Headache, insomnia, and decreased appetite were the most frequent TEAEs in an open-label extension study of adults and adolescents.2
Headache, insomnia, and decreased appetite were the most frequent TEAEs in an
ADULT & ADOLESCENT OPEN-LABEL EXTENSION STUDY
Six-month safety analysis in patients with ADHD2
Study design: A six-month, open-label, multicenter, phase 3 study that included 184 adult (≥18 years) and 176 adolescent (≥12 and <18 years) males and females with ADHD who completed the Adult or Adolescent Symptom Studies (same inclusion/exclusion criteria; patients diagnosed with an exclusionary criterion during the original studies were also excluded).
Initial doses were titrated to 25, 35, 45, 55, 70, 85, or 100 mg.
- Mean starting does=35 mg/day
- Maximum dose: adolescents=85 mg/day; adults=100 mg/day
Doses were administered once daily upon wakening and prior to leaving for work/school.*
Primary outcome: Safety, consisting of spontaneously reported adverse events.†
- Three TEAEs occurred in ≥10% of all subjects: headache (12.9%), insomnia (12.9%), and decreased appetite (11.3%)
- Seventeen patients discontinued due to TEAEs. The most common was insomnia (n=2)
MOST FREQUENT TEAEs BY DOSE (ALL ENROLLED SUBJECTS)
IN OPEN-LABEL EXTENSION STUDY2
| 25 mg (n=130) | 35 mg (n=208) | 45 mg (n=257) | 55 mg (n=262) | 70 mg (n=237) | 85 mg (n=163) | 100 mg (n=63) | |
|---|---|---|---|---|---|---|---|
| Headache | 0 | 8 (3.8%) | 13 (5.1%) | 10 (3.8%) | 12 (15.1%) | 4 (2.5%) | 5 (7.9%) |
| Insomnia | 2 (1.5%) | 4 (1.9%) | 9 (3.5%) | 9 (3.4%) | 14 (5.9%) | 7 (4.3%) | 3 (4.8%) |
| Decreased appetite | 3 (2.3%) | 5 (2.4%) | 9 (3.5%) | 11 (4.2%) | 14 (5.9%) | 1 (0.6%) | 1 (1.6%) |
| Initial Insomnia | 0 | 3 (1.4%) | 4 (1.6%) | 5 (1.9%) | 9 (3.8%) | 9 (5.5%) | 5 (7.9%) |
| Upper respiratory tract infection | 0 | 1 (0.5%) | 6 (2.3%) | 8 (3.1%) | 7 (3.0%) | 8 (4.9%) | 1 (1.6%) |
TEAEs=treatment-emergent adverse events.
*If 25 mg/day was not tolerable, the patient was withdrawn. Dosage could also be decreased due to side effects or physician discretion.2
†In this open-label, optimized-dose study, patients were titrated to a dose that adequately controlled their ADHD symptoms without significant, unwanted adverse events. While this closely mimics standard clinical practice and allows patients/clinicians to decide on the best dose, the study was not blinded, as all patients and clinician raters knew that patients were receiving active medication.2
Note: Drugs known to have clinically important interactions with Adhansia XR are monoamine oxidase inhibitors, gastric pH modulators, antihypertensive drugs, halogenated anesthetics, and risperidone.1
INSOMNIA RATES
FREQUENCY OF SLEEP-RELATED ADVERSE EVENTS BY DOSE IN OPEN-LABEL EXTENSION STUDY
(ADULTS AND ADOLESCENTS)2
SLEEP-RELATED AEs | DOSE OF ADHANSIA XR (mg/day) | ||||||
|---|---|---|---|---|---|---|---|
| 25 mg | 35 mg | 45 mg | 55 mg | 70 mg | 85 mg | 100 mg | |
| Total n exposed | 130 | 208 | 257 | 262 | 237 | 163 | 63 |
| Insomniaa | 2 (1.5%) | 6 (2.9%) | 15 (5.8%) | 14 (5.3%) | 26 (11.0%) | 16 (9.8%) | 10 (15.9%) |
| Sleep disorderb | 0 | 1 (0.5%) | 1 (0.4%) | 0 | 3 (1.3%) | 0 | 0 |
| Somnolencec | 2 (1.5%) | 0 | 1 (0.4%) | 3 (1.1%) | 1 (0.4%) | 1 (0.6%) | 0 |
Two patients discontinued treatment due to insomnia.2
AEs=adverse events.
aIncludes preferred terms “insomnia,” “initial insomnia,” “middle insomnia,” “terminal insomnia.”
blncludes preferred terms “sleep disorder,” “delayed sleep phase.”
clncludes preferred terms “somnolence,” “hypersomnia,” “lethargy.”