What the label lists and what reports show
Solriamfetol side effects
Solriamfetol's FDA label: “Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety.” FAERS holds 3,777 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anxiety (335 reports).
- No generic listed
- DEA Schedule IV
Check it at the source: the solriamfetol FDA label on DailyMed (effective May 5, 2026, Axsome Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SUNOSI?SUNOSI may cause serious side effects, including: Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure and death. Your healthcare provider should check your blood pressure before you start and during treatment with SUNOSI. Your healthcare provider may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI. Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability and agitation. Tell your healthcare provider if you develop anxiety, problems sleeping, irritability, agitation. Your healthcare provider may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI. […]
Source: FDA drug label, Axsome Therapeutics, Inc., effective May 5, 2026 (SPL set 362f206b-73e7-4009-8c34-5a9df55679ab), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety.
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
| Reaction | 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics, Inc. at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. …
Source: FDA drug label, Axsome Therapeutics, Inc., effective May 5, 2026 (SPL set 362f206b-73e7-4009-8c34-5a9df55679ab), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,777 reports list solriamfetol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 329 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Solriamfetol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions