Table 3.
Signal strength of AE reports related with solriamfetol at the Preferred Term (PT) level in FAERS database(∗: The instruction does not mention).
| SOC | Preferred Terms (PTs) | Solriamfetol Cases Reporting PT |
ROR(95 % two-sided CI) | PRR (χ2) | IC(IC025) | EBGM(EBGM05) |
|---|---|---|---|---|---|---|
| Nervous system disorders | Headache | 151 | 4.66 (3.96–5.49) | 4.51 (415.88) | 2.17 (1.85) | 4.51 (3.83) |
| Psychiatric disorders | Anxiety | 129 | 8.48 (7.11–10.11) | 8.21 (819.45) | 3.04 (2.55) | 8.20 (6.88) |
| Investigations | Blood pressure increased | 62 | 6.96 (5.41–8.95) | 6.86 (310.67) | 2.78 (2.16) | 6.85 (5.33) |
| Psychiatric disorders | Depression | 57 | 5.44 (4.19–7.07) | 5.37 (203.32) | 2.42 (1.87) | 5.37 (4.13) |
| Suicidal ideation | 48 | 11.91 (8.96–15.84) | 11.77 (472.54) | 3.55 (2.67) | 11.75 (8.83) | |
| Cardiac disorders | Palpitations | 40 | 6.96 (5.10–9.51) | 6.90 (201.81) | 2.78 (2.04) | 6.89 (5.05) |
| General disorders and administration site conditions | Feeling abnormal | 40 | 3.18 (2.33–4.35) | 3.16 (59.22) | 1.66 (1.21) | 3.16 (2.31) |
| Psychiatric disorders | Insomnia | 38 | 2.99 (2.17–4.11) | 2.96 (49.62) | 1.57 (1.14) | 2.96 (2.15) |
| Nervous system disorders | Somnolence | 35 | 3.34 (2.39–4.66) | 3.32 (56.74) | 1.73 (1.24) | 3.31 (2.38) |
| Investigations | Heart rate increased | 34 | 6.51 (4.64–9.13) | 6.46 (156.89) | 2.69 (1.92) | 6.45 (4.60) |
| Nervous system disorders | Migraine | 33 | 5.89 (4.18–8.30) | 5.85 (132.69) | 2.55 (1.81) | 5.84 (4.15) |
| Skin and subcutaneous tissue disorders | Hyperhidrosis | 31 | 5.03 (3.53–7.16) | 5.00 (99.16) | 2.32 (1.63) | 4.99 (3.51) |
| General disorders and administration site conditions | Feeling jittery | 28 | 37.24 (25.65–54.08) | 36.96 (974.18) | 5.20 (3.58) | 36.75 (25.31) |
| Nervous system disorders | Tremor | 27 | 3.42 (2.34–4.99) | 3.40 (45.77) | 1.76 (1.21) | 3.40 (2.33) |
| Cardiac disorders | Tachycardia | 25 | 5.32 (3.59–7.88) | 5.29 (86.91) | 2.40 (1.62) | 5.28 (3.56) |
| Psychiatric disorders | Irritability | 23 | 9.86 (6.54–14.87) | 9.81 (181.75) | 3.29 (2.18) | 9.79 (6.50) |
| Respiratory, thoracic and mediastinal disorders | Sleep apnoea syndrome | 23 | 19.91 (13.20–30.01) | 19.79 (409.08) | 4.30 (2.85) | 19.73 (13.08) |
| Gastrointestinal disorders | Dry mouth | 19 | 4.91 (3.12–7.70) | 4.88 (58.72) | 2.29 (1.46) | 4.88 (3.11) |
| Surgical and medical procedures | Surgery | 18 | 5.50 (3.46–8.75) | 5.48 (65.95) | 2.45 (1.54) | 5.48 (3.45) |
| Nervous system disorders | Disturbance in attention | 17 | 6.41 (3.98–10.32) | 6.38 (77.12) | 2.67 (1.66) | 6.38 (3.96) |
| Psychiatric disorders | Agitation | 16 | 5.30 (3.24–8.66) | 5.28 (55.47) | 2.40 (1.47) | 5.27 (3.23) |
| Panic attack | 10 | 5.87 (3.15–10.92) | 5.85 (40.22) | 2.55 (1.37) | 5.85 (3.14) | |
| Nervous system disorders | Hypersomnia | 9 | 5.82 (3.02–11.20) | 5.81 (35.79) | 2.54 (1.32) | 5.80 (3.02) |
| Pregnancy, puerperium and perinatal conditions | Abortion spontaneous∗ | 9 | 4.55 (2.36–8.75) | 4.54 (24.81) | 2.18 (1.13) | 4.53 (2.36) |
| Psychiatric disorders | Anger | 9 | 6.27 (3.26–12.06) | 6.25 (39.69) | 2.64 (1.37) | 6.25 (3.25) |
| Persecutory delusion | 9 | 71.49 (37.03–138.02) | 71.32 (616.97) | 6.14 (3.18) | 70.52 (36.53) | |
| Somnambulism∗ | 8 | 31.80 (15.87–63.76) | 31.74 (236.96) | 4.98 (2.48) | 31.58 (15.75) | |
| Nervous system disorders | Restless legs syndrome∗ | 7 | 7.42 (3.53–15.59) | 7.41 (38.78) | 2.89 (1.38) | 7.40 (3.52) |
| Psychiatric disorders | Thinking abnormal | 7 | 8.42 (4.01–17.68) | 8.40 (45.60) | 3.07 (1.46) | 8.39 (4.00) |
| Hepatobiliary disorders | Hepatic cytolysis | 6 | 6.68 (3.00–14.88) | 6.67 (28.88) | 2.74 (1.23) | 6.66 (2.99) |
| Psychiatric disorders | Post-traumatic stress disorder∗ | 6 | 12.34 (5.53–27.50) | 12.32 (62.28) | 3.62 (1.62) | 12.30 (5.52) |
| Vascular disorders | Raynaud's phenomenon∗ | 6 | 22.33 (10.01–49.80) | 22.29 (121.60) | 4.47 (2.01) | 22.22 (9.96) |
| Metabolism and nutrition disorders | Obesity∗ | 5 | 6.37 (2.65–15.32) | 6.36 (22.58) | 2.67 (1.11) | 6.36 (2.64) |
| Nervous system disorders | Carpal tunnel syndrome∗ | 5 | 6.30 (2.62–15.15) | 6.29 (22.23) | 2.65 (1.10) | 6.29 (2.61) |
| Cataplexy | 5 | 80.88 (33.46–195.54) | 80.77 (388.91) | 6.32 (2.61) | 79.76 (32.99) | |
| Psychiatric disorders | Abnormal dreams∗ | 5 | 5.96 (2.48–14.33) | 5.95 (20.59) | 2.57 (1.07) | 5.95 (2.47) |
| Paranoia | 5 | 7.01 (2.92–16.87) | 7.01 (25.72) | 2.81 (1.17) | 7.00 (2.91) | |
| Social circumstances | Impaired driving ability∗ | 5 | 11.84 (4.92–28.48) | 11.82 (49.44) | 3.56 (1.48) | 11.80 (4.90) |
| Metabolism and nutrition disorders | Vitamin D deficiency∗ | 4 | 7.27 (2.72–19.39) | 7.26 (21.57) | 2.86 (1.07) | 7.25 (2.72) |
| Nervous system disorders | Psychomotor hyperactivity | 4 | 5.55 (2.08–14.81) | 5.55 (14.90) | 2.47 (0.93) | 5.54 (2.08) |
| Tardive dyskinesia | 4 | 6.34 (2.38–16.91) | 6.33 (17.95) | 2.66 (1.00) | 6.33 (2.37) | |
| Psychiatric disorders | Libido decreased | 4 | 8.13 (3.05–21.70) | 8.13 (24.97) | 3.02 (1.13) | 8.12 (3.04) |
| Bipolar disorder | 4 | 8.32 (3.12–22.18) | 8.31 (25.68) | 3.05 (1.14) | 8.30 (3.11) | |
| Mania | 4 | 6.08 (2.28–16.21) | 6.07 (16.94) | 2.60 (0.98) | 6.07 (2.28) | |
| Initial insomnia | 4 | 8.71 (3.27–23.24) | 8.70 (27.23) | 3.12 (1.17) | 8.69 (3.26) | |
| Sleep attacks | 4 | 302.40 (110.82–825.19) | 302.06 (1145.09) | 8.17 (2.99) | 288.22 (105.62) | |
| Major depression | 4 | 10.24 (3.84–27.31) | 10.22 (33.24) | 3.35 (1.26) | 10.21 (3.83) | |
| Respiratory, thoracic and mediastinal disorders | Asthma exercise induced∗ | 4 | 181.88 (67.27–491.75) | 181.68 (698.49) | 7.46 (2.76) | 176.59 (65.31) |
| Gastrointestinal disorders | Impaired gastric emptying∗ | 3 | 6.54 (2.11–20.29) | 6.53 (14.05) | 2.71 (0.87) | 6.53 (2.10) |
| Lip dry | 3 | 7.94 (2.56–24.65) | 7.93 (18.16) | 2.99 (0.96) | 7.93 (2.55) | |
| General disorders and administration site conditions | Feeling of body temperature change∗ | 3 | 10.39 (3.34–32.25) | 10.38 (25.38) | 3.37 (1.09) | 10.36 (3.34) |
| Tachyphylaxis | 3 | 163.64 (51.99–515.14) | 163.51 (472.23) | 7.32 (2.32) | 159.38 (50.63) | |
| Feeling drunk | 3 | 10.13 (3.26–31.46) | 10.13 (24.64) | 3.34 (1.08) | 10.11 (3.26) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Uterine leiomyoma∗ | 3 | 9.84 (3.17–30.56) | 9.83 (23.77) | 3.30 (1.06) | 9.82 (3.16) |
| Psychiatric disorders | Parasomnia | 3 | 94.10 (30.08–294.37) | 94.02 (272.01) | 6.53 (2.09) | 92.64 (29.61) |
| Renal and urinary disorders | Hemorrhage urinary tract∗ | 3 | 21.22 (6.83–65.94) | 21.20 (57.55) | 4.40 (1.42) | 21.13 (6.80) |
| Reproductive system and breast disorders | Endometriosis∗ | 3 | 11.82 (3.81–36.71) | 11.81 (29.63) | 3.56 (1.15) | 11.79 (3.80) |
| Respiratory, thoracic and mediastinal disorders | Throat clearing | 3 | 6.85 (2.21–21.25) | 6.84 (14.94) | 2.77 (0.89) | 6.83 (2.20) |
| Surgical and medical procedures | Cholecystectomy | 3 | 6.42 (2.07–19.93) | 6.42 (13.71) | 2.68 (0.86) | 6.41 (2.07) |
ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; χ2, chi-information component; IC, information component; IC025, the lower limit of 95 % CI of the IC; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of 95 % CI of EBGM.