What are the next steps for a patient with insomnia who has tried melatonin and has difficulty initiating sleep?

From the Guidelines

For insomnia with sleep initiation difficulties, I recommend starting with cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment, which includes sleep hygiene practices, stimulus control, and sleep restriction, as suggested by the American Academy of Sleep Medicine 1. This approach has been shown to be effective in addressing sleep initiation difficulties and improving overall sleep quality. If medication is needed, consider short-term use of a non-benzodiazepine sedative like eszopiclone (1-3mg) or zaleplon (5-10mg) taken 30 minutes before bedtime for 2-4 weeks, as recommended by the American Academy of Sleep Medicine 1. For a more natural approach, try timed-release melatonin (2-5mg) if regular melatonin was ineffective, or low-dose doxepin (3-6mg). Some key points to consider when implementing CBT-I include:

• Going to bed only when sleepy and maintaining a regular schedule
• Avoiding naps and using the bed only for sleep
• Leaving the bed after 20 minutes if unable to fall asleep and engaging in relaxing activities until drowsy
• Avoiding electronic devices 1-2 hours before bed, maintaining a consistent sleep schedule, keeping the bedroom dark and cool, and limiting caffeine after noon. These medications and therapies work by enhancing GABA activity in the brain or regulating sleep-wake cycles, helping to reduce the time it takes to fall asleep. If insomnia persists beyond 2-4 weeks of treatment, a sleep study may be warranted to rule out other sleep disorders like sleep apnea. It's also important to note that the choice of medication should be based on the patient's response to the first treatment, and factors such as treatment history, coexisting conditions, and specific side effect profiles should be taken into account when selecting a medication 1.

From the FDA Drug Label

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Zolpidem may be an option for your patient with insomnia who has trouble initiating sleep, as it has been shown to decrease sleep latency. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening 2.

From the Research

Treatment Options for Insomnia

• Cognitive Behavioral Therapy for Insomnia (CBT-i) is a recommended first-line treatment for chronic insomnia, as it produces sustained benefits without the risk of tolerance or adverse effects associated with pharmacologic approaches 3, 4.
• CBT-i has been shown to be effective in improving sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency in adults with chronic insomnia 3.
• The five key components of CBT-i are sleep consolidation, stimulus control, cognitive restructuring, sleep hygiene, and relaxation techniques 4.

Comparison of CBT-i and Pharmacological Treatment

• CBT-i is considered a safe and highly effective treatment for insomnia, with no side effects and fewer episodes of relapse compared to sleep medication 4.
• Pharmacological treatment, such as trazodone, may be effective in improving objective sleep duration and reducing hypothalamic-pituitary-adrenal axis activation in patients with insomnia and short sleep duration phenotype 5.
• However, the decision to treat chronic insomnia disorder with long-term hypnotics should be individualized and balance the potential risks of continuing hypnotic medication use with the risks of untreated persistent insomnia and associated functional limitations 6.

Special Considerations

• CBT-i has been shown to be effective in patients with mental disorders and comorbid insomnia, including depression, post-traumatic stress disorder, and alcohol dependency 7.
• CBT-i may be considered as a first-line treatment for patients with mental disorders and comorbid insomnia, given the many side effects of medication 7.
• The effectiveness of CBT-i in patients with insomnia and short sleep duration phenotype may be limited, and pharmacological treatment may be a viable alternative in these cases 5.