Sunosi
	Pregnancy and breast-feeding
	Driving and using machines
	You may feel dizzy or your ability to concentrate may be impaired, take special care when driving or using machines.
	3. How to take Sunosi
	How much Sunosi to take
	Your doctor will advise you on the dose of Sunosi to take.
	Elderly (aged more than 65 years)
	Patients with kidney problems
	Taking Sunosi
	How long to take Sunosi
	If you take more Sunosi than you should
	If you forget to take Sunosi
	If you stop taking Sunosi
	4. Possible side effects
	Like all medicines, this medicine can cause side effects, although not everybody gets them.
	Very common side effects (may affect more than 1 in 10 people)
	Common side effects (may affect up to 1 in 10 people)
	 Loss of appetite
	Uncommon side effects (may affect up to 1 in 100 people)
	Reporting of side effects
	5. How to store Sunosi
	Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
	6. Contents of the pack and other information
	What Sunosi contains
	What Sunosi looks like and contents of the pack
	Marketing Authorisation Holder and Manufacturer
	This leaflet was last revised in .
	Other sources of information