FDA-Approved Uses of Antidepressants

Antidepressants are approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific mental health conditions. These approved, or “on-label,” uses include:

• Major Depressive Disorder (MDD)

• Generalized Anxiety Disorder (GAD)

• Panic Disorder

• Obsessive-Compulsive Disorder (OCD)

• Post-Traumatic Stress Disorder (PTSD)

• Social Anxiety Disorder

• Premenstrual Dysphoric Disorder (PMDD)

• Bulimia Nervosa

• Smoking Cessation (specifically for bupropion)

These diagnoses are outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), published by the American Psychiatric Association. The DSM serves as the primary reference for mental health professionals in the United States and many other countries, providing standardized criteria for the classification of mental disorders. The current edition, DSM-5, introduced significant changes to the diagnostic criteria for major depressive disorder (MDD).​

One notable change in DSM-5 was the removal of the “bereavement exclusion.” In previous editions, such as DSM-IV, clinicians were advised not to diagnose MDD in individuals experiencing depressive symptoms within two months following the death of a loved one, unless specific severe symptoms were present. This exclusion acknowledged that grief can produce symptoms of depression, but considered them a normal response to loss. By eliminating this exclusion, DSM-5 allows for the diagnosis of MDD in grieving individuals as early as two weeks after a loss, contributing to the increased medicalization of normal grief responses.​

---

Common Off-Label Uses of Antidepressants

In clinical practice, antidepressants are frequently prescribed for conditions beyond their FDA-approved indications. These off-label uses include:

• Insomnia: Trazodone is commonly prescribed for sleep disturbances, despite limited evidence supporting its efficacy for this purpose. ​

• Chronic Pain Conditions: Tricyclic antidepressants (e.g., amitriptyline) and SNRIs (e.g., duloxetine) are used for neuropathic pain, fibromyalgia, and migraines. 

• Irritable Bowel Syndrome (IBS): SSRIs are sometimes prescribed for IBS. ​

• Premature Ejaculation: SSRIs like paroxetine and sertraline are used to delay ejaculation, leveraging their side effect of sexual dysfunction.

• Autism Spectrum Disorders (ASD): SSRIs have been explored for managing certain ASD symptoms, but studies have not demonstrated significant benefits.

• Smoking Cessation: Bupropion is FDA-approved for this use, while other antidepressants are sometimes used off-label to aid in quitting smoking. ​

• Eating Disorders: Antidepressants are prescribed for conditions like bulimia and binge eating disorder.

• Menopausal Symptoms: SSRIs such as paroxetine are prescribed for hot flashes and mood swings associated with menopause.

• ADHD and Narcolepsy: Bupropion has been used off-label for attention-deficit/hyperactivity disorder and narcolepsy.

• Impulse Control Disorders: SSRIs have been prescribed for conditions like kleptomania and pathological gambling.

• Neurocardiogenic Syncope: SSRIs have been explored as a treatment option.

• Paraphilic Disorders and Hypersexuality: SSRIs may be prescribed for compulsive sexual behaviors, leveraging their side effect of sexual dysfunction.