From the Guidelines
For refractory insomnia, a combination of cognitive behavioral therapy for insomnia (CBT-I) and medication is often recommended, with CBT-I being the first-line treatment, as supported by the American Academy of Sleep Medicine systematic review and meta-analysis 1.
Treatment Approach
Start with CBT-I, which includes sleep restriction, stimulus control, and relaxation techniques. This should be done with a trained therapist for 6-8 weekly sessions. If CBT-I alone is insufficient, add medication:
- First-line: Nonbenzodiazepine hypnotics like zolpidem (5-10mg) or eszopiclone (1-3mg) at bedtime for 2-4 weeks.
- Second-line: Low-dose doxepin (3-6mg) or ramelteon (8mg) at bedtime.
- For comorbid depression/anxiety: Consider mirtazapine (7.5-15mg) or trazodone (25-100mg) at bedtime. Avoid long-term use of benzodiazepines due to dependency risks. Implement strict sleep hygiene: consistent sleep schedule, no screens before bed, cool dark room, avoid caffeine/alcohol near bedtime. This approach combines addressing underlying thought patterns and behaviors with short-term pharmacological support. CBT-I provides long-term benefits by retraining sleep habits, while medications offer immediate relief. The goal is to gradually taper medication use as sleep patterns improve with CBT-I, as recommended by the American College of Physicians 1 and the U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines 1.
Key Considerations
- CBT-I is a multicomponent intervention that has been shown to be effective in treating chronic insomnia disorder, with a strong recommendation from the American Academy of Sleep Medicine 1.
- The choice of medication should be based on the patient's response to the first-line treatment, with consideration of factors such as comorbidities, past treatment history, and potential side effects, as discussed in the clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults 1.
- Sleep hygiene education and pharmacotherapy are commonly offered treatments for chronic insomnia disorder, but should not be considered first-line therapies, as concluded by the U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines 1.
From the FDA Drug Label
The provided drug labels do not directly address the treatment options for refractory insomnia.
The FDA drug label does not answer the question.
From the Research
Treatment Options for Refractory Insomnia
The treatment options for refractory insomnia include:
- Non-pharmacologic approaches, such as cognitive-behavioral therapy for insomnia (CBT-I), exercise, and relaxation techniques 2
- Complementary and alternative approaches, including light therapy, aromatherapy, music therapy, and herbal medicine 2
- Pharmacologic approaches, such as hypnotic agents, including older medications and newer hypnotics with a better safety profile and longer-term efficacy 3
- Alternative treatments, including acupuncture, exogenous melatonin, mind-body interventions, and repetitive transcranial magnetic stimulation (rTMS) 4
Non-Pharmacologic Treatments
Non-pharmacologic treatments are generally considered first-line treatment for insomnia, and include:
- Cognitive-behavioral therapy for insomnia (CBT-I) 2, 4, 5
- Exercise and relaxation techniques 2
- Lifestyle changes, such as establishing a consistent sleep schedule and creating a sleep-conducive environment 6
Pharmacologic Treatments
Pharmacologic treatments for insomnia include:
- Hypnotic agents, such as benzodiazepines and non-benzodiazepine hypnotics 3, 5, 6
- Melatonin receptor agonists 5
- Histamine receptor agonists 5
Alternative Treatments
Alternative treatments for insomnia include: