Sunosi

Last updated on RxList: 10/17/2019
Sunosi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/17/2019

Sunosi (solriamfetol) 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). Common side effects of Sunosi include:

Sunosi is administered once daily upon awakening. The starting dose of Sunosi for patients with narcolepsy is 75 mg once daily. The starting dose of Sunosi for patients with OSA is 37.5 mg once daily. Sunosi may interact with monoamine oxidase inhibitors (MAOIs), other drugs that increase blood pressure and/or heart rate, and dopaminergic drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Sunosi; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Sunosi during pregnancy. It is unknown if Sunosi passes into breast milk. Consult your doctor before breastfeeding.

Our Sunosi (solriamfetol) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow
Sunosi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • racing thoughts, increased energy, decreased need for sleep, feeling agitated or irritable;
  • ongoing sleep problems;
  • fast or pounding heartbeats; or
  • severe headache, blurred vision, pounding in your neck or ears.

Common side effects may include:

  • trouble sleeping;
  • anxiety;
  • nausea, loss of appetite; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sunosi (Solriamfetol Tablets)

QUESTION

Why do we sleep? See Answer
Sunosi Professional Information

SIDE EFFECTS

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]
  • Psychiatric Symptoms [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebo-controlled trials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily. Information provided below is based on the pooled 12-week placebo-controlled studies in patients with narcolepsy or OSA.

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported more frequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populations were headache, nausea, decreased appetite, anxiety, and insomnia.

Table 1 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently in SUNOSI-treated patients than in placebo-treated patients in the narcolepsy population.

Table 1: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy (75 mg and 150 mg)

System Organ Class Narcolepsy
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 in SUNOSI-treated patients than in placebo-treated patients in the OSA population.

Table 2: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in OSA (37.5 mg, 75 mg, and 150 mg)

System Organ Class OSA
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
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 and vomiting. “Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominal discomfort.

Other Adverse Reactions Observed During The Premarketing Evaluation Of SUNOSI

Other 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 elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, or 4) which were not considered to have clinically significant implications.

Narcolepsy Population

Psychiatric disorders: agitation, bruxism, irritability

Respiratory, thoracic and mediastinal disorders: cough

Skin and subcutaneous tissue disorders: hyperhidrosis

General disorders and administration site conditions: feeling jittery, thirst, chest discomfort, chest pain

Investigations: weight decreased

OSA Population

Psychiatric disorders: bruxism, restlessness

Nervous system disorders: disturbances in attention, tremor

Respiratory, thoracic and mediastinal disorders: cough, dyspnea

Gastrointestinal disorders: constipation, vomiting

Investigations: weight decreased

Dose-Dependent Adverse Reactions

In 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 and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy and OSA

  Placebo
N = 226 (%)
SUNOSI 37.5 mg
N = 58* (%)
SUNOSI 75 mg
N = 120 (%)
SUNOSI 150 mg
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 received SUNOSI 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 more than 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 shows maximum mean changes in blood pressure and heart rate recorded at sessions where the Maintenance of Wakefulness Test (MWT) was administered [see Clinical Studies]. Table 5 summarizes 24-hour ambulatory blood pressure monitoring (ABPM) and ambulatory heart rate monitoring performed in the outpatient setting.

Table 4: Maximal Mean Changes in Blood Pressure and Heart Rate Assessed at MWT Sessions from Baseline through Week 12: Mean (95% CI)*

    Placebo SUNOSI 37.5 mg SUNOSI 75 mg SUNOSI 150 mg SUNOSI 300 mg**
Narcolepsy STUDY 1 n 52 - 51 49 53
SBP 3.5
(0.7, 6.4)
- 3.1
(0.1, 6.0)
4.9
(1.7, 8.2)
6.8
(3.2, 10.3)
n 23 - 47 49 53
DBP 1.8
(-1.8, 5.5)
- 2.2
(0.2, 4.1)
4.2
(2.0, 6.5)
4.2
(1.5, 6.9)
n 48 - 26 49 53
HR 2.3
(-0.1, 4.7)
- 3.7
(0.4, 6.9)
4.9
(2.3, 7.6)
6.5
(3.9, 9.0)
OSA STUDY 2 n 35 17 54 103 35
SBP 1.7
(-1.4, 4.9)
4.6
(-1.1, 10.2)
3.8
(1.2, 6.4)
2.4
(0.4, 4.4)
4.5
(1.1, 7.9)
n 99 17 17 107 91
DBP 1.4
(-0.1, 2.9)
1.9
(-2.3, 6.0)
3.2
(-0.9, 7.3)
1.8
(0.4, 3.2)
3.3
(1.8, 4.8)
n 106 17 51 102 91
HR 1.7
(0.1, 3.3)
1.9
(-1.9, 5.7)
3.3
(0.6, 6.0)
2.9
(1.4, 4.4)
4.5
(3.0, 6.0)
SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate
* For study weeks 1, 4, and 12, SBP, DBP, and HR were assessed pre-dose and every 1-2 hours for 10 hours after test drug administration. For all time points at all visits, the mean change from baseline was calculated, by indication and dose, for all patients with a valid assessment. The table shows, by indication and dose, the mean changes from baseline for the week and time point with the maximal change in SBP, DBP, and HR.
** The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Table 5: Blood Pressure and Heart Rate by 24-hour Ambulatory Monitoring: Mean Change (95% CI) from Baseline at Week 8

    Placebo SUNOSI 37.5 mg SUNOSI 75 mg SUNOSI 150 mg SUNOSI 300 mg**
Narcolepsy STUDY 1 n* 46 44 44 40
SBP -0.4
(-3.1, 2.4)
- 1.6
(-0.4, 3.5)
-0.5
(-2.1, 1.1)
2.4
(0.5, 4.3)
DBP -0.2
(-1.9, 1.6)
- 1.0
(-0.4, 2.5)
0.8
(-0.4, 2.0)
3.0
(1.4, 4.5)
HR 0.0
(-1.9, 2.0)
- 0.2
(-2.1, 2.4)
1.0
(-1.2, 3.2)
4.8
(2.3, 7.2)
OSA STUDY 2 n* 92 43 49 96 84
SBP -0.2
(-1.8, 1.4)
1.8
(-1.1, 4.6)
2.6
(0.02, 5.3)
-0.2
(-2.0, 1.6)
2.8
(-0.1, 5.8)
DBP 0.2
(-0.9, 1.3)
1.4
(-0.4, 3.2)
1.5
(-0.04, 3.1)
-0.1
(-1.1, 1.0)
2.4
(0.5, 4.4)
HR -0.4
(-1.7, 0.9)
0.4
(-1.4, 2.2)
1.0
(-0.9, 2.81)
1.7
(0.5, 2.9)
1.6
(0.3, 2.9)
SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate
* Number of patients who had at least 50% valid ABPM readings.
** The maximum recommended daily dose is 150 mg. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Read the entire FDA prescribing information for Sunosi (Solriamfetol Tablets)

© Sunosi Patient Information is supplied by Cerner Multum, Inc. and Sunosi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors