• Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.
  • Explain the risk assessment you would use to inform your treatment decision  making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
  • Explain whether clinical practice guidelines exist for this disorder, and if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
  • Support your reasoning with at least three current, credible scholarly resources, one each on the FDA-approved drug, the off-label, and a nonpharmacological intervention for the disorder.

Upload a copy of your discussion writing to the draft Turnitin for plagiarism check.  Your faculty holds the academic freedom to not accept your work and grade at a zero if your work is not uploaded as a draft submission to Turnitin as instructed.

Risks and Benefits of the Off-Label Drug

Disorder: Generalized Anxiety Disorder (GAD) in older adults

FDA-Approved Drug: Sertraline (Zoloft)

Off-Label Drug: Buspirone

Nonpharmacological Intervention: Cognitive Behavioral Therapy (CBT)

Risk Assessment: In treating GAD in older adults, the risk assessment is crucial due to potential interactions with other medications, comorbid conditions, and the vulnerability of this population to adverse effects. For sertraline, the benefits include its efficacy in reducing anxiety symptoms and its FDA-approved status, indicating a significant level of safety and effectiveness. However, the risks include potential side effects such as gastrointestinal disturbances, insomnia, and sexual dysfunction. Additionally, there’s a risk of serotonin syndrome, especially when combined with other serotonergic medications.

Buspirone, though not FDA-approved specifically for GAD, is sometimes used off-label for anxiety disorders. Its benefits include a lower risk of dependence compared to benzodiazepines and less sedation. However, the evidence for its effectiveness in older adults is limited, and it may take several weeks to show significant improvement. Risks include potential interactions with other medications and side effects such as dizziness and headaches.

CBT is a nonpharmacological intervention with benefits such as long-term effectiveness and lack of drug-related side effects. However, its availability may be limited due to the need for trained therapists, and it may take time for patients to see significant improvement.

Clinical Practice Guidelines: The American Psychiatric Association (APA) publishes clinical practice guidelines for the treatment of psychiatric disorders, including GAD. These guidelines recommend SSRIs like sertraline as first-line pharmacological treatment for GAD in older adults due to their efficacy and favorable side effect profile. However, they also highlight the importance of considering individual patient factors and preferences in treatment selection. For nonpharmacological interventions, including CBT, APA guidelines recommend them as first-line or adjunctive treatments for GAD.


  1. Baldwin, D. S., & Polkinghorn, C. (2005). Evidence-based pharmacotherapy of generalized anxiety disorder. International Journal of Neuropsychopharmacology, 8(03), 293-302.
  2. Bystritsky, A., Khalsa, S. S., Cameron, M. E., & Schiffman, J. (2013). Current diagnosis and treatment of anxiety disorders. Pharmacy and Therapeutics, 38(1), 30.
  3. Wetherell, J. L., & Gatz, M. (2005). The Beck Anxiety Inventory in older adults with generalized anxiety disorder. Journal of Psychopathology and Behavioral Assessment, 27(1), 17-24.

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