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Review of Safety and Efficacy of Sleep Medicines in Older Adults.

Clinical therapeutics
November 1, 2016
Jennifer L Schroeck et al. (7 authors)
Journal ArticleReviewHuman Study
Study Details

Study Goal

The researchers aimed to evaluate the safety and efficacy of melatonin as an off-label treatment for insomnia in older adults.

Results Summary

The study found that melatonin has a small impact on sleep latency but can produce residual sedation. It is noted as an unregulated product with limited efficacy compared to other treatments.

Population

Older adults with insomnia.

Effective Dosage

Not specified

Duration

Not specified

Interactions

None mentioned

Extracted Claims (15)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Benzodiazepines
neutral
-
geriatric population
-
are discouraged
#1
nonbenzodiazepine receptor agonists (non-BzRAs)
neutral
-
-
-
have improved safety profiles compared with benzodiazepines
#2
nonbenzodiazepine receptor agonists (non-BzRAs)
increase
dementia, serious injury, and fractures
-
-
side effects include
#3
Ramelteon
neutral
-
-
-
has a minimal adverse effect profile
#4
Ramelteon
decrease
sleep-onset latency
-
-
is effective for
#5
Ramelteon
increase
total sleep time
-
-
increased
#6
suvorexant
increase
sleep maintenance
-
-
improves
#7
suvorexant
increase
somnolence
-
-
has mild adverse effects, including
#8
suvorexant
increase
residual daytime sedation
-
-
residual daytime sedation has been reported
#9
Sedating low-dose antidepressants
neutral
-
-
-
should only be used for insomnia when the patient has comorbid depression
#10
Antipsychotic agents, pramipexole, and tiagabine
neutral
-
older population
-
have all been used for insomnia, but none has been extensively studied in an older population, and all have considerable adverse effects
#11
Gabapentin
neutral
-
patients with restless leg syndrome or chronic neuropathic pain and insomnia
-
may be useful in patients with restless leg syndrome or chronic neuropathic pain and insomnia
#12
Diphenhydramine
neutral
-
elderly
-
should be avoided
#13
Valerian and melatonin
decrease
sleep latency
-
small
have a small impact on
#14
Valerian and melatonin
increase
residual sedation
-
-
can produce
#15
Abstract

PURPOSE: Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. METHODS: A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population. Search terms included medications approved by the US Food and Drug Administration for insomnia: benzodiazepines (triazolam, estazolam, temazepam, flurazepam, and quazepam), nonbenzodiazepine receptor agonists (non-BzRAs; zaleplon, zolpidem, and eszopiclone), suvorexant, ramelteon, doxepin and trazodone. Off-label drugs such as other antidepressants, antihistamines, antipsychotics, gabapentin, pramipexole, tiagabine, valerian, and melatonin were also included. FINDINGS: Cognitive behavioral therapy and sleep hygiene are considered initial therapy for insomnia. Benzodiazepines are discouraged in the geriatric population, especially for long-term use. Although non-BzRAs have improved safety profiles compared with benzodiazepines, their side effects include dementia, serious injury, and fractures, which should limit their use. Ramelteon has a minimal adverse effect profile and is effective for sleep-onset latency and increased total sleep time, making it a valuable first-line option. Although the data on suvorexant are limited, this drug improves sleep maintenance and has mild adverse effects, including somnolence; residual daytime sedation has been reported, however. Sedating low-dose antidepressants should only be used for insomnia when the patient has comorbid depression. Antipsychotic agents, pramipexole, and tiagabine have all been used for insomnia, but none has been extensively studied in an older population, and all have considerable adverse effects. Gabapentin may be useful in patients with restless leg syndrome or chronic neuropathic pain and insomnia. Diphenhydramine should be avoided in the elderly. Valerian and melatonin are unregulated products that have a small impact on sleep latency and can produce residual sedation. IMPLICATIONS: An ideal treatment for insomnia should help to improve sleep latency and sleep duration with limited awakenings and be without significant adverse effects such as daytime somnolence or decreased alertness. Cognitive behavioral therapy should always be first line treatment. Clinical inertia regarding previous prominent use of benzodiazepines and non-BzRAs will be a significant challenge for patients accustomed to their issuance. The future direction of insomnia treatment should have an emphasis on nonpharmacologic interventions, treating comorbid conditions, and focusing therapy on using benzodiazepines and non-BzRAs as last resorts.

Medical Subject Headings (MeSH)
AgedHumansHypnotics and SedativesMiddle AgedRandomized Controlled Trials as TopicSleepSleep Initiation and Maintenance Disorders
Study Links
Quality Scores
Safety70
Efficacy40/10
Quality85/10
Citation Metrics
Total Citations221
Citations/Year24.6
Relative Citation Ratio11.75
NIH Percentile98.4%
Research Impact Scores
APT Score0.95
Weight Score2.28
Normalized Score0.61
Related Supplements
Review of Safety and Efficacy of Sleep Medicines in Older Ad... | Panacea Index