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 open-label extension study of adults and adolescents.2

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)
Headache08 (3.8%)13 (5.1%)10 (3.8%)12 (15.1%)4 (2.5%)5 (7.9%)
Insomnia2 (1.5%)4 (1.9%)9 (3.5%)9 (3.4%)14 (5.9%)7 (4.3%)3 (4.8%)
Decreased appetite3 (2.3%)5 (2.4%)9 (3.5%)11 (4.2%)14 (5.9%)1 (0.6%)1 (1.6%)
Initial Insomnia03 (1.4%)4 (1.6%)5 (1.9%)9 (3.8%)9 (5.5%)5 (7.9%)
Upper respiratory tract infection01 (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*If 25 mg/day was not tolerable, the patient was withdrawn.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 mg35 mg45 mg55 mg70 mg85 mg100 mg
Total n exposed13020825726223716363
Insomniaa2 (1.5%)6 (2.9%)15 (5.8%)14 (5.3%)26 (11.0%)16 (9.8%)10 (15.9%)
Sleep disorderb01 (0.5%)1 (0.4%)03 (1.3%)00
Somnolencec2 (1.5%)01 (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.”