What to Know About Off-Label Use of Mental Health Medications

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Most medications are formulated to treat a particular condition or set of symptoms. They go through multiple trials and human studies before being approved by the Food and Drugs Association (FDA) for public use.

However, it's common practice for some medications to be prescribed off-label, especially when it comes to mental health conditions. Off-label means that a drug has been prescribed for reasons other than the original intended use for which it was approved.

For instance, medications like antidepressants formulated explicitly for treating depression symptoms have been prescribed for conditions such as anxiety, nerve pain, and bipolar disorder. So much so that it's now a globally accepted medical practice.

This article will tell you all you need to know about the off-label use of mental health medications and how it works.

Off-label Drug Use for Mental Health 

According to the FDA, off-label drug use can be defined as using medication for reasons not outlined in the approved labeling. The labeling is typically a package insert you can find inside a medication's box. It contains all information about the drug and what it's used for.

Whether or not a drug can be prescribed off-label depends on your doctor. Based on your medical and family history, your condition, and a ton of other factors, they'll come to an informed decision on whether to prescribe a medication off-label to you. In general, they have the power to use their discretion to determine in which scenarios prescribing medication off-label will be most effective.

Off-label drug prescription has become commonplace in medical practices across the globe. Your doctor owes you a duty of care to ensure that the decision to put you on off-label medication is the best option for you. Some factors they might consider before prescribing a drug off-label include whether or not the medicine has FDA approval if the off-label use has been studied and peer-reviewed, and if the medication is necessary for your treatment.

Why Medications are Prescribed Off-label 

The healthcare industry has developed in leaps and bounds over the years. However, scientists and researchers remain unrelenting in researching breakthrough medications for several conditions. Even with all the progress made, many conditions remain a little misunderstood.

Medications don't always exist to treat many mental health conditions, creating a need for medications to be prescribed off-label. In some instances, drug manufacturers may later discover that medication has multiple uses; however, the process of reapplication with the FDA can be long and tedious, and they are more than happy to leave doctors to continue to prescribe the medication off-label. 

Medications may be prescribed off-label for any of the following reasons: 

  • You need a lower or higher dose than has been approved by the FDA.
  • To treat a condition that has no approved medications. 
  • You need the medication in a different form, for instance, an oral solution, instead of pills. 

Commonly Prescribed Off-Label Medications for Mental Health Conditions

In a 2015 study, researchers found that off-label drug use was widespread in psychiatry. They identified that Klonopin (clonazepam), Ativan (lorazepam), and Artane (trihexyphenidyl HCl) were the most frequently used off-label.

Benzodiazepines like Klonopin are typically used to treat conditions like anxiety and depression. They've also been used off-label for treating schizophrenia. Artane is used for treating Parkinson's disease but has also been seen to be effective for treating obsessive-compulsive disorder (OCD), bipolar disorder, and schizophrenia. Other commonly prescribed off-label medications for mental health conditions include: 

  • Elavil (amitriptyline): Elavil is a tricyclic antidepressant for treating major depressive disorder. It may also be prescribed off-label for treating post-traumatic stress disorder (PTSD), chronic pain, and insomnia.
  • Desyrel (trazodone): Desyrel is an antidepressant approved for treating major depressive disorder in adults. However, it has historically been prescribed off-label for the treatment of insomnia
  • Minipress (prazosin): Minipress is used for the treatment of hypertension. It has also been proven to effectively help reduce symptoms of PTSD nightmares when prescribed off-label. 
  • Topamax (topiramate): Topamax is used on its own or with other medications for treating epilepsy and migraine disorder. Off-label it's commonly prescribed for psychotropic drug-induced weight gain, alcohol dependence, bulimia, binge eating disorder, and nerve pain. 
  • Catapres (clonidine): Clonidine is an anti-hypertensive medication. In 2010, the FDA approved it for treating attention deficit hyperactive disorder (ADHD) in children. Off-label has proven to be effective in helping with smoking cessation. However, researchers also observed that side effects of the drug for people who smoke limit its effectiveness. 
  • Namenda (memantine): Namenda is approved by the FDA for treating Alzheimer's disease. Studies have shown that it is also effective for treating mild to moderate OCD symptoms.

What Off-Label Medication Means for You 

If you don't pore over the package insert of an off-label medication that has been prescribed for you, in many cases, you are not likely to know when you've been prescribed a drug off-label. You should know that in most cases, the effectiveness of off-label medication has been proven through years of case studies.

Your doctor is in the best place to make a call on what medication you need. Suppose you feel uncomfortable or have any reservations feel free to share them with your doctor. Ask as many questions as necessary to feel comfortable taking the prescribed medication.

Off-label medications can be transformative for people who have tried all of the approved medications for their condition without seeing an improvement in their symptoms. 

10 Sources
Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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By Toketemu Ohwovoriole
Toketemu has been multimedia storyteller for the last four years. Her expertise focuses primarily on mental wellness and women’s health topics.