Who hasn’t suffered through a sleepless night or two? There is, however, a population that suffers with sleeplessness as a chronic problem that deserves special attention. Much effort has been made to establish consistent, nationwide guidelines to manage and treat chronic insomnia. The American Academy of Sleep Medicine (AASM) has issued new recommendations and guidelines for the pharmacologic treatment of chronic insomnia.
It’s important to establish and define this population struggling with chronic insomnia. Chronic insomnia is defined as persistent difficulty in initiating and/or maintaining sleep for at least three nights per week, lasting at least three months. In order to be considered “a disorder,” there have to be daytime consequences, either in the form of fatigue or sleepiness that interferes with daytime performance.
In order to be considered primary insomnia, the disorder must not be due to another cause (health conditions or medications that could cause insomnia). The current guidelines state that the most effective long-lasting treatment for this condition is cognitive behavioral therapy (CBT). This treatment takes time and it may be difficult to find a skilled practitioner. Not surprisingly, most people opt for sleeping medications.
The AASM created a task force to determine which drug agents are best suited as an adjunct in the treatment of chronic insomnia. The goal was to create standardized evidence-based recommendations to guide proper use of the many pharmacologic agents currently used. Data from different studies with different patient populations was reviewed and outcomes compared in order to develop the guidelines. The data compiled came from studies involving 129 different populations studied from 2011 to 2016.
The task force focused on six outcomes resulting from the use of medications:
- Sleep latency, or the time it takes to fall asleep
- Waking after sleep onset (number of minutes)
- Total sleep time
- Quality of sleep as determined by questionnaires
- Number of awakenings
- Sleep efficiency or a ratio of time in bed versus actual sleep minutes
The strategy of analyzing previous studies and taking results and then constructing another query to determine “new” outcome data is known as meta-analysis. The advantages of using this approach is that it increases the size of the population studied, thereby offering more robust data.
A meta-analysis approach may have some disadvantages. It looks at a population in a different context and not all the studies being used in the analysis necessarily select the populations with the same criteria. Unexpected data may result frequently from bias in population selection. It may create exaggerated findings since studies with negative outcomes are less likely to be published, so end point data can be skewed, affecting the meta-analysis findings.
In this case the results were assessed for quality of evidence and then grades of recommendation were determined. There was some difficulty in comparing different studies, since some had objective data from sleep studies but others relied on sleep diaries, which are subjective and less reliable. The other factor that led to grade of recommendation was the benefits versus harms of different sleeping agents examined in the original studies.
The guidelines provided “weak level of recommendations.” A weak recommendation is defined as one that reflects lower degree of certainty in the appropriateness of the recommendations and defers to the clinician to use his own knowledge and experience coupled with guidelines. The detailed description of each drug recommendation is clearly identified in the full set of guidelines.
The following is a summary of findings and recommendations:
The most commonly used drugs are the benzo-receptor agonists Eszopiclone (Lunesta),which had weak recommendation for sleep maintenance, Zolpidem (Ambien), which had weak recommendation for initiation of sleep. These drugs had a warning to beware of side effects like amnesia during the night.
Benzodiazepines — an older group of more traditional drugs — includes Temazepam (Restoril), which received weak recommendation for sleep onset band only in the adult population. Use with caution in the senior population because of its long action.
Melatonin receptor agonists a group which includes Ramelteon (Rozerem) received a weak recommendation for the initiation of sleep. Overall, it did score a more positive review on benefits versus harms.
Orexin-antagonist Suvorexant is currently the only drug in this newer class. Orexin is the hormone that keeps us awake, so this agent blocks that pathway. The drug received a weak recommendation for maintenance of sleep.
Antidepressants that are most commonly used for sleep include Trazodone and Quetiapine (Seroquel). These drugs should be used with caution since they cause daytime sedation as well. They received a weak recommendation against their use for the treatment of chronic insomnia.
Over-the-counter (OTC) agents, melatonin, valerian, diphenhydramine (Benadryl), and tryptophan were all given only weak recommendations against use for sleep initiation and maintenance.
Some final points:
There were no strong statements of recommendation from this large study
Careful use and individual consideration of all pharmacologic sleep agents given their side effects, was a major recommendation
Lunesta and Suvorexant were the only two agents that scored favorably overall, though weak recommendation was given. This due to the common complaint of wakefulness after falling asleep and then not being able to re-initiate sleep.
All the popular OTC medications do not show any significant efficacy, based on the meta-analysis
Treatment of chronic insomnia is frustrating, so patients should continue to engage with a sleep expert to find a personalized regimen that works for them. Medications should be used only as adjunct to a well-defined program of sleep hygiene (possibly including yoga) coupled with insomnia focused CBT.