Editors from The American Journal of Managed Care® (AJMC®) spoke with Nicole Brandt, PharmD, MBA, BCPP, BCGP, FASCP, executive director of The Peter Lamy Center on Drug Therapy and Aging and professor of pharmacy practice and science at the University of Maryland School of Pharmacy in Baltimore, Maryland, to discuss treatments for insomnia in older adults.
AJMC®: Would you explain some of the safety issues associated with the use of medications for sleep disorders in older patients?
Brandt: As patients age, they tend to use more medications, and so it is especially important to think about interactions between drugs when prescribing treatments in older adults. For example, [some] medications prescribed for sleep disorders may interact with other agents and affect brain health, such as psychotropic medications. Healthcare providers must think about the burden of the treatments, as well as the burden of the disease. [Some medications] can increase the risk of confusion, whereas other medications such as benzodiazepines or nonbenzodiazepine, benzodiazepine receptor agonists [Z-drugs] can increase the risk of confusion, falls, fractures, and motor vehicle accidents. Older adults have decreased ability to rebound from a fall, and so healthcare providers need to be concerned about an older patient falling, which could lead to fracturing a hip.
The vulnerability is greater for older adults, and that’s why there is a heightened conscientiousness around the medicine-to-harm ratio for some of the safety implications of sleep medication.
AJMC®: How do the American Geriatrics Society Beers Criteria aid the management of medications in older adults, particularly for sleep disorders?
Brandt: The Beers Criteria has evolved since its inception in 1991 and subsequent adoption by the American Geriatrics Society (AGS) in 2012, when the AGS took on the cause to lead further updates. The criteria consist of multiple lists of medications for which there has been a lot of discussion around potentially inappropriate use and for which the harms of their use may outweigh the benefits in older adults with certain conditions. The goal of the criteria is to educate current and future healthcare providers, policy makers, payers, and the industry at large, including patients and caregivers, on the risks and benefits of medications as people age. One caveat of the Beers Criteria is that they should not be applied to patients who are in hospice care settings.1
Looking at the different lists within the Beers Criteria, the one that most people refer to is known as the potentially inappropriate medication [PIM] list. Between 2012 and 2015, the AGS started to review potential medication interactions and drug-drug interactions, in addition to noting increased risk of falls associated with some medications in older adults, and now the Beers Criteria include a list of medications that are potentially more problematic or cause harmful drug-drug interactions in older adults.1
With regard to sleep medications and associated reactions, an example would be benzodiazepine and opioids, which have been shown to increase the risk of respiratory depression and, potentially, death. The FDA has also issued a warning about this.2 Something that many individuals may not think about, however, is central nervous system drug burden. When using multiple medications (≥ 3) from different classes, such as sedative hypnotics, antipsychotics, and antidepressants, there is a greater risk of vulnerability and safety in older adults. Furthermore, there is a medication list to consider in patients who have a renal impairment. As patients age, renal function declines, and some medications, such as duloxetine, are renally eliminated.1
Medications included in Beers Criteria are often commonly used medications, and they are reviewed based on the grade of evidence available. A medication is included when the evidence indicates that the drug’s harm could outweigh its benefits. A breakdown of the different grades of evidence is included, and evidence tables are embedded on the electronic version. This information supports the use of the criteria as an educational tool.1
I want to stress that the Beers Criteria is a tool to supplement good clinical judgment when caring for older adults. Providers need access to medication safety guidance that is presented in an explicit and user-friendly way. Ultimately, it is the practitioner’s clinical discussion. The goal of the criteria is not to say that a practitioner cannot use a particular medication on the list; rather, it is there to encourage practitioners to review the potential associated harm versus the benefit.
Health systems, providers, and payers have adopted the AGS Beers Criteria in myriad ways, from embedding it into automated provider workflows to providing it to pharmacists to use during a comprehensive medication review. This tool can utilized in many ways to optimize medication use and safety in older adults.
AJMC®: Can you explain why medications would not be included in the Beers Criteria?
Brandt: Just because a medication is not listed on the Beers Criteria PIM list does not mean that it is endorsed or without any risk in older adults. It might just be that the medication is not yet well studied in older adults. In addition, some medications have dropped off the Beers list because either they are not that commonly used or newer evidence indicates that they are safer [than previously shown].
Medications are not well studied in older adults with the most vulnerability, especially those individuals who are older than 75 years. Furthermore, it can take 4 to 5 years to see postmarketing safety data. [To this end] there is a need for more studies and more data on treatment in patients over the age of 75 and patients over the age of 85. There also needs to be more data in the population of patients aged 65 to 75 with multiple chronic comorbidities.
AJMC®: What considerations and challenges do practitioners face when prescribing an agent for insomnia in an older adult?
Brandt: The first rule of thumb when treating older adult patients is to try to consider nonpharmacologic treatment because of the considerations previously discussed. Nonpharmacologic treatment could involve a number of things, from ensuring that patients are practicing good sleep hygiene to behavioral therapy. Practitioners also want to determine whether there is something underlying the insomnia that needs to be addressed first, such as anxiety, depression, or pain.
Often, patients are impatient to experience relief, so a practitioner may look to an over-the-counter treatment, such as melatonin, but it depends on whether the patient has a problem staying asleep or falling asleep. Many older adults struggle with sleep-maintenance insomnia versus sleep-onset insomnia, and so [the practitioner may want to consider] agents that have come to market recently and are showing an impact on duration of sleep at night but without a negative clinical impact. For example, emerging evidence for newer agents, such as suvorexant, are showing improved duration of sleep without an impact on cognition, which might be very important in older adults who have coexisting dementia either from Alzheimer disease (AD) or possibly a vascular origin.3
AJMC®: How do comorbid conditions such as AD or other neurodegenerative disorders affect treatment of insomnia?
Brandt: Sleep disturbances are common in patients with AD. This may be due to poor sleep hygiene and sleeping during the day. In addition, the neurodegenerative disease itself affects a patient’s sleep structure.4 Therefore, it is important to look at medications that have been studied explicitly in patients with AD and [make sure] that the medication does not worsen the cognitive function of the patient. Commonly prescribed medications such as lorazepam have well-documented evidence that they may worsen cognitive function for the short and long term. Data from a recent poster presentation showed that suvorexant may be safe in patients with AD5,6; however, good comparative data looking at one agent versus another are lacking. [That type of comparison] is not done in the clinical trials and so we are often comparing drug X versus nothing.
There are many unmet needs when caring for older adults and better guidelines in managing and older adults are sorely needed.
AJMC®: From a pharmacist’s perspective, what are the challenges in terms of coverage of different medications to treat insomnia?
Brandt: There is a lot of disparity among formularies. The prior authorization process can be quite painful for patients, providers, and pharmacies. How newer agents are placed on the different [formulary] tiers can have a huge impact on access for patients on a fixed income. These access costs are a big concern because it is possible that there are other agents the patient and provider have not tried, and even if they gain access to them, they may be too costly for the patient.