Bupropion

Evidence Level: L1

Predicted Indications: 10

Bupropion

Pharmacist Assessment Report

Bupropion: norepinephrine-dopamine reuptake inhibitor → attention deficit-hyperactivity disorder

One-Sentence Summary

Bupropion is an antidepressant that inhibits the reuptake of norepinephrine and dopamine. The TxGNN model predicts it may be effective for attention deficit-hyperactivity disorder, and the data compiled for this report include 6 clinical trials (4 of them completed with a direct ADHD focus) and 20 publications, including a Cochrane review of bupropion in adult ADHD.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	attention deficit-hyperactivity disorder
TxGNN Prediction Score	0.9999
Evidence Level	L1
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed mechanism-of-action data are not available in the compiled data. From the literature, bupropion’s main action is believed to be inhibition of dopamine and norepinephrine reuptake, and it has no serotonergic activity.

Established ADHD treatments, such as stimulants and atomoxetine, act on these same catecholamine pathways. Reduced dopamine and norepinephrine signalling is thought to underlie the inattention and hyperactivity of ADHD, so a drug that raises synaptic levels of both is mechanistically plausible. Several reviews in the evidence list bupropion among the non-stimulant options for adults who do not respond to, or cannot tolerate, stimulants.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00048360	Phase 3	Completed	162	8-week randomized, double-blind, placebo-controlled flexible-dose study of extended-release bupropion (300–450 mg/day) in adults with ADHD
NCT00936299	Phase 4	Completed	105	Bupropion for ADHD in adolescents with substance use disorder
NCT00061087	Phase 2/3	Completed	115	Treatment of adult ADHD in methadone-maintained patients
NCT01270555	Not applicable	Completed	32	Open study of bupropion SR in adults with ADHD and recent or current substance use disorders
NCT00000268	Not applicable	Completed	32	Cocaine abuse and attention deficit disorder; small study
NCT04553263	Early Phase 1	Withdrawn	0	Relapse prevention in stimulant use disorder with and without ADHD; no participants enrolled, so no data

Literature Evidence

PMID	Year	Type	Journal	Key Findings
28965364	2017	Cochrane review	Cochrane Database Syst Rev	Bupropion for ADHD in adults, as an alternative when stimulants are not tolerated or not effective
30097390	2018	Network meta-analysis	Lancet Psychiatry	Comparative efficacy and tolerability of ADHD medications across children, adolescents and adults
33085721	2020	Systematic review / network meta-analysis	PLoS One	Relative effects of pharmacologic treatments for adults with ADHD
40203844	2025	Network meta-analysis	Lancet Psychiatry	Comparative cardiovascular safety (haemodynamics and ECG) of ADHD medications
37405312	2023	Review	Health Psychol Res	Pharmacology of bupropion and its use in depression, ADHD and smoking cessation
38915262	2024	Review	Expert Rev Neurother	Non-stimulant medications for adults with ADHD
39172673	2024	Review	Am Fam Physician	Overview of ADHD diagnosis and management in adults
26601963	2016	Review	Curr Pharm Des	Effects and side effects of ADHD drugs; bupropion is listed among the medications used

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
25995	Bupron XL 300 Tablet	Tablet (extended release)	Not recorded
3894	Amfeta 150 Tablet ER	Tablet ER	Not recorded
31914	Bupdep 150mg Tablet SR	Tablet SR	Not recorded
27796	Brunojoy 150 Tablet ER	Tablet ER	Not recorded
247337	Zyban 150mg Tablet SR	Tablet SR	Not recorded

The licence list is partial; there are at least 20 valid single-ingredient licences in total.

Safety Considerations

Drug Interactions: 665 interactions are recorded. Major-level interactions include fentanyl, lidocaine, codeine, dihydrocodeine, tramadol, methylphenidate, hydrocortisone, aldesleukin, alfentanil and amantadine. Moderate-level interactions include ethanol, nifedipine, alprazolam, cetirizine and hydrochlorothiazide. Bupropion inhibits CYP2D6, which contributes to the interaction burden.
Conditions flagged for caution or contraindication in the compiled data: epilepsy, hypertension, liver disease and cirrhosis, kidney disease, bipolar mania, psychotic disorders, anorexia and bulimia nervosa, substance dependence (including opiate dependence), recent myocardial infarction, and central nervous system neoplasm.
Other points to watch: seizure risk is dose-dependent, blood pressure should be monitored, and caution is needed in patients with substance use comorbidity.

Package insert warnings and contraindications were not available; please refer to the package insert for full safety information.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: A completed Phase 3 placebo-controlled trial, a Phase 2/3 trial and a Phase 4 trial directly study bupropion in ADHD, and a Cochrane review addresses its use in adults. The Phase 3 trial’s comparator and arms should be checked, and the seizure, blood pressure and interaction risks call for guardrails.

To proceed, the following is needed:

Package insert warnings and contraindications from the local regulator
Detailed mechanism of action data
Verification of the Phase 3 trial’s design, results and dose arms
A monitoring plan for seizure risk, blood pressure and substance use comorbidity
A medication review to manage the large number of drug interactions, especially CYP2D6-metabolized drugs
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.