From the Guidelines
Cognitive behavioral therapy for insomnia (CBT-I) should be considered the first-line treatment for adults with chronic insomnia disorder, as it has the most evidence available in the literature and is the only approach to receive a Strong recommendation. This is based on a systematic review of the clinical trial literature that included meta-analyses of extracted data when possible, as stated in the American Academy of Sleep Medicine clinical practice guideline 1.
Key Considerations for CBT-I
- CBT-I is a multicomponent intervention that typically includes sleep restriction therapy, stimulus control, and some form of cognitive therapy.
- The exact treatment components may vary across studies, but in-person one-on-one delivery of CBT-I by a trained CBT-I provider is the most widely evaluated delivery method and is generally considered the best available treatment.
- Clinicians should discuss different CBT-I delivery modalities with their patients, including in-person individual treatment, group treatment, and internet-based programs, and align the delivery modality based on availability, affordability, treatment format, duration, and the patient’s preferences and values.
Alternative Treatments
- Other potentially useful interventions with minimal undesirable effects include behavioral therapy, sleep restriction therapy, stimulus control, and relaxation therapy, which all received Conditional recommendations 1.
- Sleep hygiene is not recommended as a single-component therapy due to the lack of evidence for its efficacy, but certain common-sense principles of sleep hygiene may be helpful in a comprehensive treatment approach.
Medication Options
- While CBT-I is the preferred treatment, medication options may be considered for short-term use, including over-the-counter choices like melatonin or diphenhydramine, or prescription medications like non-benzodiazepines, benzodiazepines, or sedating antidepressants 1.
- However, medications should generally be used for short periods (2-4 weeks) to prevent dependence, and clinicians should use a shared decision-making approach to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom CBT-I alone was unsuccessful.
From the FDA Drug Label
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV) Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Treatment for insomnia includes:
- Zolpidem: indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, and has been shown to decrease sleep latency for up to 35 days in controlled clinical studies 2 2.
- Ramelteon: indicated for the treatment of insomnia characterized by difficulty with sleep onset, with clinical trials performed in support of efficacy for up to six months in duration 3.
From the Research
Non-Pharmacologic Treatment Approaches
- Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective treatment approach, as evidenced by studies 4, 5, 6, 7.
- CBT-I encompasses various techniques, including sleep hygiene, stimulus control, sleep restriction, cognitive therapy, and relaxation training 6.
- Exercise and relaxation techniques are also recommended as part of a non-pharmacologic approach to treating insomnia 4.
- Complementary and alternative approaches, such as light therapy, aromatherapy, music therapy, and herbal medicine, may also be considered 4, 5.
Pharmacologic Treatment Considerations
- Pharmacologic options should be used with caution, especially in older adults, due to potential adverse effects and altered pharmacokinetics 8.
- Benzodiazepines are generally discouraged in the geriatric population, while non-benzodiazepine receptor agonists (non-BzRAs) have improved safety profiles but may still cause side effects such as dementia, serious injury, and fractures 8.
- Ramelteon and suvorexant may be considered as alternative pharmacologic options, with minimal adverse effect profiles and effectiveness in improving sleep-onset latency and sleep maintenance 8.
Treatment Recommendations
- Cognitive behavioral therapy should be considered the first-line treatment for insomnia, with non-pharmacologic interventions and treatment of comorbid conditions being the primary focus 4, 5, 6, 7, 8.
- Pharmacologic options should be reserved for cases where non-pharmacologic approaches are ineffective or insufficient, and should be used with caution and careful consideration of potential side effects 8.