In Search of the Ideal Sleep Hypnotic in Long-Term Care
The incidence of insomnia in the nursing home setting is approximately 60%. Prescriptions being written for Food and Drug Administration (FDA)–approved sleep hypnotics in the same setting account for approximately 5% of total prescription writing. The definition of insomnia includes:
• The inability to fall asleep.
• The inability to stay asleep.
• Not feeling refreshed upon awakening.
The second definition of insomnia vexes our traditional prescription writing, in that all sleep hypnotics have to be administered within a safe prescribing window, usually between 8:00 pm and 10:00 pm. In the long-term care (LTC) setting, many residents awaken between 10:00 pm and 3:00 am for a variety of reasons, making it difficult to safely medicate a resident in the middle of the night.
Compound this with the documented high risk of falls and injury associated with sedative-hypnotics, and medical–legal issues arise. Since falls and fractures and the sequelae that follow make up approximately 80% of LTC litigation, a careful review of medication selection is appropriate.
Underutilization of FDA-approved sleep hypnotics is due partly to clinicians underestimating the importance of insomnia on the quality of life of nursing home residents. Other reasons why physicians are hesitant to write for this class of drugs include:
• Concerns about dependence on daily medications.
• Drug Enforcement Administration oversight regarding scheduled agents.
• Safety concerns of nighttime awakenings in patients at high risk for falls.
• Quality Indicator skewing in patients needing apparent “chronic administration” of this class of medication.
In light of the above concerns, poorly rested residents continue to suffer in activities, therapies, the dining room, and overall well-being. Questions we should be asking ourselves include:
• Is the insomnia nightly or sporadic?
• Have all secondary causes been considered?
• Is the insomnia between 8:00 pm and 10:00 pm or between 10:00 pm and 3:00 am?
• Is there a next-day withdrawal phenomenon associated with the sleep hypnotic if it were to be discontinued abruptly?
• Can the sleep hypnotic be given in the middle of the night if necessary?
• How much dedicated sleep time is appropriate for the resident?
Some sedative agents without an FDA indication for sleep induction are currently used to circumvent the regulatory barriers. These may include sedating antidepressants, antihistamines, or antipsychotics used in a subtherapeutic dose range for their adverse effect—sedation. This came about as the survey system punished caregivers for more “chronic” use of sleep hypnotics.
It has become popular to circumvent the Quality Indicator rating either by using medications that are “under the radar screen” of the surveyors, or by adding an additional diagnosis that would support using another medication that has sedating side effects. Either way, the resident may lose out, as in the case of sedation-induced injury. Poor outcomes involving off-label drug use, for sedative effect at known subtherapeutic levels, blur the demarcation line between standard of care and negligence.
The search for the ideal hypnotic in LTC will be one that fits the profile of the resident and gives the prescriber peace of mind. Since the half-life of sleep hypnotics appears to influence middle-of-the-night adverse events more than sleep duration, one should consider a short half-life an asset. Do not anticipate sleep dedication time greater than 4 hours in residents who have a history of nighttime falls. Try to use an agent approved for post-bedtime use for those displaying a pattern of middle-of-the-night awakenings.
Before deciding on a plan for future hypnotic use, make sure you have documented nonpharmacologic interventions such as:
• Decaffeinating the resident
• Addressing emotional issues before bedtime
• Attempting to reduce daytime napping by redirection and increased activities
• Having the resident take a warm bath or shower prior to retiring
• Addressing other secondary causes such as pain, noise levels, roommate issues, etc
Lastly, to avoid failure, do not be afraid to take the resident to the highest recommended geriatric dosage. Often, suspected failure of the medication has been the failure to use the therapeutic dose.
In the future, residents will insist on higher standards regarding the issue of sleep quality in the nursing home. When the importance of sleep hygiene is understood to impact resident well-being, sleep hypnotics will be looked at in a different light. For the sake of the resident, the hope is that it will not take as long to adequately address sleep issues as it did to address pain issues.
Dr. Daniel Cannone reported that he has served on the speakers’ bureau and/or has served as a consultant for Abbott Laboratories, AstraZeneca Pharmaceuticals LP, Aventis Pharmaceuticals Inc., Eli Lilly and Company, Faulding Pharmaceutical Co, Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, LP, King Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Ortho-McNeil Pharmaceutical, Inc., Pfizer Inc, and Wyeth Pharmaceuticals.
Dr. Sean Cannone reported that he has served on the speakers’ bureau and/or has served as a consultant for Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, LP, King Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Ortho-McNeil Pharmaceutical, Inc., Pfizer Inc, and Wyeth Pharmaceuticals.