Table 3.
Pitolisant Adverse Reactionsa50
| Adverse Effect | Pitolisant (%) (n = 152) |
Placebo (%) (n = 114) |
Includes the Following Terms: |
|---|---|---|---|
| Headache | 18 | 15 | Migraine, premenstrual, cluster, tension |
| Insomnia | 6 | 2 | Initial, middle insomnia, poor quality sleep |
| Nausea | 6 | 3 | |
| Upper Respiratory Infection | 5 | 3 | Pharyngitis, rhinitis, sinusitis, inflammation, viral |
| Musculoskeletal Pain | 5 | 3 | arthralgia, back pain, carpal tunnel Syndrome, limb discomfort, myalgia, neck pain, osteoarthritis, pain in extremity, sciatica |
| Anxiety | 5 | 1 | Nervousness, stress, stress at work |
| Increased Heart Rate | 3 | 0 | Sinus tachycardia, tachycardia |
| Hallucinations | 3 | 0 | Visual, hypnagogic |
| Irritability | 3 | 2 | |
| Abdominal Pain | 3 | 1 | Abdominal discomfort, upper abdominal pain |
| Sleep Disturbance | 3 | 2 | Dyssomnia, sleep disorder, sleep paralysis, sleep talking |
| Decreased Appetite | 3 | 0 | |
| Cataplexy | 2 | 1 | |
| Dry Mouth | 2 | 1 | |
| Rash | 2 | 1 | Eczema, erythema migrans, rash, urticaria |
Note: aAdverse reaction that occur in ≥ 2% of patients from three pooled randomized, placebo-controlled narcolepsy studies.