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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_41_библиотеки_им_акад_М_И_Перельмана

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disorder is characterized by poor sleep, with daytime consequences, that persists for 3months and occurs at least three times per week. Per the ICSD-3, a diagnosis of chronic insomnia requires that a patient report sleep disturbance for at least 3months, with short-term insomnia characterized by sleep disturbance that is less than 3 months in duration [5]. Consequences associated with sleep disturbance include increased risk for other medical and mental health comorbidities, lost pro­ductivity and increased absenteeism, and increase risk for accident, injury, and death [6].
Given the prevalence of and impairment associated with poor sleep, interven­tions have been developed to treat the symptoms of insomnia disorder [2, 7, 8]. Interventions include both behavioral (i.e., non-medication) treatments and medica­tion treatments. This chapter describes the best practices for the treatment of insom­nia disorder. Based on the AASM Clinical Practice Guidelines [8], Fig. 13.1 describes a decision-making framework for the treatment of insomnia disorder. Evidence-based treatments, patients’ preferences, sleep disorder comorbidities, and treatment responses will inform decision-making. The following sections describe the treatments included in this framework and factors that may inuence treatment delivery and referral.
Does the patient meet
diagnostic criteria for
insomnia disorder?
No
Evaluate for other sleep
disorders and refer for
sleep study if not
previously conducted
Pratice or refer to
CBT-I
Treatment Response
Evaluate for other sleep
disorders and refer for
previously conducted
treatments for insomnia
NoYesNoYes
Non-Response
sleep study if not
Implementation of
other behavioral
Practice or
refer to CBT-I
Treatment Response
Evaluate for other sleep
disorders and refer for
sleep study if not
previously conducted
Treatment
Non-Response
Consdier implementation
of other behavioral
treatments for insomnia
Are they interested in
behavioral treatment?
Provide medication with
lowest risk or refer to
prescriber
Yes
Continue treatment for
comorbid condition and
refer to CBT-I
Yes
Were there previous attempts to treat this
condition(s)?
Yes
Was there a treatment
response?
Evaluate for other sleep
disorders and refer for
previously conducted
Are there comorbid
conditions that can be
treated simultaneously?
No
Pratice or refer to CBT-
I and implement
treatment for comorbid
conditions
No
sleep studt if not
Supplement
with medication
as needed
Fig. 13.1 Treatment decision-making framework for the treatment of insomnia disorder
Treatment
Consider
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Behavioral Interventions
Cognitive behavioral therapy for insomnia The rst line treatment for insomnia
is cognitive behavioral therapy for insomnia (CBT-I) [7]. The AASM Clinical Practice Guidelines strongly recommend clinicians use multicomponent CBT-I for the treatment of chronic insomnia disorder in adults [9]. A “strong recommenda­tion” indicates that clinicians should implement or refer to this treatment under most circumstances. A “conditional” recommendation indicates that clinicians should consider knowledge of the patient (i.e., patient values and preferences) and clinical knowledge and experience to determine the best intervention. While multi­component CBT-I is strongly recommended, individual components of CBT-I are also conditionally recommended for the treatment of chronic insomnia disorder in adults. The following sections will describe the components of CBT-I.
The “3-Ps” model underlies the rationale for CBT-I. This model proposes that insomnia develops from and is maintained by predisposing factors, precipitating factors, and perpetuating factors [10]. Predisposing factors increase an individual’s risk of developing insomnia (e.g., family history of sleep disorders). Precipitating factors include circumstances or events that lead patients to experience clinically signicant sleep difculties (e.g., injuries/medical conditions, interpersonal events) [11]. Attempts to cope with precipitating factors can lead to perpetuating factors (e.g., compensatory daytime napping, prolonged time awake in bed at night, caf­feine use during that day). According to the 3-Ps model, perpetuating factors lead to chronic insomnia [10]. Insomnia is maintained by the interrelations among prob­lematic emotions, thoughts, and behaviors. Patients can develop anxiety or other emotions regarding their sleep difculties, experience inaccurate and unhelpful thoughts about their sleep difculties, and engage in maladaptive behaviors to cope with difculties initiating and maintaining sleep [12, 13]. CBT-I intervenes on this problematic cycle by changing problematic behaviors and thoughts [8]. CBT-I ses­sions typically incorporate the following intervention components: (1) stimulus control, (2) sleep restriction, (3) sleep hygiene recommendations, (4) relaxation strategies, and (5) cognitive therapy exercises. Of these components, the strongest evidence supports stimulus control and sleep restriction as stand-alone treatments, while evidence for the other components remains more modest [14, 15].
Stimulus control
Stimulus control is a behavioral phenomenon that underlies mul-
tiple behaviors, including sleep [16]. In basic terms, sleep is considered an instru­mental behavior, and cues (or stimuli) in a patient’s environment provide information about whether sleep will be reinforced or not [17, 18]. Example of discriminative stimuli for sleep include darkness/nighttime or being in bed. However, if these stim­uli are inconsistently paired with sleep, difculty sleeping may be the result of inad­equate discriminative stimulus control. Patients who undergo CBT-I are provided with education about classical and operant conditioning to ensure they understand the rationale for stimulus control therapy [19]. The provider and patient discuss the associations that can develop between the bed (i.e., place of sleep) and anxiety and/
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or other non-sleep behaviors/activities and how these associations lead to condi­tioned insomnia [14]. The intervention of stimulus control involves using the sleep area only for sleeping, refraining from doing other activities in the sleep area, and avoiding sleeping in areas other than the designated sleep area. Per the AASM Clinical Practice Guidelines, it conditionally recommended that clinicians imple­ment stimulus control as a single-component therapy for the treatment of insomnia disorder.
Sleep restriction In addition to stimulus control, patients are oriented to the ratio­nale for tracking sleep. Behavior monitoring is a common component of many behavioral therapies [20]. Patients are oriented to the sleep diary and are asked to complete a weekly sleep diary, which includes daily bedtimes, sleep onset latencies, wake times after sleep onset, number of nighttime awakenings, rise times, and day­time awakenings (see Fig.13.2 for an example of sleep diary information). Based on data on the sleep diary, patients are oriented to the concept of sleep efciency. Sleep efciency is calculated by dividing total sleep time by total time in bed (min­utes from bedtime to rise time) and converting the quotient to a percentage. Patients and providers discuss how low sleep efciency can exacerbate problematic associa­tions between bed and wakefulness, maintaining insomnia symptoms [15]. Patients may develop inaccurate beliefs that more time in bed provides a greater opportunity for sleep. In fact, excessive time in bed not sleeping can further contribute to inad­equate stimulus control. Sleep restriction involves reducing the amount of time a patient spends in bed in an effort to improve sleep efciency [18, 21]. This involves setting a sleep window based on a patient’s sleep diary total time in bed. Patients are
Day 1
Morning questions
1. What time did you got to bod last night?
2. How long did it take you to fall asleep last night?
3. Did you wake up during the night last night?
a. If yes, How many times did you wake up?
b. If yes, What was the total amount of time that you wereawake?
4. Last night, did you take any medication to help you sleep?
a. If yes, What did you take? (write down any sleep aid below)
b. What time did you take this?
5. What time did you wake up for the last time this morning?
6. This morning, what time did you get up for the day?
Fig. 13.2 Example of information collected in sleep diary
___:___ am/pm
minutes
No Yes
times
minutes
No Yes
___:___ am/pm
___:___ am/pm
___:___ am/pm
Bedtime questions
7. Did you take any naps or doze off at any time today before getting into bed for the night?
a. If yes, How many times did you spend napping or dozing?
8. Did you drink any beverages containing caffeine today?
a. If yes, About how many cups or glasses?
b. If yes, What time did you have your last one?
9. Did you drink any beverages containing alcohol today?
a. If yes, About how many drinks did you have?
(Please refer to the “Drink Conversion Table” on the inside back cover)
b. What time did you have your last drink?
10. Did you remove the sleep watch for any reason today?
a. If yes, what time?
Time off ____:____ am/pmTime on: ____:____ am/pm
b. Reason removed ______________________________________
No
minutes
No Yes
___ cups/glasses
___:___ am/pm
No Yes
_________ drinks
___:___ am/pm
No Yes
Yes
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instructed to only sleep within this window of time (i.e., between prescribed bed­time and rise time). Patients should not go to bed earlier than their prescribed bed­time or wake up later than their prescribed rise time, and should avoid napping outside of their sleep window [15, 22]. It is conditionally recommended that provid­ers implement sleep restriction as a single-component treatment for insomnia dis­order [9].
Sleep hygiene recommendations CBT-I providers present information about day­time and nighttime activities that can help or hinder good sleep. Patients receive information about how factors (e.g., light exposure, alcohol/substances, medica­tions, caffeine, food intake, and exercise) can impact wakefulness and sleepiness [23]. The patient and provider also discuss the sleep environment and what environ­mental factors can help or hinder sleep (e.g., temperature, noise, light, bodily dis­comfort, bed partner, etc.). The patient and provider discuss changes the patient can implement to improve their sleep [23]. Sleep hygiene education, as a standalone intervention, has been shown to be less effective than multicomponent CBT-I [24]; however, sleep hygiene is conditionally recommended as a single-component treat­ment for insomnia disorder [8].
Relaxation strategies Anxiety and hyperarousal at bedtime serve as barriers to sleep initiation. CBT-I providers educate patients about the problematic relation­ships among thoughts, emotions, and sleep behaviors that occur in the context of insomnia. The goal of relaxation strategies in the context of insomnia is to reduce hyperarousal at bedtime. Consistent with the principle of counter-conditioning, an undesired response (i.e., arousal) is reduced as the stimulus (i.e., place of sleep) is consistently paired with a more desired response (i.e., relaxation) [25]. Relaxation strategies, including breathing exercises [26] and progressive muscle relaxation [27], are often presented as part of CBT-I protocols [28]. Additionally, patients are encouraged to implement a relaxing bedtime routine (i.e., buffer zone) each night in an effort to (1) reduce anxious thoughts at bedtime [22] and (2) weaken the associa­tion between hyperarousal and bedtime that may have developed due to poor sleep habits. Relaxation therapy is conditionally recommended as a single-component treatment for insomnia disorder [8].
Cognitive therapy techniques
incorporates cognitive techniques to challenge unhelpful and inaccurate thoughts that lead to problematic sleep behavior (i.e., “I have to go to bed early, and then I will sleep more tonight”) [29]. To identify and adapt problematic thoughts related to sleep, providers will utilize Socratic questioning [30]. Additionally, providers may ask patients to examine their thoughts by looking at their sleep diary data (i.e., “Do you actually sleep more if you spend more time in your bed?”) or encourage patients to test these thoughts by engaging in a behavioral experiment. Sleep diary informa­tion can also help to challenge inaccurate or problematic thoughts about daytime functioning (e.g., “If I don’t get eight hours of sleep, I will not be able to function the next day”). By providing evidence to the contrary regarding the relationship
As a form of cognitive behavioral therapy, CBT-I
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between total sleep time and daytime functioning, data gathered during CBT-I ses­sions can lessen anxiety about sleep difculties and the perceived consequences of insomnia. Additionally, cognitive techniques can be used if patients express reluc­tance to engage in other components of CBT-I (e.g., sleep restriction). Other cogni­tive techniques include but are not limited to (1) evaluating the evidence for or against a thought, (2) exploring alternative explanations or interpretation, (3) and/or presenting new information to patients [31].
Multiple meta-analyses have demonstrated the effectiveness of CBT-I at improv­ing wake/sleep patterns among patients with insomnia, including patients with comorbid medical and psychiatric conditions [28, 32, 33]. The intervention compo­nents of CBT-I and their implementation are described in Table13.1. It should be noted that the delivery of CBT-I is individualized for each patient, with the empha­sis and timing of each intervention component depending on the clinical presenta­tion of each individual patient.
Individual format CBT-I interventions have been most commonly studied using a one-on-one, in person therapy format [28, 32]. Most protocols consist of four to six, 60-minute sessions with a trained CBT-I provider. However, CBT-I has also been delivered using telemedicine platforms, with high feasibility and acceptability reported by patients and providers [34]. Meta-analyses have consistently found individual-based CBT-I to be an effective treatment for insomnia symptoms [32,
33]. As previously stated, the multicomponent, individual-based form of CBT-I is
strongly recommended by the AASM Clinical Practice Guidelines for the Treatment of Insomnia [8]. This means that under most circumstances (or when possible), providers should refer patients to or implement individual-based CBT-I [8].
Group format Despite the efcacy of this intervention, we recognize that there are circumstances when one-on-one CBT-I may not be readily available or acces­sible to patients [35]. Fortunately, there is also research demonstrating the efcacy for group-based CBT-I, though there is less evidence for group-based CBT-I com­pared to one-on-one CBT-I [36]. This form of CBT-I involves providing psycho­education about sleep, including the rationales for stimulus control, sleep restriction, and the other intervention components of CBT-I to a group of patients [37]. Each patient tracks their sleep using a sleep diary, and sleep windows are prescribed to each patient based on individual data from patients’ respective sleep diaries.
Telehealth
Telehealth modalities have been used to deliver CBT-I in several stud-
ies and can increase access to treatment for patients with insomnia disorder who many nd it difcult to travel to in-person sessions or to navigate a self-guided treatment without provider support. There is evidence that CBT-I can be delivered via telehealth in both individual and group format, and it is non-inferior to in-person delivery [38, 39]; however, there are challenges to group delivery including privacy consideration and technological challenges.
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Table 13.1 Typical intervention components of cognitive behavioral therapy for insomnia (CBT-I)
Topics covered Session activities Homework
Getting started with CBT-I (sleep education, sleep hygiene, and stimulus control)
Sleep education: sleep regulation, insomnia (3P model), sleep stages and macrostructure Introduce stimulus control concepts Lifestyle habits that enhance or hinder sleep Introduce and explain daily sleep diary
Scheduling sleep (sleep restriction therapy)
Learn about the homeostatic and circadian sleep processes Introduce sleep restriction
Thoughts about sleep (cognitive therapy)
Adjust time in bed Discuss validity and utility of unhelpful sleep-related thoughts
CBT-I: progress and obstacles (cognitive therapy)
Adjust time in bed Review progress and obstacles Use cognitive strategies to address barriers to adherence
CBT-I: sleeping well over the long-term (relapse prevention)
Adjust time in bed Discuss relapse prevention and coping
Discuss classical conditioning and insomnia Action plan: sleep hygiene changes, stimulus control
Review/discuss sleep diary Action plan: daily sleep schedule
Review/discuss sleep diary Action plan: revise sleep schedule, develop coping cards
Review/discuss sleep diary Addressing barriers and obstacles using cognitive­therapy methods Action plan: identify obstacles and strategies to address them
Review/discuss sleep diary Action plan for relapse prevention
Implement action plan (sleep hygiene practices, stimulus control) Daily sleep diary
Implement action plan (sleep schedule) Daily sleep diary
Implement action plan (sleep schedule, coping cards) Daily sleep diary
Implement action plan (sleep schedule, strategies to address obstacles) Daily sleep diary
Use tools/skills for future sleepless nights
281
Self-guided formats To increase access to CBT-I, online, self-guided protocols and CBT-I informed apps have been developed. Evidence-based examples include the Veteran Health Administration’s (VHA) “Path to Better Sleep” [40] and “CBT-I Coach.” [41] Online behavioral interventions for insomnia have been shown to improve sleep outcomes [42–44]. There is also evidence that face-to-face CBT-I is more effective than guided online interventions [45]. That being said, CBT-I provid­ers report using CBT-I Coach when delivering one-on-one CBT-I, and research demonstrates that the app is viewed favorably by patients [46, 47]. It should be noted that use of CBT-I Coach or other apps alone is not comparable to the delivery of CBT-I by a trained provider.
Brief behavioral treatment for insomnia Given that stimulus control and sleep restriction are the intervention components of CBT-I with the strongest evidence,
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brief behavioral treatment for insomnia (BBT-I) was derived from CBT-I.BBT-I is shorter than CBT-I [48, 49], typically involving four sessions, and focuses on help­ing patients to make behavioral changes to improve their sleep. BBT-I provides education about homeostatic (i.e., sleep drive) and circadian drives (i.e., biological clock) and how waking behaviors associated with insomnia disorder can interfere with these processes [50]. Similar education is provided in CBT-I protocols as well [22]. Intervention components of BBT-I include (1) sleep restriction to increase sleepiness at the prescribed bedtime, (2) stimulus control to reduce time spent awake in bed, (3) adherence to prescribed bedtimes and rise times, (4) and elimina­tion/reduction of bad sleep hygiene behaviors and promotion of good sleep hygiene behaviors. BBT-I encourages patients to modify waking behaviors to normalize homeostatic and circadian drives. BBT-I does not target sleep-related thoughts and does not incorporate cognitive strategies [50]. While CBT-I remains the rst line treatment for insomnia disorder, a recent noninferiority clinical trial found no sig­nicant differences between BBT-I and CBT-I on sleep-related outcomes [51]. The AASM Clinical Practice Guidelines recommend that providers may use multicom­ponent brief therapies for insomnia [9].
Consistent with CBT-I, patients who undergo BBT-I complete a sleep diary each week, which guides treatment recommendations. If a patient’s sleep onset latency is >20minutes, it is recommended they leave their sleeping area and engage in a low­stimulating activity until they are sleepy, at which point they are instructed to return to bed. Generally, if a patient is taking >30minutes to fall asleep or they are awake >30minutes after sleep onset, it is recommended that the patient reduce their time in bed by 15minutes. Alternatively, if the patient is taking <30minutes to fall asleep or they are awake <30minutes after sleep onset, it is recommended that the patient increase their time in bed by 15minutes [22, 50]. This is known as the 30/30 rule in BBT-I [50, 52].
Due to the high incidence and persistence of untreated insomnia [53], an impor­tant part of both CBT-I and BBT-I is relapse prevention. Patients are encouraged to consider the strategies they have learned in insomnia treatment and to identify a plan for how they will intervene on their own behavior in the future should they have trouble initiating or maintaining sleep again. A recent meta-analysis showed the effects of CBT-I remain signicant a year after therapy [54]. The focus on relapse prevention in the termination session highlights the importance of patient education in both CBT-I and BBT-I, ensuring that patients understand the treatment rationales and develop a sense of agency regarding their sleep.
Novel behavioral approaches
efcacy and effectiveness of CBT-I, challenges with treatment completion remain. Estimates of treatment dropout in clinical settings range from 13.7% to 34.0% [55,
56]. Shorter total sleep time and greater depression symptoms at baseline predict
treatment attrition in clinical trials of CBT-I.Adherence challenges have also led practitioners and researchers to explore adaptations of CBT-I [57]. Mindfulness and acceptance-based approaches (so-called third-wave cognitive behavioral therapies)
Despite the body of research demonstrating the
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are receiving growing attention. Kabat-Zinn (1994) dened mindfulness as “paying attention in a particular way: on purpose, in the present moment, and nonjudgmentally” (p.4) [58]. Components of mindfulness (e.g., present moment awareness, observa­tion, description) have been incorporated into cognitive behavioral therapies, with the goal of noticing thoughts, rather than challenging or changing said thoughts [59].
Mindfulness-based Ong etal. (2012) proposed a model of insomnia consist with
third-wave approaches. The model suggests that sleep-related arousal is caused rst by sleep difculties and their consequences, and then the arousal is exacerbated by “meta-cognitive” factors, such as distress about concerns regarding the insomnia [60]. Addressing meta-cognitive factors may improve the general effectiveness of treatment and reduce non-adherence through increased tolerance of discomfort [60]. Mindfulness-based therapy for insomnia (MBTI) incorporates (1) experiential mindfulness practices (e.g., body scan, sitting meditation), (2) education about mindfulness, and (3) behavioral strategies to improve insomnia (i.e., stimulus con­trol, sleep restriction, and targeted sleep hygiene recommendations). Similar to CBT-I and BBT-I, patients undergoing MBTI are asked to keep a sleep diary, but they are also asked to keep a meditation diary [61]. MBTI has been found to be effective at improving insomnia symptoms [62].
Acceptance-based A third-wave cognitive behavioral therapy that incorporates
mindfulness is Acceptance and Commitment Therapy (ACT) [63, 64]. CBT and ACT have similarities and distinct differences. Both emphasize the role of cognition in psychopathology, but each model proposes different mechanisms of change [65]. In CBT, adaptive changes in thoughts and behaviors contribute to therapeutic change [66]. The ACT model suggests that thoughts do not directly cause problem­atic behaviors and a decrease in dysfunctional thoughts is not a prerequisite for therapeutic change [67]. Therapeutic change occurs by changing the relationship one has with “dysfunctional thoughts” through contacting the present moment, and, based on what that situation affords, acting in accordance with one’s chosen values. This process is referred to as psychological exibility [64].
Within the ACT framework, there are six interrelated processes which promote psychological exibility including (1) present moment awareness, (2) acceptance of current experience, (3) self as context (i.e., non-identication with thoughts), (4) cognitive defusion (i.e., creating “space” between self and thoughts), (5) values (i.e., activities that give lives meaning), and (6) committed actions (i.e., behaviors in service of these values) [63, 64]. While ACT has been used to treat multiple psychi­atric conditions and improve distress among individual with multiple comorbid medical conditions, few studies have examined insomnia as a primary outcome variable [68]. However, there was a recent meta-analysis that examined the impact of ACT on insomnia and sleep quality, and ndings indicated that engagement in ACT was associated with improved sleep outcomes [69]. While case studies and developmental study ndings for ACT-based insomnia treatment are promising [70,
71], additional clinical trials are needed.
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Behavioral Treatment forInsomnia: Safety Considerations
The risks associated with participation in CBT-I or other behavioral treatments for insomnia are minimal [8]. However, there are times when sleep restriction is contra­indicated. For instance, if a patient has a history of bipolar disorder, disruptions to the sleep schedule can trigger hypomanic/manic symptoms [72, 73]. Generally, it is not recommended that providers prescribe a sleep window less than 5hours [22], even when patients are reporting total sleep time of less than 5hours. BBT-I guide­lines recommend a sleep window of no less than 6hours [50]. CBT-I providers and patients should also discuss the utility of sleep outside of the prescribed sleep win­dow when patients are sleepy and they must engage in activities where sleep depri­vation is dangerous (e.g., driving).
Additionally, while CBT-I has been shown to be effective at treating insomnia in patients with comorbid sleep conditions, assessment of sleep disorders (e.g., obstructive sleep apnea [OSA], restless leg syndrome) [8, 74, 75] is recommended prior to initiation of behavioral insomnia treatment. This ensures that patients receive treatments for their other sleep disorders (e.g., continues positive airway pressure [CPAP], medications/supplements) and optimizes the effectiveness of behavior treatments for insomnia. Research has also shown that participation in CBT-I increases CPAP use in patients with comorbid insomnia and OSA [76]. Finally, research has demonstrated that insomnia is a risk factor for suicidal ideation [77, 78]. While research has shown CBT-I and attendance of sleep medicine appoint­ments reduces depression symptoms and lowers risk of suicide [79, 80], risk assess­ment and safety planning should be conducted prior to initiating CBT-I with patients to ensure that patients are not a harm to themselves or others.
Behavioral Treatments forInsomnia: Considerations forSpecial Populations
Since insomnia disorder is highly comorbid with a variety of medical and mental health disorders [3, 81], special considerations should be made with some patients. Providers should involve caregivers when patients with insomnia present with cog­nitive impairment or are dependent on caregivers to complete activities of daily living. Caregivers may also benet from components of CBT-I to both optimize their sleep and caregiving abilities [82]. Additionally, patients with limited mobil­ity or pain may require modication to traditional stimulus control recommenda­tions. Understanding the unique factors that contribute to nighttime awakenings (e.g., pain, need to urinate, hot ashes) is critical in developing effective behavioral treatment plans [3, 83, 84]. Patients with psychiatric comorbidities may require greater emphasis on interventions for problematic thoughts related to sleep and avoidance of sleep (e.g., patients with posttraumatic stress disorder [PTSD] may avoid sleep due to fear of nightmares) [85]. Finally, for a patient to be diagnosed
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with insomnia, the patient must report sleep problems, despite having the opportu­nity to sleep [4]. This differentiation is important when assessing patients who may not have a consistent opportunity to sleep (e.g., parents of infants) and/or patients who do not have a consistent/safe place to sleep (i.e., individual with unstable housing). In these circumstances, it may be best to delay initiation of behavioral treatments for insomnia and rst address barriers to consistent and safe opportuni­ties for sleep.
Medication Treatments forInsomnia
While CBT-I is the gold standard rst line treatment for insomnia disorder, pharma­cotherapy plays a role in several clinical situations. Medications are often used for short-term insomnia, for individuals who cannot or choose not to undergo CBT-I, for individuals who did not respond fully to CBT-I treatment, and for individuals who require intermittent medication in addition to CBT-I. A limited number of medications are FDA approved for treatment of insomnia (Table13.2), although many other prescription medications, dietary supplements, and over-the-counter medications with sedating properties are used off-label in clinical practice. Importantly, off-label use of medications to treat insomnia but that are not FDA approved is also not recommended for use in clinical practice guidelines, generally due to the fact that the potential side effects from these medications outweigh the potential benets for treating insomnia disorder [86, 87].
Table 13.2 FDA medications approved for treatment of insomnia disorder in adults
Prescription medications Over-the-counter agents
Ambien (zolpidem) Belsomra (suvorexant) Butisol (butabarbital) Doral (quazepam) Edluar (zolpidem) Estazolam Flurazepam Halcion (triazolam) Hetlioz (tasimelteon) Intermezzo (zolpidem) Lunesta (eszopiclone) Restoril (temazepam) Rozerem (ramelteon) Seconal (secobarbital) Silenor (doxepin) Sonata (zaleplon) Zolpimist (zolpidem)
Source: US Food and Drug Administration [104]
a
Note: agents also in many cold and headache combination products
Benadryl (diphenhydramine) Unisom (doxylamine)
a
a