From the Guidelines
Eszopiclone, zolpidem, and suvorexant are the most effective medications for short-term treatment of insomnia, with low to moderate strength evidence supporting their use. These medications, including eszopiclone (Lunesta, 1-3mg) and zolpidem (Ambien, 5-10mg), are non-benzodiazepine "Z-drugs" that work by enhancing GABA activity in the brain to promote sleep 1. Suvorexant (Belsomra, 5-20mg) is an orexin receptor antagonist that has also been shown to be effective in improving sleep outcomes 1.
Key Considerations
- These medications should generally be used for short periods (2-4 weeks) due to dependency risks and potential for adverse effects such as cognitive and behavioral changes, including driving impairment 1.
- The FDA recommends dose reduction in women and older adults, and advises against using these medications for extended periods 1.
- Other prescription options, such as melatonin receptor agonists like ramelteon (Rozerem, 8mg) and certain antidepressants at lower doses, may also be considered, but the evidence for their effectiveness is limited or low-strength 1.
- It is essential to address sleep hygiene practices and consider cognitive behavioral therapy for insomnia (CBT-I) as a first-line treatment, with medications used as a temporary solution while addressing underlying causes of sleep difficulties 1.
Potential Harms
- Observational studies have suggested that use of hypnotics for insomnia may be associated with increased risk for dementia, fractures, and major injury 1.
- The FDA has reported that most pharmacotherapies have risks for cognitive and behavioral changes, including driving impairment, and other adverse effects 1.
Conclusion
Given the potential benefits and harms, the most appropriate medication for insomnia should be chosen based on individual patient needs and circumstances, with careful consideration of the potential risks and benefits. It is crucial to weigh the benefits of improved sleep outcomes against the potential risks of adverse effects and to closely monitor patients for any signs of dependency or other adverse effects 1.
From the FDA Drug Label
The effectiveness of eszopiclone was established in five controlled studies in chronic insomnia. The effectiveness of ramelteon was established in three randomized, doubleblind trials in subjects with chronic insomnia employing polysomnography (PSG)
The medications indicated for sleep aid are:
- Ramelteon (2)
- Eszopiclone (3)
From the Research
Medications Indicated for Sleep Aid
The following medications are indicated for sleep aid:
- Zolpidem: a non-benzodiazepine hypnotic indicated for the short-term treatment of insomnia 4, 5
- Ramelteon: a selective melatonin receptor agonist approved for the treatment of insomnia 6
- Eszopiclone: a hypnotic drug belonging to a newer group of hypnotic agents, effective for the treatment of chronic primary insomnia in non-elderly and elderly subjects 7, 8
Characteristics of Each Medication
- Zolpidem:
- Improves sleep in patients with insomnia
- Has a low propensity to cause clinical residual effects, withdrawal, dependence, or tolerance
- Associated with minimal rebound insomnia
- Ramelteon:
- Reduces subjective sleep latency and improves sleep quality
- Associated with improvement in latency to persistent sleep, sleep efficiency, and total sleep time
- Somnolence is a significant adverse event
- Eszopiclone:
- Effective for the treatment of chronic primary insomnia in non-elderly and elderly subjects
- Reduces sleep onset latency, wake time after sleep onset, and increases total sleep time
- Associated with adverse events such as unpleasant taste, dry mouth, somnolence, and dizziness
Considerations for Use
- Zolpidem:
- Should be prescribed with caution in elderly patients due to the risk of falls and hip fractures
- Associated with an increased risk of complex behaviors, such as sleepwalking and driving while asleep
- Ramelteon:
- Long-term trials are needed to establish its clinical impact
- Eszopiclone:
- Should be used with caution in elderly individuals with cognitive and motor impairments
- Increased caution is required in individuals who are at increased risk of using eszopiclone in a non-recommended way