Last reviewed · How we verify
CEP-10953 (Armodafinil)
Armodafinil promotes wakefulness by increasing dopamine levels in the brain, likely through dopamine reuptake inhibition and other monoaminergic pathways.
Armodafinil promotes wakefulness by increasing dopamine levels in the brain, likely through dopamine reuptake inhibition and other monoaminergic pathways. Used for Narcolepsy, Obstructive sleep apnea, Shift work sleep disorder.
At a glance
| Generic name | CEP-10953 (Armodafinil) |
|---|---|
| Sponsor | Cephalon |
| Drug class | Wakefulness-promoting agent |
| Target | Dopamine transporter (DAT) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | Phase 3 |
Mechanism of action
Armodafinil is the active R-enantiomer of modafinil, a wakefulness-promoting agent. It binds to and inhibits the dopamine transporter, increasing dopamine concentration in the nucleus accumbens and prefrontal cortex. The drug may also modulate other neurotransmitter systems including norepinephrine and histamine, contributing to its stimulant-like effects without the typical sympathomimetic profile of classical stimulants.
Approved indications
- Narcolepsy
- Obstructive sleep apnea
- Shift work sleep disorder
- Excessive daytime sleepiness
Common side effects
- Headache
- Nausea
- Insomnia
- Anxiety
- Dizziness
- Dry mouth
Key clinical trials
- Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury (PHASE3)
- Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy (PHASE1)
- Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (PHASE3)
- Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (PHASE3)
- Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (PHASE3)
- Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness (PHASE3)
- Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CEP-10953 (Armodafinil) CI brief — competitive landscape report
- CEP-10953 (Armodafinil) updates RSS · CI watch RSS
- Cephalon portfolio CI