TABLE 4.
Treatment discontinuation and individual adverse events for suvorexant vs. placebo.
| Adverse events | N | No. of cases (suvorexant/placebo) | RR | 95% CI | P-value | I2, % |
| Discontinuation due to all cause* | 7 | 1,978/1,218 | 0.95 | 0.82, 1.10 | 0.48 | 0 |
| Discontinuation due to intolerability* | 7 | 1,978/1,218 | 1.00 | 0.74, 1.35 | 1.00 | 29 |
| Discontinuation due to inefficacy* | 7 | 1,978/1,218 | 0.75 | 0.52, 1.09 | 0.13 | 0 |
| ≥1 adverse event | 7 | 1,986/1,228 | 1.07 | 0.99, 1.15 | 0.07 | 0 |
| ≥1 drug-related adverse event** | 7 | 1,986/1,228 | 1.62 | 1.40, 1.89 | <0.00001 | 10 |
| ≥1 serious adverse event | 7 | 1,986/1,228 | 0.70 | 0.27, 1.84 | 0.47 | 52 |
| Discontinued owing to adverse event | 3 | 723/461 | 1.37 | 0.88, 2.13 | 0.16 | 0 |
| Somnolence | 7 | 1,986/1,228 | 3.26 | 2.29, 4.63 | <0.00001 | 0 |
| Excessive daytime sleepiness/sedation*** | 5 | 1,784/1,025 | 3.48 | 1.13, 10.67 | 0.03 | 0 |
| Fatigue | 6 | 1,844/1,085 | 2.09 | 1.28, 3.43 | 0.003 | 3 |
| Cataplexy | 6 | 1,926/1,168 | Not estimable | – | − | – |
| Sleep paralysis | 6 | 1,926/1,168 | 2.84 | 0.49, 16.35 | 0.24 | 0 |
| Complex sleep–related behaviors | 6 | 1,926/1,168 | 1.66 | 0.17, 15.84 | 0.66 | 0 |
| Hypnagogic/hypnopompic hallucination | 6 | 1,926/1,168 | 3.12 | 0.67, 14.47 | 0.15 | 0 |
| Abnormal dreams | 4 | 1,263/767 | 2.91 | 1.12, 7.60 | 0.03 | 0 |
| Suicidal ideation/behavior | 6 | 1,926/1,168 | 1.91 | 0.46, 7.92 | 0.38 | 20 |
| Events indicative of abuse potential**** | 6 | 1,926/1,168 | 1.08 | 0.69, 1.68 | 0.74 | 0 |
| Fall# | 6 | 1,926/1,168 | 1.03 | 0.56, 1.89 | 0.92 | 19 |
| Headache | 7 | 1,986/1,228 | 1.13 | 0.86, 1.47 | 0.39 | 0 |
| Dizziness | 6 | 1,844/1,685 | 1.62 | 0.57, 4.57 | 0.36 | 85 |
| Back pain | 5 | 1,784/1,025 | 0.51 | 0.27, 0.97 | 0.04 | 0 |
| Dry mouth | 7 | 1,986/1,228 | 2.15 | 1.23, 3.76 | 0.008 | 0 |
| Nasopharyngitis | 5 | 1,784/1,025 | 0.95 | 0.71, 1.28 | 0.75 | 0 |
| Motor vehicle accidents/violations## | 5 | 1,660/963 | 1.21 | 0.72, 2.05 | 0.47 | 11 |
| Sleep-onset paralysis | 2 | 663/401 | 1.49 | 0.06, 36.41 | 0.81 | – |
| Weight: ≥7% increase at month 3 | 4 | 1,250/1,514 | 1.38 | 0.78, 2.45 | 0.26 | 0 |
| Weight: ≥7% decrease at month 3 | 4 | 1,250/1,514 | 1.85 | 0.84, 4.11 | 0.13 | 0 |
95% CI, 95% confidence interval; N, number of comparisons/studies; RR, risk ratio; weight: ≥7%, the mean changes from baseline in weight and proportions of patients with ≥ 7% increase or decrease in weight.
*The counts for discontinuations due to adverse events are based on the period in which the adverse event started.
**Drug-related adverse event a determined by the investigator to be related to the drug (determination made while blinded).
***Excessive daytime sleepiness was defined as a more persistent daytime sleepiness than typical next-day residual somnolence.
****Terms included depersonalization, derealization, dissociation, euphoric mood, mania, hallucination, and potential study medication misuse.
#Falls were adjudicated to determine whether they were suggestive of cataplexy.
##Includes spontaneously reported events when the patient was the driver and events elicited via a motor vehicle accidents and violations questionnaire.