From the Guidelines
Insomnia management should follow a stepwise approach, beginning with cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment, as recommended by the American College of Physicians 1.
First-Line Treatment
- CBT-I includes sleep hygiene education, stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring, typically delivered over 6-8 sessions.
- CBT-I can be performed in primary care and has various delivery methods, including individual or group therapy, telephone- or Web-based modules, or self-help books.
- The evidence suggests that CBT-I is effective in improving global outcomes, sleep outcomes, and quality of life in adults with chronic insomnia disorder, with moderate-quality evidence showing improved sleep efficiency, reduced sleep onset latency, and wake after sleep onset 1.
Second-Line Treatment
- If CBT-I is insufficient, second-line treatment involves short-term use of medications such as low-dose doxepin (3-6mg), ramelteon (8mg), or over-the-counter melatonin (0.5-5mg) 1.
- These medications should be used at the lowest effective dose for the shortest duration possible due to risks of tolerance, dependence, and side effects.
Third-Line Treatment
- For third-line treatment, consider short-term use of non-benzodiazepine hypnotics like zolpidem (5-10mg), eszopiclone (1-3mg), or zaleplon (5-10mg) for 2-4 weeks 1.
- Non-benzodiazepine hypnotics have been shown to improve sleep outcomes, including reduced sleep onset latency and wake after sleep onset, with low- to moderate-quality evidence 1.
Fourth-Line Treatment
- Fourth-line options include benzodiazepines such as temazepam (15-30mg) or lorazepam (0.5-2mg), or sedating antidepressants like trazodone (25-100mg) or mirtazapine (7.5-15mg) 1.
- Benzodiazepines and sedating antidepressants should be used with caution due to risks of tolerance, dependence, and side effects, and only when other treatment options have been exhausted.
Throughout all treatment lines, continue reinforcing sleep hygiene practices, addressing underlying conditions like depression or anxiety, and monitoring for medication effectiveness and adverse effects. The goal is to restore normal sleep patterns while minimizing medication use, as the brain's natural sleep mechanisms are most effective for restorative sleep.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Insomnia Management
Insomnia management involves a stepped approach with different lines of treatment. The following are the recommended lines of treatment for insomnia:
- First-line treatment: Cognitive-behavioral therapy for insomnia (CBT-I) is considered the first-line treatment for chronic insomnia 2, 3, 4, 5. CBT-I is a multimodal intervention that targets the perpetuating factors of insomnia, including sleep restriction, stimulus control, and cognitive therapy.
- Second-line treatment: If CBT-I is not available or effective, pharmacotherapy can be considered as a second-line treatment 6. This may include benzodiazepines, hypnotic benzodiazepine receptor agonists, melatonin, and sedating antidepressants.
- Third-line treatment: For patients who do not respond to CBT-I or pharmacotherapy, other treatments such as sleep hygiene education, relaxation training, and stimulus control therapy may be considered 2.
- Fourth-line treatment: In some cases, alternative therapies such as mindfulness-based stress reduction, yoga, or acupuncture may be considered as a fourth-line treatment, although the evidence for these therapies is limited 2.
Key Components of CBT-I
The key components of CBT-I include:
- Sleep restriction therapy
- Stimulus control therapy
- Sleep hygiene education
- Cognitive therapy
- Relaxation training
These components are designed to address the perpetuating factors of insomnia and help patients develop healthy sleep habits. CBT-I is typically delivered over 6-8 sessions and has been shown to be effective in improving sleep outcomes in adults with chronic insomnia 3, 4.