Overview
Dosulepin (INN, BAN) formerly known as dothiepin (USAN), is a tricyclic antidepressant with anxiolytic properties that is used in several European and South Asian countries, as well as Australia, South Africa, and New Zealand. It is not FDA-approved due to low therpeutic index and significant toxicity in overdose. Dosulepin inhibits the reuptake of biogenic amines, increasing available neurotransmitter levels at the synaptic cleft. The use of dosulepsin is only recommended in patients who are intolerant or unresponsive to alternative antidepressant therapies. Dosulepsin is a thio derivative of Amitriptyline with a similar efficacy to that of Amitriptyline, and also exhibits anticholinergic, antihistamine and central sedative properties . Its hydrochloride form is a common active ingredient in different drug formulations.
Background
Dosulepin (INN, BAN) formerly known as dothiepin (USAN), is a tricyclic antidepressant with anxiolytic properties that is used in several European and South Asian countries, as well as Australia, South Africa, and New Zealand. It is not FDA-approved due to low therpeutic index and significant toxicity in overdose. Dosulepin inhibits the reuptake of biogenic amines, increasing available neurotransmitter levels at the synaptic cleft. The use of dosulepsin is only recommended in patients who are intolerant or unresponsive to alternative antidepressant therapies. Dosulepsin is a thio derivative of Amitriptyline with a similar efficacy to that of Amitriptyline, and also exhibits anticholinergic, antihistamine and central sedative properties . Its hydrochloride form is a common active ingredient in different drug formulations.
Indication
Indicated in the treatment of symptoms of depressive illness, especially where an anti-anxiety effect is required.
Associated Conditions
- Anxiety
- Depression
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/31 | Phase 4 | Recruiting | All India Institute of Medical Sciences, Bhubaneswar | ||
2017/04/24 | N/A | Completed | All India Institute of Medical Sciences, Bhubaneswar |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| ESPIN CAPSULE 25 mg | SIN10607P | CAPSULE | 25 mg | 1/6/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| DOSULEPIN VIATRIS 25 dosulepin (dothiepin) hydrochloride 25 mg hard capsule blister pack | 289783 | Medicine | A | 8/23/2017 | |
| DOTHEP 25 | 34419 | Medicine | A | 12/24/1991 | |
| DOSULEPIN VIATRIS 75 dosulepin (dothiepin) hydrochloride 75 mg film coated tablet blister pack | 289784 | Medicine | A | 8/23/2017 | |
| Dosulepin (dothiepin) 75 mg tablet blister pack | 343460 | Medicine | A | 9/14/2020 | |
| DOTHEP 75 | 62910 | Medicine | A | 1/23/1998 |