NEFAZODONE HYDROCHLORIDE
NEFAZODONE HYDROCHLORIDE is indicated for the treatment of Depression; Major Depressive Disorder.
How NEFAZODONE HYDROCHLORIDE Works
Nefazodone hydrochloride is a phenylpiperazine antidepressant that acts as a Serotonin Antagonist and Reuptake Inhibitor (SARI). Its primary mechanism of action involves potent antagonism of central 5-HT2A receptors and moderate inhibition of the neuronal reuptake of serotonin (5-HT) and norepinephrine. By blocking 5-HT2A receptors, nefazodone redirects serotonin to other receptor subtypes (like 5-HT1A), which is thought to contribute to its antidepressant and anxiolytic effects while minimizing common SSRI-related side effects such as insomnia, agitation, and sexual dysfunction. It also possesses antagonist activity at alpha-1 adrenergic receptors.
Details
- Status
- Discontinued
- First Approved
- 2003-09-16
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
NEFAZODONE HYDROCHLORIDE Approval History
What NEFAZODONE HYDROCHLORIDE Treats
2 indicationsNEFAZODONE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
- Major Depressive Disorder
NEFAZODONE HYDROCHLORIDE Boxed Warning
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nefazodone hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the...
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nefazodone hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nefazodone hydrochloride tablets are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk ; PRECAUTIONS, Information for Patients ; and PRECAUTIONS, Pediatric Use ).
NEFAZODONE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEFAZODONE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)NEFAZODONE HYDROCHLORIDE is indicated for the treatment of Depression; Major Depressive Disorder.
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use ...
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SERZONE
Full clinical data, patents, trials, and competitive landscape for nefazodone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.