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Strattera (ATOMOXETINE)
Strattera works by blocking the reabsorption of norepinephrine in the brain, allowing more of this neurotransmitter to be available for use.
Strattera (atomoxetine) is a small molecule norepinephrine reuptake inhibitor developed by Lilly, targeting the sodium-dependent noradrenaline transporter. It is FDA-approved since 2002 for the treatment of attention deficit hyperactivity disorder (ADHD). Strattera is now off-patent with multiple generic manufacturers. Key safety considerations include potential cardiovascular effects and increased risk of suicidal thoughts in children and adolescents. As a norepinephrine reuptake inhibitor, Strattera increases the levels of norepinephrine in the brain, which helps to improve focus and attention in individuals with ADHD.
At a glance
| Generic name | ATOMOXETINE |
|---|---|
| Sponsor | Eli Lilly |
| Drug class | Norepinephrine Reuptake Inhibitor |
| Target | Sodium-dependent noradrenaline transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2002 |
Mechanism of action
The precise mechanism by which atomoxetine producesits therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD)is unknown, but is thought to be related to selective inhibition of the pre-synapticnorepinephrine transporter, as determined in ex vivo uptakeand neurotransmitter depletion studies.
Approved indications
- Attention deficit hyperactivity disorder
Boxed warnings
- WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions ( 5.1 )]. WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS See full prescribing information for complete boxed warning. • Increased risk of suicidal ideation in children or adolescents (5.1) • No suicides occurred in clinical trials (5.1) • Patients started on therapy should be monitored closely (5.1)
Common side effects
- Nausea
- Vomiting
- Fatigue
- Decreased appetite
- Abdominal pain
- Somnolence
- Constipation
- Dry mouth
- Insomnia
- Erectile dysfunction
- Urinary hesitation
- Urinary retention
Drug interactions
- bupropion
- cinacalcet
- fluoxetine
- fosamprenavir
- isocarboxazid
- linezolid
- paroxetine
- phenelzine
- quinidine
- selegiline
- terbinafine
- tranylcypromine
Key clinical trials
- Atomoxetine and DAW2022 on OSA Severity (PHASE1,PHASE2)
- Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach (PHASE3)
- Atomoxetine and Executive Function in PTSD (PHASE4)
- TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease (EARLY_PHASE1)
- A Novel Pharmacological Therapy for Obstructive Sleep Apnea (PHASE2)
- Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea (PHASE1,PHASE2)
- Endotype DIrected Treatment for OSA in Down Syndrome (PHASE4)
- Pharmacological Agents for Chronic Spinal Cord Injury (SCI) (PHASE1)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |