What are the treatment options for persistent insomnia?

From the Guidelines

For persistent insomnia, I strongly recommend Cognitive Behavioral Therapy for Insomnia (CBT-I) as the first-line treatment, as it has been shown to be highly effective in improving sleep quality and reducing symptoms of insomnia, as supported by the most recent and highest quality study 1.

Key Components of CBT-I

• Sleep restriction therapy
• Stimulus control
• Cognitive therapy

Benefits of CBT-I

• Improved sleep quality
• Reduced sleep onset latency
• Increased remission rates
• Reduced wake after sleep onset
• Improved sleep efficiency

Additional Recommendations

• Maintain a consistent sleep schedule
• Create a dark and cool bedroom environment
• Avoid screens before bedtime
• Limit caffeine and alcohol
• Exercise regularly but not close to bedtime

Medication Options

• Non-benzodiazepine sleep aids like zolpidem (5-10mg), eszopiclone (1-3mg), or zaleplon (5-10mg) for short-term use (2-4 weeks maximum)
• Low-dose doxepin (3-6mg), trazodone (25-100mg), or melatonin (1-5mg) for longer-term management
• Over-the-counter options like diphenhydramine (25-50mg) should be used sparingly due to tolerance development, as noted in 1 and 1

Importance of Shared Decision-Making

• Clinicians should use a shared decision-making approach when considering pharmacological therapy, as recommended by 1 and 1
• Discuss benefits, harms, and costs of medication with patients

Underlying Conditions

• If insomnia persists, consult a healthcare provider to evaluate underlying conditions like sleep apnea, restless leg syndrome, or mood disorders that may be contributing factors, as suggested by 1 and 1

From the FDA Drug Label

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The treatment for persistent insomnia is ramelteon, as it has been shown to reduce sleep latency in clinical trials.

• The recommended dose is 8 mg, as the 16 mg dose conferred no additional benefit for sleep initiation and was associated with higher incidences of fatigue, headache, and next-day somnolence.
• Ramelteon has been evaluated for up to six months in duration, with the final formal assessments of sleep latency performed at the end of the six-month study. 2

From the Research

Treatment Options for Persistent Insomnia

• Cognitive Behavioral Therapy for Insomnia (CBT-I) is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep, delivered over six to eight sessions 3.
• CBT-I has been shown to be an effective treatment for adults with chronic insomnia, with clinically meaningful effect sizes, and no adverse outcomes reported 4.
• The primary goal of CBT-I is to address the perpetuating factors that contribute to the development of chronic insomnia, and it is now commonly recommended as first-line treatment for chronic insomnia 4.

Components of CBT-I

• Core components of CBT-I include:
  • Sleep Restriction Therapy
  • Stimulus Control Therapy
  • Sleep Hygiene
  • Cognitive Therapy
• These components are designed to help patients learn how to support and promote the body's natural sleep mechanism, leading to long-term improvements in sleep quality 5.

Effectiveness of CBT-I

• CBT-I has been shown to be effective in reducing insomnia severity and improving mental health in patients with comorbid mental disorders, including depression, post-traumatic stress disorder (PTSD), and alcohol dependency 6.
• The effect sizes for the reduction of insomnia severity post-treatment were moderate to large, and changes seemed to be sustained at later time points 4, 6.
• CBT-I is also an effective add-on treatment for improving mental health in patients with depression, PTSD, and symptom severity in outpatients with mixed diagnoses 6.

Availability and Utilization of CBT-I

• Despite its effectiveness, CBT-I is underutilized, primarily due to a shortage of trained practitioners and limited patient awareness of the treatment option 5, 7.
• Physicians and healthcare providers can play an important role in educating their patients about CBT-I and recommending it as a first-line treatment for chronic insomnia 5, 7.