Solriamfetol side effects: what 3,777 FDA adverse event reports show

Solriamfetol · Sunosi · 163 reaction terms · 6,426 drug–reaction co-reports · data 2026-09-14

Drug class

Dopamine and Norepinephrine Reuptake Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Sunosi

openFDA label

Who reports

3,777 reports · 42% serious · 14 with death outcome · 74% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA.

FDA label, Indications and Usage

What it is

SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name ( R )-2-amino-3-phenylpropylcarbamate hydrochloride.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 6Likely indication confounding 2Reporting / coding artifact 11Not in label — unassessed 21

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 123 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Nocturia (night-time urination)	66	30.4 23.9–38.7ROR 30.9 · χ² 1,839 / p <1e-300	30.0 EB05 24.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 37.0 · 73% consumer	no trial data cached
Initial insomnia	51	27.9 21.2–36.7ROR 28.3 · χ² 1,290 / p 8e-283	27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=11 · 86% consumer	no trial data cached
Intentional dose omission	132	26.9 22.8–31.8ROR 27.9 · χ² 3,257 / p <1e-300	26.7 EB05 23.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 58.2	no trial data cached
Sleep apnoea syndrome	89	25.9 21.1–31.9ROR 26.6 · χ² 2,102 / p <1e-300	25.7 EB05 21.5 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 33.4	no trial data cached
Drug effect less than expected	65	25.7 20.2–32.7ROR 26.1 · χ² 1,513 / p <1e-300	25.4 EB05 20.6 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious n=19	no trial data cached
Brain fog	65	24.8 19.5–31.6ROR 25.3 · χ² 1,458 / p <1e-300	24.6 EB05 20.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.5 · 75% consumer	no trial data cached
Middle insomnia	78	23.4 18.8–29.1ROR 23.8 · χ² 1,643 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.6 · 94% consumer	no trial data cached
Bipolar disorder	38	19.3 14.1–26.5ROR 19.5 · χ² 640 / p 1e-141	19.1 EB05 14.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 30.5	no trial data cached
Surgery	176	16.9 14.6–19.5ROR 17.7 · χ² 2,617 / p <1e-300	16.8 EB05 14.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 26.6	no trial data cached
Feeling jittery	55	16.0 12.3–20.9ROR 16.3 · χ² 759 / p 3e-167	15.9 EB05 12.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=22	no trial data cached
Poor quality sleep	40	10.4 7.6–14.2ROR 10.5 · χ² 330 / p 5e-74	9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.3 · 72% consumer	no trial data cached
Hunger	24	9.9 6.7–14.8ROR 10.0 · χ² 184 / p 4e-42	9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Restless legs syndrome	31	9.5 6.7–13.4ROR 9.5 · χ² 226 / p 2e-51	8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Paranoia	29	9.3 6.5–13.4ROR 9.4 · χ² 207 / p 4e-47	8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Panic attack	58	8.8 6.8–11.4ROR 9.0 · χ² 395 / p 3e-88	8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0	no trial data cached
Knee operation	15	8.6 5.2–14.2ROR 8.6 · χ² 93 / p 3e-22	7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 13.2	no trial data cached
Spinal operation	18	8.3 5.2–13.1ROR 8.3 · χ² 108 / p 2e-25	7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4	no trial data cached
Vitamin d deficiency	14	8.0 4.7–13.5ROR 8.0 · χ² 79 / p 4e-19	6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Insurance issue	21	7.9 5.1–12.0ROR 7.9 · χ² 119 / p 6e-28	6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · 100% consumer	no trial data cached
Suicidal ideation (thoughts of suicide)	121	7.3 6.2–8.7ROR 7.5 · χ² 658 / p 2e-145	7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Disability	26	7.3 5.0–10.7ROR 7.3 · χ² 135 / p 2e-31	6.6 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Hypersomnia	35	6.8 4.9–9.5ROR 6.8 · χ² 167 / p 1e-38	6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.3 · ♀ 97% (drug 74%) · 76% consumer	no trial data cached
Therapeutic response unexpected	55	6.8 5.2–8.8ROR 6.9 · χ² 266 / p 4e-60	6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 16.7	no trial data cached
Somnolence (drowsiness)	243	6.7 5.9–7.6ROR 7.1 · χ² 1,187 / p 2e-260	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Anxiety	335	6.5 5.9–7.2ROR 7.1 · χ² 1,582 / p <1e-300	6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3	no trial data cached
Cholecystectomy	13	6.4 3.7–10.9ROR 6.4 · χ² 53 / p 1e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Nephrolithiasis (kidney stones)	52	6.3 4.8–8.3ROR 6.4 · χ² 228 / p 9e-52	6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Prescribed overdose	22	6.3 4.2–9.6ROR 6.3 · χ² 93 / p 2e-22	5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Intentional product use issue	97	6.1 5.0–7.5ROR 6.3 · χ² 412 / p 5e-92	6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.9	no trial data cached
Migraine	98	5.7 4.7–7.0ROR 5.9 · χ² 380 / p 6e-85	5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Night sweats	33	5.7 4.1–8.0ROR 5.7 · χ² 123 / p 7e-29	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 78% consumer	no trial data cached
Thinking abnormal	19	5.6 3.6–8.8ROR 5.7 · χ² 68 / p 9e-17	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Therapeutic product effect decreased	45	5.6 4.2–7.5ROR 5.7 · χ² 167 / p 2e-38	5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 74% consumer	no trial data cached
Limb injury	26	5.3 3.6–7.8ROR 5.4 · χ² 87 / p 5e-21	4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.1 · 73% consumer	no trial data cached
Impaired gastric emptying	12	5.2 3.0–9.2ROR 5.2 · χ² 37 / p 6e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Therapeutic response shortened	29	5.1 3.5–7.3ROR 5.1 · χ² 91 / p 9e-22	4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0	no trial data cached
Obesity	14	4.9 2.9–8.2ROR 4.9 · χ² 39 / p 2e-10	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Blood pressure increased	134	4.9 4.1–5.7ROR 5.0 · χ² 409 / p 2e-91	4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.5	no trial data cached
Intervertebral disc protrusion	19	4.8 3.1–7.5ROR 4.8 · χ² 54 / p 1e-13	4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Illness	87	4.8 3.9–5.9ROR 4.9 · χ² 260 / p 9e-59	4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective (drug did not work)	539	2.3 2.1–2.5ROR 2.5 · χ² 409 / p 4e-91	2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.3	no trial data cached
Anxiety	335	6.5 5.9–7.2ROR 7.1 · χ² 1,582 / p <1e-300	6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3	no trial data cached
Headache	313	2.8 2.5–3.1ROR 2.9 · χ² 365 / p 1e-81	2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	no trial data cached
Somnolence (drowsiness)	243	6.7 5.9–7.6ROR 7.1 · χ² 1,187 / p 2e-260	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Product dose omission issue	194	3.8 3.3–4.3ROR 3.9 · χ² 400 / p 3e-89	3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 13.2	no trial data cached
Surgery	176	16.9 14.6–19.5ROR 17.7 · χ² 2,617 / p <1e-300	16.8 EB05 14.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 26.6	no trial data cached
Depression	166	4.0 3.5–4.7ROR 4.2 · χ² 380 / p 7e-85	4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Insomnia (trouble sleeping)	162	3.4 2.9–3.9ROR 3.5 · χ² 271 / p 3e-61	3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8	no trial data cached
Feeling abnormal	151	3.5 3.0–4.1ROR 3.6 · χ² 268 / p 1e-60	3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.5	no trial data cached
Blood pressure increased	134	4.9 4.1–5.7ROR 5.0 · χ² 409 / p 2e-91	4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.5	no trial data cached
Intentional dose omission	132	26.9 22.8–31.8ROR 27.9 · χ² 3,257 / p <1e-300	26.7 EB05 23.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 58.2	no trial data cached
Suicidal ideation (thoughts of suicide)	121	7.3 6.2–8.7ROR 7.5 · χ² 658 / p 2e-145	7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Tremor (shaking)	99	3.3 2.7–4.0ROR 3.4 · χ² 158 / p 1e-36	3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	no trial data cached
Migraine	98	5.7 4.7–7.0ROR 5.9 · χ² 380 / p 6e-85	5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Intentional product use issue	97	6.1 5.0–7.5ROR 6.3 · χ² 412 / p 5e-92	6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.9	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Nocturia — n=66, PRR 30.4
Brain fog — n=65, PRR 24.8
Hunger — n=24, PRR 9.9
Restless legs syndrome — n=31, PRR 9.5
Paranoia — n=29, PRR 9.3
Insurance issue — n=21, PRR 7.9
Suicidal ideation — n=121, PRR 7.3
Disability — n=26, PRR 7.3
Hypersomnia — n=35, PRR 6.8
Somnolence — n=243, PRR 6.7

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Solriamfetol?

In FDA FAERS, the most frequently co-reported reaction terms for Solriamfetol are anxiety, headache, somnolence, depression, insomnia, feeling abnormal. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Solriamfetol have an FDA boxed warning?

No. The FDA label retrieved for Solriamfetol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Solriamfetol causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 362f206b-73e7-4009-8c34-5a9df55679ab, effective 20260505; matched on openfda.generic_name.exact:"SOLRIAMFETOL")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 163 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.