Insomnia in Elderly Patients: Recommendations for Pharmacological Management.
Study Goal
The researchers aimed to evaluate the efficacy and safety of melatonin in treating insomnia, particularly in the elderly, and compare it with other FDA-approved and off-label treatments.
Results Summary
Melatonin slightly improves sleep onset and sleep duration, but product quality and efficacy may vary. The abstract notes limited data on benefits and harms, suggesting modest effects.
Population
Elderly individuals with chronic insomnia.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Ramelteon | decrease | sleep-onset insomnia | the elderly | - | can treat | #1 |
short-acting Z-drugs | decrease | sleep-onset insomnia | the elderly | - | can treat | #2 |
Suvorexant | increase | sleep maintenance | the elderly | - | can improve | #3 |
low-dose doxepin | increase | sleep maintenance | the elderly | - | can improve | #4 |
Eszopiclone | increase | both sleep onset and sleep maintenance | the elderly | - | can be utilized for | #5 |
zolpidem extended release | increase | both sleep onset and sleep maintenance | the elderly | - | can be utilized for | #6 |
Low-dose zolpidem sublingual tablets | decrease | middle-of-the-night awakenings | the elderly | - | can alleviate | #7 |
zaleplon | decrease | middle-of-the-night awakenings | the elderly | - | can alleviate | #8 |
Trazodone | increase | sleep quality and sleep continuity | - | - | improves | #9 |
Tiagabine | no change | insomnia | - | - | is not effective | #10 |
Melatonin | increase | sleep onset and sleep duration | - | - | slightly improves | #11 |
Tryptophan | decrease | sleep onset | adults | - | decreases | #12 |
Valerian | neutral | sleep quality | - | - | has equivocal benefits on | #13 |
dual orexin receptor antagonists (almorexant, lemborexant, and filorexant) | increase | sleep maintenance and sleep continuity | - | - | have shown some improvement in | #14 |
Piromelatine | increase | sleep maintenance | - | - | may improve | #15 |
Histamine receptor inverse agonists (APD-125, eplivanserin, and LY2624803) | increase | slow-wave sleep | - | - | improve | #16 |
Chronic insomnia affects 57% of the elderly in the United States, with impairment of quality of life, function, and health. Chronic insomnia burdens society with billions of dollars in direct and indirect costs of care. The main modalities in the treatment of insomnia in the elderly are psychological/behavioral therapies, pharmacological treatment, or a combination of both. Various specialty societies view psychological/behavioral therapies as the initial treatment intervention. Pharmacotherapy plays an adjunctive role when insomnia symptoms persist or when patients are unable to pursue cognitive behavioral therapies. Current drugs for insomnia fall into different classes: orexin agonists, histamine receptor antagonists, non-benzodiazepine gamma aminobutyric acid receptor agonists, and benzodiazepines. This review focuses on Food and Drug Administration (FDA)-approved drugs for insomnia, including suvorexant, low-dose doxepin, Z-drugs (eszopiclone, zolpidem, zaleplon), benzodiazepines (triazolam, temazepam), and ramelteon. We review the indications, dosing, efficacy, benefits, and harms of these drugs in the elderly, and discuss data on drugs that are commonly used off-label to treat insomnia, and those that are in clinical development. The choice of a hypnotic agent in the elderly is symptom-based. Ramelteon or short-acting Z-drugs can treat sleep-onset insomnia. Suvorexant or low-dose doxepin can improve sleep maintenance. Eszopiclone or zolpidem extended release can be utilized for both sleep onset and sleep maintenance. Low-dose zolpidem sublingual tablets or zaleplon can alleviate middle-of-the-night awakenings. Benzodiazepines should not be used routinely. Trazodone, a commonly used off-label drug for insomnia, improves sleep quality and sleep continuity but carries significant risks. Tiagabine, sometimes used off-label for insomnia, is not effective and should not be utilized. Non-FDA-approved hypnotic agents that are commonly used include melatonin, diphenhydramine, tryptophan, and valerian, despite limited data on benefits and harms. Melatonin slightly improves sleep onset and sleep duration, but product quality and efficacy may vary. Tryptophan decreases sleep onset in adults, but data in the elderly are not available. Valerian is relatively safe but has equivocal benefits on sleep quality. Phase II studies of dual orexin receptor antagonists (almorexant, lemborexant, and filorexant) have shown some improvement in sleep maintenance and sleep continuity. Piromelatine may improve sleep maintenance. Histamine receptor inverse agonists (APD-125, eplivanserin, and LY2624803) improve slow-wave sleep but, for various reasons, the drug companies withdrew their products.