IMIPRAMINE HYDROCHLORIDE
Imipramine hydrochloride is a tricyclic antidepressant indicated for the relief of depressive symptoms, specifically endogenous depression, with therapeutic effects typically manifesting within one to three weeks. It is also indicated as a temporary adjunctive therapy for nocturnal enuresis in children aged six years and older after organic causes have been excluded. Effectiveness in enuresis may diminish with prolonged use.
How IMIPRAMINE HYDROCHLORIDE Works
Imipramine hydrochloride is a tricyclic antidepressant (TCA) that inhibits the neuronal reuptake of the neurotransmitters norepinephrine and serotonin (5-HT) at the presynaptic terminals, thereby increasing their concentration in the synaptic cleft. It also exhibits significant anticholinergic (muscarinic), antihistaminic (H1), and alpha-1 adrenergic blocking activities. Its mechanism in treating enuresis is not fully elucidated but is believed to involve its anticholinergic properties, which increase bladder capacity, and its effects on the arousal threshold.
Details
- Status
- Prescription
- First Approved
- 1974-06-27
- Routes
- ORAL
- Dosage Forms
- TABLET, CONCENTRATE
Companies
IMIPRAMINE HYDROCHLORIDE Approval History
What IMIPRAMINE HYDROCHLORIDE Treats
2 indicationsIMIPRAMINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
- Enuresis
IMIPRAMINE 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 imipramine hydrochloride 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 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 imipramine hydrochloride 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. Imipramine hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use )
IMIPRAMINE 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.
Drugs Similar to IMIPRAMINE HYDROCHLORIDE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04863950 | CTMS# 20-0148 | Ph 2 | recruiting | Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma |
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.
IMIPRAMINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)IMIPRAMINE HYDROCHLORIDE is indicated for the treatment of Depression; Enuresis.
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 ...
Looking for the branded version?
TOFRANIL
Full clinical data, patents, trials, and competitive landscape for imipramine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.