FDA Approval Status for Desipramine
Desipramine hydrochloride tablets are FDA-approved for the treatment of depression. 1
Approved Indication
- Desipramine is indicated specifically for the treatment of depression, as stated in the FDA drug label 1
- This represents the sole FDA-approved indication for this tricyclic antidepressant 1
Clinical Context and Usage Patterns
While desipramine has FDA approval for depression, its use has significantly declined in clinical practice, particularly in children and adolescents, due to safety concerns including associations with sudden death. 2
Evidence for Efficacy
- Long-term maintenance therapy with desipramine demonstrated significant efficacy in preventing relapse of chronic depression, with relapse rates of only 11% in the active medication group compared to 52% in the placebo group over up to 2 years of maintenance treatment 3
- Desipramine showed effectiveness in chronic depression subtypes including pure dysthymia, double depression, and chronic major depression 4, 3
- Most relapses in placebo-treated patients occurred within the first 6 months, supporting the value of sustained treatment 3
Dosing Considerations
- In adults, desipramine dosing typically ranges from 100-300 ng/mL plasma concentration for therapeutic effect 2
- For elderly patients with depression, desipramine can be initiated at 10-25 mg in the morning with a maximum of 150 mg daily 2
- Desipramine tends to be activating (reduces apathy) and has lower risk for cardiotoxic, hypotensive, and anticholinergic effects compared to other tricyclics, though it may cause tachycardia 2
- Therapeutic blood level monitoring may be helpful to optimize dosing 2
Critical Safety Warnings
Cardiac toxicity is a major concern with desipramine and all tricyclic antidepressants. 2
- Prescribe with extreme caution in patients with ischemic cardiac disease or ventricular conduction abnormalities 2
- Limit dosages to less than 100 mg/day when possible 2
- Obtain a screening electrocardiogram for patients older than 40 years before initiating treatment 2
- The use of tricyclics in children has fallen off due to association with sudden death in five children reported a decade ago 2
Pediatric Population
Desipramine is NOT recommended for routine use in adolescent depression based on controlled trial data. 5
- A fixed-dose, placebo-controlled trial in 60 adolescents (ages 15-19) with major depressive disorder showed no significant differences in treatment outcome between desipramine (200 mg daily) and placebo after 6 weeks 5
- Neither desipramine nor its metabolite levels correlated with treatment outcome in adolescents 5
- The desipramine group endorsed more side effects, with significantly increased heart rate compared to placebo 5
Time to Therapeutic Effect
- It can take 6 to 8 weeks, including 2 weeks at the highest dosage tolerated, for an adequate trial of treatment with desipramine 2
Off-Label Uses
Desipramine is recommended as a first-line option for neuropathic pain, particularly as a secondary-amine tricyclic antidepressant alongside nortriptyline 2
Current Clinical Position
In contemporary practice, desipramine has been largely supplanted by newer antidepressants with more favorable safety profiles, particularly selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) 2. For elderly patients specifically, preferred agents include citalopram, escitalopram, sertraline, mirtazapine, and venlafaxine rather than tricyclics like desipramine 2, 6.