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Dialnet AprovechamientoDeResiduosOrganicosAgricolasYForest 5633579 PDF
Dialnet AprovechamientoDeResiduosOrganicosAgricolasYForest 5633579 PDF
Description: The American College of Physicians (ACP) devel- Recommendation 1: ACP recommends that all adult patients
oped this guideline to present the evidence and provide clinical receive cognitive behavioral therapy for insomnia (CBT-I) as the
recommendations on the management of chronic insomnia dis- initial treatment for chronic insomnia disorder. (Grade: strong rec-
order in adults. ommendation, moderate-quality evidence)
Methods: This guideline is based on a systematic review of ran- Recommendation 2: ACP recommends that clinicians use a
domized, controlled trials published in English from 2004 shared decision-making approach, including a discussion of the
through September 2015. Evaluated outcomes included benefits, harms, and costs of short-term use of medications, to
global outcomes assessed by questionnaires, patient-reported decide whether to add pharmacological therapy in adults with
sleep outcomes, and harms. The target audience for this guide- chronic insomnia disorder in whom cognitive behavioral therapy
for insomnia (CBT-I) alone was unsuccessful. (Grade: weak rec-
line includes all clinicians, and the target patient population in-
ommendation, low-quality evidence)
cludes adults with chronic insomnia disorder. This guideline
grades the evidence and recommendations by using the ACP
grading system, which is based on the GRADE (Grading of Rec- Ann Intern Med. 2016;165:125-133. doi:10.7326/M15-2175 www.annals.org
ommendations Assessment, Development and Evaluation) For author affiliations, see end of text.
approach. This article was published at www.annals.org on 3 May 2016.
* This paper, written by Amir Qaseem, MD, PhD, MHA; Devan Kansagara, MD, MCR; Mary Ann Forciea, MD; Molly Cooke, MD; and Thomas D. Denberg, MD,
PhD, was developed for the Clinical Guidelines Committee of the American College of Physicians. Individuals who served on the Clinical Guidelines Com-
mittee from initiation of the project until its approval were Mary Ann Forciea, MD† (Chair); Thomas D. Denberg, MD, PhD† (Immediate Past Chair); Michael J.
Barry, MD†; Cynthia Boyd, MD, MPH‡; R. Dobbin Chow, MD, MBA†; Molly Cooke, MD†; Nick Fitterman, MD†; Russell P. Harris, MD, MPH†; Linda L. Humphrey,
MD, MPH†; Devan Kansagara, MD, MCR†; Scott Manaker, MD, PhD†; Robert McLean, MD†; Tanveer P. Mir, MD‡; Holger J. Schünemann, MD, PhD‡; Sandeep
Vijan, MD, MS†; and Timothy Wilt, MD, MPH‡. Approved by the ACP Board of Regents on 25 July 2015.
† Author (participated in discussion and voting).
‡ Nonauthor contributor (participated in discussion but excluded from voting).
www.annals.org, for a description of these interven- Table. The American College of Physicians' Guideline
tions). Cognitive behavioral therapy for insomnia is Grading System*
multimodal cognitive behavioral therapy targeted spe-
cifically to insomnia. It consists of a combination of cog- Quality of Strength of Recommendation
Evidence
nitive therapy, behavioral interventions (such as sleep
Benefits Clearly Outweigh Risks Benefits Finely Balanced
restriction and stimulus control), and educational inter- and Burden or Risks and Burden With Risks and Burden
ventions (such as sleep hygiene). Various delivery Clearly Outweigh Benefits
methods are available, including in-person individual High Strong Weak
or group therapy, telephone- or Web-based modules, Moderate Strong Weak
and self-help books. Trained clinicians or mental health Low Strong Weak
professionals can administer CBT-I.
Pharmacologic therapy in the United States in- Insufficient evidence to determine net benefits or risks
cludes drugs approved by the U.S. Food and Drug Ad- * Adopted from the classification developed by the GRADE (Grading
ministration (FDA) for insomnia treatment, including of Recommendations Assessment, Development, and Evaluation)
workgroup.
benzodiazepines (triazolam, estazolam, temazepam,
flurazepam, and quazepam); nonbenzodiazepine hyp-
notics (zaleplon, zolpidem, and eszopiclone); the re- pidem, eszopiclone, ramelteon, suvorexant, off-label
cently approved orexin receptor antagonist suvorexant; use of drugs (such as antidepressants and antipsychot-
the melatonin receptor agonist ramelteon; the antide- ics), and melatonin; and complementary and alterna-
pressant doxepin; off-label use of drugs, such as other tive approaches, including acupuncture and Chinese
antidepressants, antihistamines, and antipsychotics; herbal medicine. Evaluated outcomes included global
and melatonin. outcomes assessed by questionnaires (such as treat-
Complementary and alternative approaches, in- ment response), patient-reported and intermediate
cluding acupuncture and Chinese herbal medicine, sleep outcomes, and harms.
have also been used to treat insomnia. Grading the Evidence and Developing
Recommendations
GUIDELINE FOCUS AND TARGET POPULATION This guideline was developed by the ACP Clinical
The purpose of this American College of Physicians Guidelines Committee according to the ACP guideline
(ACP) guideline is to present recommendations based development process, details of which can be found in
on the evidence on the efficacy, comparative effective- the ACP methods paper (14). The Clinical Guidelines
ness, and safety of treatments for chronic insomnia dis- Committee used the evidence tables in the accompa-
order. The target audience for this guideline includes nying systematic review and full report (11, 12) when
all clinicians, and the target patient population includes reporting the evidence and graded the recommenda-
all adults with chronic insomnia disorder. These recom- tions by using the ACP system, which is based on the
mendations are based on 2 background evidence re- GRADE (Grading of Recommendations Assessment,
view papers (11, 12) and an evidence review sponsored Development and Evaluation) approach (Table).
by the Agency for Healthcare Research and Quality Peer Review
(AHRQ) (13). The AHRQ evidence review was sent to invited
peer reviewers and posted on the AHRQ Web site for
METHODS public comments. The guideline was peer reviewed
Systematic Review of the Evidence through the journal and was posted online for com-
The evidence review was conducted by the ments from ACP Regents and Governors, who repre-
AHRQ's Minnesota Evidence-based Practice Center. sent physician members at the national level.
The summary of methods for the evidence review is
provided in the Appendix (available at www.annals BENEFITS OF TREATMENTS FOR CHRONIC
.org), and additional details are included in the accom- INSOMNIA DISORDER
panying background evidence review papers (11, 12)
The efficacy, safety, and comparative effectiveness
and the full evidence report (13). Reviewers searched
of psychological and pharmacologic treatments for
several databases for randomized, controlled trials
chronic insomnia disorder are summarized in Appendix
(RCTs) published in English from 2004 through Sep-
Tables 2 to 5 (available at www.annals.org) and in the
tember 2015. The study population included adults
accompanying evidence reviews (11, 12). Evidence is
(aged ≥18 years) with chronic insomnia disorder (in-
described for the general adult population as well as
somnia definitions that match diagnostic criteria for in-
for older adults (aged >55 years).
somnia disorder).
The systematic evidence review evaluated psycho- Psychological Treatment
logical therapies, including CBT-I, multicomponent be- Evidence for most psychological therapies was lim-
havioral therapy or BBT for insomnia, stimulus control, ited, and there was insufficient evidence to determine
relaxation strategies, and sleep restriction; pharmaco- the comparative effectiveness of different psychologi-
logic therapies, including doxepin, triazolam, estazo- cal treatments for chronic insomnia disorder in the gen-
lam, temazepam, flurazepam, quazepam, zaleplon, zol- eral population or in older adults.
126 Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 www.annals.org
Data from observational studies suggest that seri- term use of medications, to decide whether to add
ous adverse effects, such as dementia and fractures, pharmacological therapy in adults with chronic insom-
may be associated with hypnotic drugs (74, 75). Prod- nia disorder in whom cognitive behavioral therapy for
uct labels from the FDA warn patients about cognitive insomnia (CBT-I) alone was unsuccessful. (Grade: weak
and behavioral changes, such as possible driving im- recommendation, low-quality evidence)
pairment and motor vehicle accidents, as well as other Benefits of pharmacologic treatment include im-
adverse effects. The FDA also recommends lower proved sleep outcomes, such as sleep onset latency
doses of benzodiazepine and nonbenzodiazepine hyp- and total sleep time, and in some cases improved
notics in women and in older or debilitated adults. In global outcomes in the general population and in older
addition, the FDA recommends short-term use of these adults. Most studies have examined newer medica-
drugs, although many patients may continue their use tions, whereas commonly used older and generic med-
for extended periods. ications, such as diphenhydramine and trazodone,
have not been studied. Low-quality evidence showed
Comparative Safety of Pharmacologic
that both eszopiclone and zolpidem improved global
Treatments
outcomes in the general population, and low- to
Evidence was generally insufficient to determine
moderate-quality evidence showed that eszopiclone,
the comparative safety of various pharmacologic
zolpidem, and doxepin improved sleep outcomes,
treatments.
such as sleep onset latency, total sleep time, and wake
The Figure summarizes the recommendations and
after sleep onset. Moderate-quality evidence showed
clinical considerations.
that suvorexant, an orexin antagonist recently ap-
proved by the FDA, improved treatment response and
sleep outcomes in mixed general and adult popula-
RECOMMENDATIONS tions. Low-quality evidence showed no statistically sig-
Recommendation 1: ACP recommends that all adult nificant difference between ramelteon and placebo for
patients receive cognitive behavioral therapy for insom- sleep outcomes in the general population.
nia (CBT-I) as the initial treatment for chronic insomnia In older adults, low-quality evidence showed that
disorder. (Grade: strong recommendation, moderate- eszopiclone improved global and sleep outcomes and
quality evidence) both zolpidem and ramelteon decreased sleep onset
Cognitive behavioral therapy for insomnia consists latency. Moderate-quality evidence showed that dox-
of a combination of treatments that include cognitive
epin improved ISI scores, and low- to moderate-quality
therapy around sleep, behavioral interventions (such as
evidence showed that it improved sleep outcomes.
sleep restriction and stimulus control), and education
Evidence was insufficient for melatonin in the gen-
(such as sleep hygiene). It can be performed in primary
eral population and in older adults. Benzodiazepines,
care (18, 19). There are various delivery methods for
although widely used, were not addressed in this
CBT-I, such as individual or group therapy, telephone-
guideline because few studies met the inclusion criteria
or Web-based modules, or self-help books. Most stud-
of the systematic review (insufficient evidence).
ies focused on in-person CBT-I; however, the data sug-
gest that other delivery methods are also effective. Evidence on harms was limited from RCTs that met
Cognitive behavioral therapy for insomnia should the inclusion criteria for the review, which mostly re-
be considered first-line treatment for adults with ported on study withdrawals. However, observational
chronic insomnia disorder. Although the current evi- studies have shown that hypnotic drugs may be associ-
dence is insufficient to show the harms associated with ated with infrequent but serious adverse effects, such
behavioral interventions, any such harms are likely to as dementia, serious injury, and fractures (74, 75, 76,
be mild. Moderate-quality evidence showed that CBT-I 77). In addition, FDA labels warn of daytime impair-
improved global outcomes in the general population, ment, “sleep driving,” behavioral abnormalities, and
including increased remission and treatment response worsening depression. The FDA suggests dosages
and reduced ISI and PSQI scores compared with con- lower than those used in many of the included studies,
trols. Moderate-quality evidence showed that CBT-I especially for older adults.
also improved sleep outcomes in the general popula- Evidence is insufficient to evaluate the balance of
tion, including reduced sleep onset latency and wake the benefits and harms of long-term use of pharmaco-
after sleep onset and improved sleep efficiency and logic treatments in adults with chronic insomnia disor-
sleep quality. Low- to moderate-quality evidence der. The FDA has approved pharmacologic therapy for
showed that CBT-I also improved global and sleep out- short-term use (4 to 5 weeks), and patients should not
comes in older adults, including improved PSQI and ISI continue using the drugs for extended periods. The
scores, reduced sleep onset latency, and improved FDA also recommends that patients with insomnia that
sleep efficiency. Moderate-quality evidence showed does not remit within 7 to 10 days of treatment should
that CBT-I reduced wake after sleep onset in older be further evaluated.
adults. There was insufficient evidence overall on the com-
Recommendation 2: ACP recommends that clini- parative effectiveness and safety of the various pharma-
cians use a shared decision-making approach, including cologic treatments. See Appendix Tables 4 and 5 for a
a discussion of the benefits, harms, and costs of short- summary of efficacy, adverse events, and costs for
128 Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 www.annals.org
Figure. Summary of the American College of Physicians guideline on management of chronic insomnia disorder in adults.
Summary of the American College of Physicians Guideline on Management of Chronic Insomnia Disorder in Adults
Sleep outcomes (patient-reported): SOL, number of awakenings, WASO, TST, sleep efficiency (total sleep time / total time in
bed), sleep quality
Adverse effects
Study withdrawals
Benefits General Population
Psychological
CBT-I: improved remission, treatment response, PSQI (2.1 points) and ISI (4.8 points) scores, SOL (11.6 min), WASO
(21.4 min), sleep efficiency, sleep quality
Pharmacologic
Eszopiclone: improved remission, ISI scores (4.6 points), SOL (19.1 min), TST (44.8 min), WASO (10.8 min)
Zolpidem “as needed”: improved CGI, SOL (14.8 min), TST (48.1 min)
Zolpidem extended-release: improved CGI, SOL (9 min), TST (25 min), WASO (16 min)
Suvorexant: improved treatment response, ISI score (1.2 points), SOL (6.0 min), TST (16.0 min), WASO (4.7 min)
Doxepin: improved TST (11.9 min for 3 mg, 17.3 min for 6 mg), WASO (10.2 min for 3 mg, 14.2 min for 6 mg)
Older Adults
Psychological
CBT-I: improved PSQI (3.0 points) and ISI (3.6 points) scores, SOL (8.2 min), WASO (37.6 min), sleep efficiency
Multicomponent behavioral therapy/BBT: improved SOL (10.4 min), WASO (14.9 min), sleep efficiency, sleep quality
Pharmacologic
Eszopiclone: improved remission, ISI score (2.3 points), TST (30.0 min), WASO (21.6 min)
Doxepin: improved ISI score (1.7 points), SOL (14.7 min), TST (23.9 min), WASO (17.0 min)
Insufficient evidence
www.annals.org Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 129
Figure—Continued
Harms Psychological: sparsely reported but likely small because of noninvasive nature of therapy
Benzodiazepines
Increased risk for falls, hip fractures, and mobility problems in older adults
Nonbenzodiazepines
Eszopiclone: somnolence, unpleasant taste, myalgia, memory impairment, psychiatric-related adverse effects, depression,
anxiety, accidental injury
Zolpidem: anxiety, somnolence, mood alterations, hallucinations, depression, psychiatric-related adverse events, memory
and driving impairment, risk for fractures or major head injury or fracture requiring hospitalization, increase in incident
cancer cases
Suvorexant: somnolence; cognitive and behavioral changes, such as amnesia, anxiety, hallucinations, and other
neuropsychiatric symptoms; complex behaviors, such as “sleep-driving”; worsening of depression, including suicidal
thinking in persons with depression; daytime impairments; sleep paralysis; hypnagogic/hypnopompic hallucinations
Ramelteon: dizziness; somnolence (similar to placebo); fatigue; headache; unpleasant taste; nausea; new cognitive or
behavioral abnormalities; complex behaviors, such as “sleep-driving”; exacerbation of depression and suicidal ideation in
primarily depressed patients
Doxepin: sedation, fatigue, weakness, lethargy, dry mouth, constipation, blurred vision, headache
Infrequent but serious adverse events, such as fractures and dementia, have been reported for hypnotic drugs in
observational studies. FDA label warnings include daytime impairment, “sleep driving,” behavioral abnormalities, and
worsening depression in depressed patients.
Recommendation 2: ACP recommends that clinicians use a shared decision-making approach, including a discussion of the
benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with
chronic insomnia disorder in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (Grade: weak
recommendation, low-quality evidence)
Clinical Considerations Medications should ideally be used for no longer than 4 to 5 wk, and the skills learned in CBT-I can manage insomnia over the
longer term.
Studies of chronic insomnia disorder typically excluded patients with insomnia due to another disorder. Before recommending
that patients continue use of insomnia medications, clinicians should consider treatable secondary causes of insomnia, such as
depression; pain; benign prostatic hypertrophy; substance abuse disorders; and other sleep disorders, such as sleep apnea and
restless legs syndrome.
If, after a trial of CBT-I, a shared decision is made to continue medications for longer than 4 to 5 wk, clinicians should revisit the
need for medication continuation at periodic intervals.
Chronic insomnia disorder itself may have deleterious health effects. However, whether medications decrease the harmful health
effects of sleep deprivation is unknown, and evidence is insufficient to assess the balance of benefits and harms from long-term
use of medications.
Older adults can be more sensitive to medications and their adverse effects and should be monitored closely when treated with
pharmacologic agents.
BBT = brief behavioral therapy; CBT-I = cognitive behavioral therapy for insomnia; CGI = Clinical Global Impression Scale; FDA = U.S. Food and
Drug Administration; ISI = Insomnia Severity Index; PSQI = Pittsburgh Sleep Quality Index; RCT = randomized, controlled trial; SOL = sleep onset
latency; TST = total sleep time; WASO = wake after sleep onset.
pharmacologic treatments and the Figure for clinical behavioral interventions or BBT, sleep restriction, stim-
considerations. ulus control, or relaxation therapy on global outcomes
in the general population or in older adults with chronic
AREAS WITH INSUFFICIENT EVIDENCE insomnia disorder. There was also insufficient evidence
For nonpharmacologic therapy, evidence was in- to determine the effect of sleep restriction or relaxation
sufficient to determine the effect of multicomponent therapy on sleep outcomes in these populations.
130 Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 www.annals.org
www.annals.org Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 131
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132 Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 www.annals.org
www.annals.org Annals of Internal Medicine • Vol. 165 No. 2 • 19 July 2016 133
Treatment Description
Stimulus control Behavioral treatment that aims to establish consistency in sleep patterns and maintain an association of
sleep with the bed and bedroom (e.g., only go to sleep when tired)
Sleep restriction Behavioral intervention that limits time in bed to sleep time, gradually increasing the time spent in bed
as sleep efficiency improves
Relaxation training Training to reduce somatic tension and control bedtime thought patterns that impair sleep
Cognitive behavioral therapy for insomnia Combination treatments that include cognitive and behavioral components, including stimulus control,
sleep restriction, and sometimes relaxation training
Multicomponent therapy or brief Multicomponent behavioral therapies without cognitive therapy
behavioral therapy for insomnia
* Adapted from reference 13.
Appendix Table 2. Efficacy and Safety of Psychological Treatments for Chronic Insomnia Disorder in All Adults*
Appendix Table 3. Efficacy and Safety of Psychological Treatments for Chronic Insomnia Disorder in Older Adults*
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Appendix Table 4—Continued
Outcome Direction of Effect Quality of Data AEs Cost of Medication (30-d
Evidence Supply)
Comparative effectiveness
Zolpidem (5–10 mg) vs. temazepam (15–20 mg)
Total sleep time Improved Low MD, 27.0 (CI, 2.1 to 51.9) NA NA
Zaleplon (5–20 mg) vs. zolpidem (10 mg)
Study withdrawals NS Low RR, 1.0 (CI, 0.7 to 1.5) NA NA
>1 AE NS Moderate RR, 0.95 (CI, 0.9 to 1.03)
AE = adverse effect; ER = extended-release; ISI = Insomnia Severity Index; MD = mean difference; NA = not applicable; NR = not reported; NS = not statistically significant; RR = relative risk;
WMD = weighted mean difference; SIADH = syndrome of inappropriate antidiuretic hormone secretion.
* Cost data were taken from the Healthcare Bluebook. Specific AEs associated with each drug were derived from the Evidence-based Practice Center report when available and from Medscape
(limited to those with reported frequencies >1% where the frequencies were available [suvorexant, zaleplon, zolpidem]).
† Mixed population of general and older adults.
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