From the Guidelines
Primary insomnia treatment should begin with cognitive behavioral therapy for insomnia (CBT-I), which is considered the first-line treatment. This approach includes sleep hygiene education, stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring, as recommended by the American Academy of Sleep Medicine 1. For sleep hygiene, patients should maintain consistent sleep-wake times, avoid caffeine and alcohol before bedtime, create a comfortable sleep environment, and limit screen time before bed. CBT-I has been shown to improve global outcomes, including increased remission and treatment response, and reduced insomnia severity index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores compared to controls 1.
Key Components of CBT-I
- Sleep restriction therapy
- Stimulus control
- Cognitive therapy
- Relaxation techniques
- Sleep hygiene education
If non-pharmacological approaches are insufficient, short-term medication may be considered, with a shared decision-making approach discussing the benefits, harms, and costs of pharmacological therapy 1. Options include non-benzodiazepine hypnotics, melatonin, or sedating antidepressants, which should be used cautiously due to potential side effects and dependence risk. Treatment should be individualized based on symptom pattern, comorbidities, and patient preferences, with regular reassessment to minimize medication use while maximizing sleep quality. The American College of Physicians recommends using a shared decision-making approach when considering pharmacological therapy 1, and the American Academy of Sleep Medicine suggests considering behavioral therapies, such as cognitive behavioral therapy for insomnia (CBT-I), as the primary treatment for chronic insomnia disorder 1.
From the FDA Drug Label
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) Adult outpatients with chronic insomnia (n=75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate and placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.
Primary insomnia treatment with zolpidem is supported by clinical studies, which showed that zolpidem 10 mg was superior to placebo on measures of sleep latency, total sleep time, number of awakenings, and sleep quality.
- Key findings include:
- Decreased sleep latency
- Improved sleep quality
- Increased total sleep time
- Reduced number of awakenings 2
From the Research
Primary Insomnia Treatment
- Cognitive Behavioral Therapy (CBT) is a viable intervention for primary sleep-maintenance insomnia, leading to clinically significant sleep improvements within 6 weeks and enduring through 6 months of follow-up 3.
- Non-pharmacological management of insomnia, including stimulus control, sleep restriction, sleep hygiene education, and cognitive therapy, is a feasible and effective alternative to pharmacological treatments 4.
- CBT for Insomnia (CBT-I) is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep, and is delivered over 6-8 sessions 5.
- Core components of CBT-I include Sleep Restriction Therapy, Stimulus Control Therapy, Sleep Hygiene, and Cognitive Therapy, which have been shown to improve sleep efficacy, sleep onset latency, and wake after sleep onset 5, 6.
- Systematic reviews and meta-analyses have demonstrated the efficacy of CBT-I in improving sleep outcomes, including sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency 6, 7.
- CBT-I has been recommended as a first-line treatment for chronic insomnia due to its sustained benefits and lack of risk for tolerance or adverse effects associated with pharmacologic approaches 7.