Treatment of Insomnia

First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)

All patients with chronic insomnia must receive CBT-I as the initial treatment before any pharmacological intervention. 1, 2, 3

Why CBT-I First

CBT-I produces superior long-term outcomes compared to medications, with clinically meaningful improvements sustained for up to 2 years after treatment ends, while pharmacotherapy shows degradation of benefit after discontinuation. 1, 3, 4
The American College of Physicians provides a strong recommendation (moderate-quality evidence) that CBT-I be the initial treatment for all adults with chronic insomnia. 3
CBT-I is effective in 70-80% of patients, significantly reducing sleep-onset latency by approximately 19 minutes, wake after sleep onset by 26 minutes, and improving sleep efficiency by nearly 10%. 4, 5

Core Components of CBT-I

CBT-I must include at least 3 of the following evidence-based components: 1, 2, 4

Stimulus control therapy: Reassociate the bed with sleep by going to bed only when sleepy, getting out of bed if unable to sleep within 15-20 minutes, and using the bed only for sleep and sex. 1
Sleep restriction therapy: Limit time in bed to match actual sleep time, then gradually increase as sleep efficiency improves (typically starting when sleep efficiency reaches 85-90%). 1, 2
Cognitive restructuring: Address maladaptive thoughts and anxiety about sleep through structured cognitive therapy. 2, 3
Relaxation techniques: Progressive muscle relaxation, deep breathing, or guided imagery. 1
Sleep hygiene education: Avoid excessive caffeine, evening alcohol, late exercise, frequent daytime napping, and optimize sleep environment—though this alone is insufficient as monotherapy. 6, 2

Delivery Formats

In-person, therapist-led programs are most beneficial, typically requiring 4-8 sessions over 6 weeks. 3
Digital CBT-I is an effective and scalable alternative when in-person therapy is unavailable, with internet-based programs showing clinically significant improvements. 1, 3
Other effective formats include group sessions, telephone-based programs, and self-help books. 1, 6

Critical Cautions with CBT-I

Sleep restriction should be used cautiously in patients with seizure disorder or bipolar disorder due to potential sleep deprivation effects. 6
Improvements are gradual—patients need counseling that benefits develop over weeks but are sustained long-term, unlike the immediate effects of medications. 6, 3

Pharmacological Treatment: When and What to Prescribe

When to Consider Medications

Pharmacotherapy should only be considered when: 1, 2

Patients are unable to participate in CBT-I (due to availability, cost, or unwillingness)
Symptoms persist despite adequate CBT-I trial
As a temporary adjunct to CBT-I in select cases

Medications should supplement, not replace, CBT-I—all patients receiving pharmacotherapy must continue behavioral interventions. 6, 2

First-Line Pharmacological Options

For Sleep Onset Insomnia

Short/intermediate-acting benzodiazepine receptor agonists (BzRAs) or ramelteon are first-line agents: 6

Zaleplon 10 mg (5 mg in elderly): Ultra-short-acting, can be taken mid-night if ≥4 hours remain before awakening. 6
Zolpidem 10 mg (5 mg in elderly, especially women): Effective for both onset and maintenance. 6, 7
Triazolam 0.25 mg: Effective but associated with rebound anxiety, not considered optimal first-line. 6
Ramelteon 8 mg: Melatonin receptor agonist with no abuse potential, safe for long-term use. 6, 8

For Sleep Maintenance Insomnia

Eszopiclone 2-3 mg: Addresses both sleep onset and maintenance, approved for long-term use. 6, 9
Zolpidem 10 mg (5 mg in elderly): Effective for maintenance as well as onset. 6, 7
Temazepam 15 mg: Intermediate-acting benzodiazepine for both onset and maintenance. 6
Doxepin 3-6 mg: Highly selective H1 antagonist, reduces wake after sleep onset by 22-23 minutes with strong evidence. 6
Suvorexant 10-20 mg: Orexin receptor antagonist, reduces wake after sleep onset by 16-28 minutes. 6

Second-Line and Alternative Options

When First-Line Agents Fail

If initial BzRAs or ramelteon are unsuccessful, try an alternative agent in the same class before moving to other options. 6

For patients with comorbid depression or anxiety, sedating antidepressants become appropriate: 6

Mirtazapine: Must be taken nightly on a scheduled basis (not PRN) due to 20-40 hour half-life; particularly appropriate with comorbid depression. 6
Low-dose doxepin 3-6 mg: Effective for sleep maintenance without the anticholinergic burden of higher doses. 6

Newer orexin antagonists (lemborexant, daridorexant): Similar efficacy to suvorexant with potentially improved pharmacokinetics and lower risk of cognitive/psychomotor effects compared to benzodiazepines. 6

Medications to AVOID

Explicitly Not Recommended

Trazodone: The American Academy of Sleep Medicine explicitly recommends against trazodone for insomnia—trials show modest improvements in sleep parameters but no improvement in subjective sleep quality, with harms outweighing benefits. 6
Over-the-counter antihistamines (diphenhydramine, doxylamine): Lack efficacy data, cause daytime sedation, anticholinergic effects, and delirium risk especially in elderly patients. 6, 2
Herbal supplements (valerian) and melatonin: Insufficient evidence of efficacy. 6
Older hypnotics (barbiturates, chloral hydrate): Not recommended due to safety concerns. 6
Tiagabine: Not recommended for sleep onset or maintenance insomnia. 6
Antipsychotics: Should not be used as first-line treatment due to problematic metabolic side effects. 6

Traditional Benzodiazepines (Lorazepam, Diazepam)

Traditional benzodiazepines like lorazepam and diazepam should NOT be used as first-line treatment for insomnia. 6

These are considered second or third-line options only after first-line BzRAs have failed. 6
They carry significantly higher risks including dependence, withdrawal reactions, cognitive impairment, falls, daytime sedation, and associations with dementia—particularly in older adults. 6
Long-acting benzodiazepines (diazepam) cause drug accumulation, prolonged daytime sedation, and increased fall risk. 6

Special Populations and Safety Considerations

Elderly Patients (Age 65+)

Older adults require lower doses and careful medication selection: 6

Zolpidem maximum 5 mg (not 10 mg) due to increased sensitivity and fall risk. 6
Ramelteon 8 mg or low-dose doxepin 3 mg are safest choices with minimal fall risk and cognitive impairment. 6
Elderly patients are at higher risk for complex sleep behaviors (sleep-driving, sleep-walking), falls, cognitive impairment, and fractures with all hypnotics. 6

Patients with Substance Abuse History

For patients with history of substance abuse, avoid benzodiazepines and consider: 6

Ramelteon: No abuse potential, safe for long-term use. 6, 8
Suvorexant or other orexin antagonists: Lower abuse potential than benzodiazepines. 6

Patients with Hepatic Impairment

Zaleplon dose should be reduced to 5 mg in patients with hepatic impairment, as clearance is reduced by 70% in compensated cirrhosis and 87% in decompensated cirrhosis. 6
Lemborexant and other orexin antagonists require dose adjustment but remain safer than benzodiazepines, which have significantly impaired clearance in liver disease. 6

Patients with Comorbid Medical Conditions

Assess for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders) if insomnia persists beyond 7-10 days of treatment. 6
For patients with cardiovascular disease: Sertraline has lower QTc prolongation risk than citalopram/escitalopram; mirtazapine is safe and aids sleep. 6

Critical Safety Warnings for All Hypnotics

Complex Sleep Behaviors

All BzRAs and Z-drugs may cause complex sleep behaviors including sleep-driving, sleep-walking, eating, talking, and having sex while not fully awake. 6, 9, 7

Patients must be warned about these risks before starting treatment. 6
Medication should be stopped immediately if patient discovers they performed activities while not fully awake. 6, 7
These behaviors are more common with higher doses and when combined with alcohol or other CNS depressants. 9, 7

Dosing and Administration Rules

Take medication only when able to stay in bed for a full 7-8 hours before needing to be active. 9, 7
Take right before getting into bed, not sooner. 9, 7
Do not take with or immediately after a meal—medications work faster on an empty stomach. 7
Never combine with alcohol or other sedatives unless specifically directed by physician. 9, 7

Morning-After Impairment

The morning after taking hypnotics, ability to drive safely and think clearly may be decreased. 9
This is particularly true for longer-acting agents and higher doses. 6
Women and elderly patients are at higher risk for morning impairment. 6

Drug Interactions

Combining multiple sedative medications significantly increases risks: 6

Increased fall risk, cognitive impairment, respiratory depression, and complex sleep behaviors. 6
Pregabalin (Lyrica) combined with orexin antagonists increases sedation risk as both are CNS depressants. 2

Treatment Duration and Monitoring

Short-Term Use Preferred

Use the lowest effective dose for the shortest duration possible, typically less than 4 weeks for acute insomnia. 6
Long-term use (beyond 4 weeks) requires periodic reassessment of continued need and effectiveness. 6, 2

Regular Monitoring Required

Reassess patients after 1-2 weeks to evaluate: 6

Efficacy on sleep latency, sleep maintenance, and daytime functioning
Adverse effects including morning sedation, cognitive impairment, and complex sleep behaviors
Continued need for medication versus optimization of CBT-I

Discontinuation Strategy

Medication should be tapered when conditions allow to prevent discontinuation symptoms and rebound insomnia. 6
CBT-I facilitates successful medication discontinuation by addressing underlying perpetuating factors. 6
Rapid discontinuation of benzodiazepines produces withdrawal symptoms including rebound insomnia, similar to barbiturates and alcohol. 6

Common Pitfalls to Avoid

Prescribing hypnotics as first-line treatment without attempting CBT-I—this violates guideline recommendations and deprives patients of more effective, durable therapy. 2, 3
Using traditional benzodiazepines (lorazepam, diazepam) as first-line agents instead of short/intermediate-acting BzRAs or ramelteon. 6
Failing to adjust doses in elderly patients—using adult doses (e.g., zolpidem 10 mg instead of 5 mg) significantly increases fall and cognitive impairment risk. 6
Continuing pharmacotherapy long-term without periodic reassessment and concurrent behavioral interventions. 6, 2
Combining multiple sedative medications without considering additive risks of falls, cognitive impairment, and respiratory depression. 6
Using over-the-counter antihistamines or herbal supplements with limited efficacy data and significant side effect profiles. 6, 2
Prescribing trazodone for insomnia despite explicit guideline recommendations against its use. 6
Failing to warn patients about complex sleep behaviors and the requirement to have 7-8 hours available for sleep. 9, 7
Not screening for underlying sleep disorders (sleep apnea, restless legs syndrome) when insomnia persists beyond 7-10 days. 6
Relying on sleep hygiene education alone without incorporating other CBT-I components—sleep hygiene is insufficient as monotherapy. 1, 2

What are the recommended treatment options for a patient with insomnia, considering their medical history and potential for substance abuse or dependence?

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