Mind Matters - October 2007
Written by Ron Sterling, M.D. and Published in Northwest Prime Time Magazine

Off-Label Drug Use
by Ron Sterling, M.D. -- October 2007

    Dear Dr. Ron:

      My father is living in an Alzheimer's unit of an assisted living residence. I had to move him there because of his angry outbursts, increased paranoid thinking, and how disruptive he was at night to my family's sleep. He is being prescribed a "cocktail" of medications including Namenda®, trazodone, Neurontin®, Zyprexa®, mirtazapine, and hydrochlorthiazide and lisinopril for mild heart failure. I think I understand why each medication is being used, but I have also read that there is some controversy about "off-label" uses of some of these medications. Can you comment? Signed: Concerned About Off-Label Drug Use.

    Dear Concerned:

      Thank you for writing! Off-label prescriptions for various symptoms have skyrocketed over the last 15 years. It is worth our concern. One of the frequent results of off-label prescribing is polypharmacy (the use of many drugs at the same time). Polypharmacy is especially worrisome in the older adult population.

      The term "off-label" refers to the use of a medication for symptoms or disorders that have not been approved by the Federal Drug Administration (FDA). The FDA definition of "off-label" is very complex and outside the scope of this short column. For instance, trazodone (an antidepressant) has often been used for sleep disorders, which is an off-label use in the absence of a diagnosis such as major depressive disorder.

      Polypharmacy in older adults is a concern because several studies have confirmed that it is a significant risk factor for (1) increased adverse reactions, and (2) non-compliance. Some studies have shown that potentially harmful drug interactions were identified in 54 per cent of older adult nursing home residents taking two or more drugs. A study published in early 2006 examining the relationship between polypharmacy (four or more drugs in one day) and falling down found a strong association between older age, number of drugs, and the risk for falling and injury.

      A large study published later in 2006 using Medicaid recipients in Georgia found that most of the off-label use of drugs and associated polypharmacy was much more prevalent in older adult populations than younger. It might make sense that an older adult population might utilize more medications due to chronic and possibly higher rates of illness, but that does not translate into more off-label use. Although the authors of the study could not conclude whether the off-label uses they found were appropriate or not, the most prevalent off-label medications were antidepressants (Zoloft® and amitriptyline), anticonvulsants (Neurontin®) and antipsychotics (risperidone and Zyprexa®).

      Given what I know from your question, I cannot conclude whether the drugs you have listed fit the criteria for the definition of off-label use. Because Alzheimer's Disease is a very complex, slow, brain degeneration, many problematic symptoms can arise which need to be addressed, including very disturbed sleep-wake cycles, irritability, aggressiveness, and psychosis. Neurontin® is among a class of anticonvulsants such as Depakote®, Tegretol®, and Trileptal®, which can be very useful in stabilizing moods. Zyprexa® is an antipsychotic medication (the class includes Haldol®, Risperdal®, Abilify®, etc.) which can be helpful for delusional thinking and other psychotic symptoms. Mirtazapine (Remeron®) is an antidepressant which has sedating and appetite inducing side effects which can be very helpful in Alzheimer's Disease for assisting with sleep and appetite loss (poor nutrition).

      The only potential off-label medication in the list you provided that might be replaced by some other medication might be trazodone. Although trazodone has been an off-label mainstay for treating sleep disorders in the elderly for years, we now have other, better sleeping medications, such as Lunesta® and Rozerem®. The benzodiazepine-type medications (Ambien®, Valium®, Klonopin®, etc.) are to be avoided in older adults due to their higher risk of inducing falls.

      For doctors, the principles are "monitor, monitor, monitor, keep medications to the minimum necessary, and document appropriate diagnoses." For patients and their families, the principles are "question, question, question and advocate for minimum number of medications necessary." I hope that is helpful. -- Best wishes, Dr. Ron.

        Author Bio:

        Ron Sterling, M.D. is a 64 year-old General and Geriatric Psychiatrist with a private practice in Bellevue, Washington. He invites you to e-mail him at with any questions about mental wellness or emotional, relationship, or aging concerns. He is the only person who reads e-mail sent to Dr. Ron. Please be assured that your questions and identities are completely confidential and protected. For more information about Dr. Ron and for resources related to senior mental health, please go to SeniorMentalHealth.org. The content offered through Mind Matters is for information only and is not intended for medical, psychiatric, or psychological diagnosis or treatment. Never disregard professional advice or delay seeking it because of something you have read in this column. Read our Disclaimer. If you wish to understand more about Dr. Sterling's potential biases in health care advocacy, please check his Conflicts of Interest Disclosure Statement

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