Overview
Imipramine, the prototypical tricyclic antidepressant (TCA), is a dibenzazepine-derivative TCA. TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, imipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, imipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as imipramine and amitriptyline, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. TCAs also block histamine H receptors, α-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively . Imipramine has less sedative and anticholinergic effects than the tertiary amine TCAs, amitriptyline and clomipramine. Imipramine may be used to treat depression and nocturnal enuresis in children . Unlabeled indications include chronic and neuropathic pain (including diabetic neuropathy), panic disorder, attention-deficit/hyperactivity disorder (ADHD), and post-traumatic stress disorder (PTSD) .
Indication
For the relief of symptoms of depression and as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older . May also be used off-label to manage panic disorders with or without agoraphobia, as a second line agent for ADHD in children and adolescents, to manage bulimia nervosa, for short-term management of acute depressive episodes in bipolar disorder and schizophrenia, for the treatment of acute stress disorder and posttraumatic stress disorder, and for symptomatic treatment of postherpetic neuralgia and painful diabetic neuropathy .
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Bulimia Nervosa
- Depression
- Enuresis
- Neuropathic Pain
- Panic Disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/01/16 | Phase 2 | Recruiting | |||
2024/07/12 | Not Applicable | Recruiting | |||
2024/03/15 | Phase 2 | Recruiting | |||
2023/01/18 | Phase 1 | Recruiting | |||
2023/01/10 | Phase 3 | Recruiting | |||
2021/04/28 | Phase 2 | Recruiting | |||
2020/08/20 | Phase 1 | Recruiting | |||
2020/06/02 | Phase 3 | Withdrawn | |||
2019/05/22 | Early Phase 1 | Withdrawn | |||
2017/04/20 | Early Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Hikma Pharmaceuticals USA Inc | 0054-0273 | ORAL | 75 mg in 1 1 | 2/3/2017 | |
REMEDYREPACK INC. | 70518-3438 | ORAL | 50 mg in 1 1 | 1/11/2024 | |
PD-Rx Pharmaceuticals, Inc. | 72789-243 | ORAL | 25 mg in 1 1 | 9/25/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-2730 | ORAL | 50 mg in 1 1 | 5/23/2022 | |
Par Pharmaceutical, Inc. | 49884-054 | ORAL | 10 mg in 1 1 | 9/12/2023 | |
Leading Pharma, LLC | 69315-133 | ORAL | 10 mg in 1 1 | 10/28/2022 | |
REMEDYREPACK INC. | 70518-3526 | ORAL | 25 mg in 1 1 | 1/15/2024 | |
Lupin Pharmaceuticals, Inc. | 68180-316 | ORAL | 125 mg in 1 1 | 11/1/2023 | |
Leading Pharma, LLC | 69315-135 | ORAL | 50 mg in 1 1 | 10/28/2022 | |
PD-Rx Pharmaceuticals, Inc. | 72789-244 | ORAL | 50 mg in 1 1 | 9/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AA PHARMA IMIPRAMINE TABLET 25MG | SIN04154P | TABLET, FILM COATED | 25 mg | 4/20/1990 | |
AA PHARMA IMIPRAMINE TABLET 10MG | SIN04155P | TABLET, FILM COATED | 10 mg | 4/20/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Imipramine Hydrochloride tablets | 国药准字H19994048 | 化学药品 | 片剂(糖衣片) | 1/15/2020 | |
Imipramine Hydrochloride tablets | 国药准字H31021201 | 化学药品 | 片剂(糖衣) | 2/26/2020 | |
Imipramine Hydrochloride tablets | 国药准字H31020406 | 化学药品 | 片剂 | 2/26/2020 | |
Imipramine Hydrochloride tablets | 国药准字H31021551 | 化学药品 | 片剂(糖衣) | 12/4/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack | 60673 | Medicine | A | 9/16/1997 | |
TOFRANIL 10 imipramine hydrochloride 10mg tablet blister pack | 11064 | Medicine | A | 8/2/1991 |
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