What is offered to somebody sleeping badly

"Sleeping badly" covers a lot. A bad week before a deadline. A baby. A partner who snores. A decade of lying awake at three in the morning.

This lesson is about one specific thing at the far end of that range: a diagnosable disorder called chronic insomnia disorder, and what three clinical guidelines say should be offered for it. It reports what they recommend, with the grade each attaches, and it stops there.

What the disorder is

The American College of Physicians published a guideline on it in 2016.¹ This course read both of its recommendations with their grades, its opening paragraph and one box of clinical considerations, not the reviews of trials behind it.

Its definition: "It is defined as dissatisfaction with sleep quantity or quality and is associated with difficulty initiating or maintaining sleep and early-morning waking with inability to return to sleep."

And how common it is: "Approximately 6% to 10% of adults have insomnia that meets diagnostic criteria."

Notice that the definition starts with dissatisfaction. After lesson 1 you'll see why that matters: the thing being diagnosed is partly a report, which on this course's reading makes the person describing it the first instrument. So a number from a device isn't what the definition turns on, and nothing in this lesson turns on one.

What a guideline grade is

Before the recommendations, the one idea that makes them readable.

A guideline grade usually has two parts, and they answer different questions. (This two-part summary is this course's, from what the three documents print.)⁴

• Strength of recommendation: how confident the panel is that following it is the right call for most patients. Strong, or something weaker, which two guidelines here call weak and the third calls conditional.
• Quality of evidence: how good the studies behind it are. High, moderate, low.

The ACP prints both on every recommendation. The two sleep academy guidelines print the strength beside each recommendation and discuss the quality of evidence in the text under it. Both use a system called GRADE, short for Grading of Recommendations Assessment, Development and Evaluation.

What the two strengths mean, in the 2021 guideline's words: "A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. A "conditional" recommendation is one that requires that the clinician use clinical knowledge and experience, and to strongly consider the patient's values and preferences to determine the best course of action."²

That one idea stops this lesson being read as "the pills don't work", which is not what any of the three documents says.

Three guidelines, one table

Here's what each recommends for chronic insomnia in adults, with its grade. The first two rows are the ACP's. The next six are the American Academy of Sleep Medicine's 2021 guideline on behavioural and psychological treatments.² The last is its 2017 guideline on drugs, which makes fourteen recommendations and gives every one of them the same grade.³

CBT-I is cognitive behavioural therapy for insomnia, and the section after next says what's in it. The evidence column for the 2021 guideline is its own summary of each recommendation. The 2017 guideline reviews the evidence for each drug in its full text, and this course didn't read those reviews, so it prints no quality for them.

One more thing before you read the table as a ranking. The drug guideline says what it's for: helping clinicians in "choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated".³ It doesn't rank drugs against therapy, and nor does this table.

Reading the column

Now read the strength column from top to bottom.

The talking therapy has a strong recommendation in both documents that grade it, on moderate-quality evidence. Every medication recommendation, fifteen lines if you count the ACP's one and the drug guideline's fourteen, is weak. Nothing about a drug is strong.

That's a fact about three documents. It's worth having because the ranking many people assume runs the other way round, pills as the real treatment and therapy as the soft option, which is this course's impression rather than anything it measured.⁴

What the pattern does support is narrower and still worth having. The one panel that graded both, the ACP's, was more confident about CBT-I first than about adding a drug, and says so in its first recommendation: "ACP recommends that all adult patients receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder. (Grade: strong recommendation, moderate-quality evidence)"¹

Its second recommendation is about what happens after that, and it is worth reading whole, because it is a description of a conversation and not a prescription: "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)"¹

Two more sentences from the same guideline belong beside that one. On how long: "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." And on what nobody knows: "Chronic insomnia disorder itself may have deleterious health effects. However, whether medications decrease the harmful health effects of sleep deprivation is unknown."¹

Those are a clinician's considerations, not a schedule for anybody reading this. The drug guideline ends its recommendations the same way: "The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources."³ This course read no evidence on the harms of any drug, and the ACP's second recommendation names "benefits, harms, and costs" as part of the conversation.

What CBT-I is

It isn't being told to relax. The ACP's description: "Cognitive behavioral therapy for insomnia consists of a combination of treatments that include cognitive therapy around sleep, behavioral interventions (such as sleep restriction and stimulus control), and education (such as sleep hygiene). It can be performed in primary care."¹

So it is a package, and the 2021 guideline graded some of its parts on their own as well: stimulus control, sleep restriction and relaxation, each with a conditional recommendation on a small body of low-quality evidence. This lesson names stimulus control without describing it. The strong recommendation is for the whole package, and the guideline adds a remark about who delivered it in the studies behind the grade: "This recommendation is based primarily on studies in which CBT-I was delivered by a trained professional to patients with and without comorbid conditions."² (Comorbid means other conditions alongside the insomnia.) It also found "insufficient evidence to make recommendations for specific delivery methods (eg, individual, group, internet, self-help, video)".²

The same guideline is plain about what CBT-I costs a patient: "In most cases, a noticeable improvement in insomnia symptoms is not immediate (as is the case with pharmacological interventions), and CBT-I treatment typically ranges from 4–8 visits, both of which may serve as barriers to treatment completion." And: "patients may face barriers to accessing CBT-I, including higher out-of-pocket costs as compared to medications, or locating a skilled provider in their geographic region."²

And what it offers in return, in the same summary: "Benefits of CBT-I include treatment gains that are potentially durable over the long term without the need for additional interventions." And: "CBT-I may reduce the need for pharmacologic therapy and thereby reduce patient risk of drug-related adverse events."²

Its harms, in the guideline's words: "The principal harms associated with CBT-I are symptoms of daytime fatigue and sleepiness, mood impairment (eg, irritability), and cognitive difficulties (eg, attention problems) during treatment; however, these undesirable effects are primarily restricted to the early stages of treatment, when behavioral therapies are introduced, and improve over time, typically resolving by the end of treatment."² The panel judged that "the benefits of CBT-I strongly outweighed the short-term undesirable effects".

Sleep restriction, described and not instructed

One component needs a paragraph to itself, because it's the one a reader could most easily mistake for a tip, and the one with the clearest cautions.

Sleep restriction therapy deliberately shortens the time a person spends in bed, to begin with. The guideline describes what that costs early on: "Potential harms may occur in the early phases of treatment such as increased daytime sleepiness and difficulties with concentration, but these effects typically dissipate as treatment progresses and time in bed is extended as sleep improves."²

And who it may not suit, in the guideline's words: "Clinicians should note that this treatment may be contraindicated in certain populations such as those working in high risk occupations (eg, heavy machinery operators or drivers) or those predisposed to mania/hypomania poorly controlled seizure disorders or excessive daytime sleepiness."² (The missing "or" is in the original.)

Put that beside lesson 2, where healthy adults held to fewer hours were largely unaware of their own decline. They weren't insomnia patients, so this is this course's reason for caution rather than a finding about this treatment. It's why this lesson says what sleep restriction is and gives no protocol for it.

Sleep hygiene, precisely

Sleep hygiene is what most articles about sleep consist of. The 2021 guideline defines it as "A set of general recommendations about lifestyle (eg, diet, exercise, substance use) and environmental factors (eg, light, noise, temperature) that may promote or interfere with sleep."²

And its sixth recommendation: "We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL)."²

This is the worked example, because it is easy to read that sentence as saying more than it does.

What it does say rests on two things, and the guideline names both. The evidence: "The TF made a conditional recommendation against use of sleep hygiene as a single-component therapy based on indirect evidence showing that sleep hygiene was less effective than other treatments when used alone." (TF is the guideline's task force.) And the cost of time: "allocation of resources for sleep hygiene alone may divert resources and delay the use of other single- or multicomponent behavioral interventions that are more effective."²

Notice that the second reason is about what a clinic's time is best spent on, and the guideline ties it to the first: it calls sleep hygiene on its own a "minimally effective treatment". The same guideline, while saying it shouldn't be used by itself "due to the lack of evidence for its efficacy", adds that "certain common-sense principles of sleep hygiene (eg, avoiding excessive caffeine or alcohol) may nevertheless be helpful in a comprehensive treatment approach".²

So the guideline's position, fairly put, is that for somebody with diagnosed chronic insomnia, a leaflet of sleep tips shouldn't be the whole of what they're offered. That is much narrower than "sleep hygiene does not work", and further still from "don't bother".

Melatonin, and the over-the-counter shelf

Six of the drug guideline's fourteen recommendations are against something: diphenhydramine, melatonin, tryptophan, valerian, trazodone and tiagabine.³ The first four are sold without a prescription in some countries, though not everywhere, which is general background and not from these guidelines.⁴

Take melatonin, since it's the one readers are likeliest to have met. The recommendation, verbatim: "We suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK)."³

Read the parts of that sentence. Weak, so it is the panel's lower-certainty judgement and, on the guideline's own terms, not a finding that it does nothing. For insomnia, meaning chronic insomnia in adults, so it says nothing either way about jet lag or shift work, which the guideline is not about. Versus no treatment, which is the comparison each of the fourteen was made against. And it is from 2017, so medicines approved since then are not in it.

The eight drugs it suggests clinicians may use each come with a named type of insomnia: for example "suvorexant as a treatment for sleep maintenance insomnia" and "zaleplon as a treatment for sleep onset insomnia".³ This lesson names them because the guideline does. It does not describe any of them further, because deciding between them is a clinician's job with a patient in front of them.

Five things people get wrong

"Sleeping pills are the real treatment." None of the three guidelines gives any drug a strong recommendation, and the ACP names CBT-I as the initial treatment for all adult patients, strongly. The drug guideline's weak grades are partly a product of how drug trials are graded, which it says itself, so this is not "pills don't work" either.

"Melatonin is the safe natural option." For chronic insomnia in adults, the 2017 guideline suggests clinicians not use it, weakly. That's a statement about one use, not about the molecule. Whether it's safe is a question neither the guideline nor this course answers; what the guideline says is that, for this use, clinicians shouldn't reach for it.

"Good sleep hygiene is the treatment." For the disorder, the 2021 guideline suggests it not be used on its own, while saying it can be part of a package and that some of it may help.

"CBT-I is just being told to relax." Relaxation is one component among several, graded separately. The package is cognitive therapy, behavioural methods including sleep restriction and stimulus control, and education, and its strong grade rests mostly on studies in which a trained professional delivered it.

"CBT-I is quick and easy to get." The guideline that grades it strongly says improvement usually isn't immediate, treatment typically runs to four to eight visits, and cost and finding a trained provider can stand in the way.

Practice

Connections

Back. Lesson 1 said every sleep number carries the limits of its instrument; the diagnosis here starts with a person's own report. Lesson 2's participants were largely unaware of their own decline, which is one reason this course treats sleep restriction as a clinician's procedure. Lesson 3's line between evidence and recommendation is what a guideline grade makes explicit, in print, on every line.

Forward. Lesson 8 asks you to decide what, if anything, to change about your own sleep. This lesson is where that decision would stop being yours alone, and it is meant to leave you knowing when.

Go deeper

• The ACP guideline, Qaseem and colleagues, 2016. Its recommendations box is the most useful single page in this course for somebody who's actually sleeping badly. This course read the recommendations, the opening paragraph and the clinical considerations box.
• The AASM behavioural guideline, Edinger and colleagues, 2021, free at PubMed Central. Read in part: the abstract, the recommendations with their remarks, the evidence summaries on CBT-I and sleep hygiene, and the cautions on sleep restriction. The remarks under each recommendation are where the reasons live.
• The AASM drug guideline, Sateia and colleagues, 2017, free at PubMed Central. Read in part: the abstract, which lists all fourteen recommendations, and the definition of a weak recommendation. The evidence summaries for each drug weren't read.

Sources

1. Amir Qaseem and colleagues, for the Clinical Guidelines Committee of the American College of Physicians, "Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians", Annals of Internal Medicine 165, 2016, pp. 125 to 133, doi 10.7326/M15-2175. Read in part: both recommendations with their grades, the opening paragraph and the Clinical Considerations box. Supports: the definition, the prevalence, both recommendations, the description of CBT-I, the four-to-five-week horizon and the sentence on what is unknown.
2. J. D. Edinger and colleagues, "Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline", Journal of Clinical Sleep Medicine 17(2), 2021, pp. 255 to 262, doi 10.5664/jcsm.8986. Read in part: the abstract in full, and from the full text the recommendations with their remarks, the evidence summaries for CBT-I and sleep hygiene, the definition of sleep hygiene and the cautions on sleep restriction. Supports: the definitions of strong and conditional, the six recommendations, the study counts and evidence quality in the table, and every quotation about CBT-I, sleep hygiene and sleep restriction. The systematic review behind it was not read.
3. Michael J. Sateia and colleagues, "Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline", Journal of Clinical Sleep Medicine 13(2), 2017, pp. 307 to 349, doi 10.5664/jcsm.6470. Read in part: the abstract in full, including all fourteen recommendations, and the definition of a weak recommendation. Supports: the fourteen weak grades, the eight for and six against, the melatonin, suvorexant and zaleplon recommendations, and the sentences on what a weak grade does not mean and why drug evidence is predictably downgraded. The evidence summaries for individual drugs were not read, so no evidence quality is printed for them.
4. The course's own constructions, labelled where they appear. The two-part explanation of a grade is this course's plain-language summary of what the three documents print. The count of medication lines in "Reading the column" is this course's count from the table. The breathing and stretching guideline in quiz item 2 is invented. Over-the-counter sale "in some countries" is general background, not from these sources. The impression that many people rank pills above therapy is this course's, not a measurement. The reading of lesson 2's finding as a reason for caution about sleep restriction is this course's.