What are the treatment options for severe insomnia?

From the Guidelines

Severe insomnia can be effectively treated with cognitive behavioral therapy for insomnia (CBT-I) as the first-line treatment, as recommended by the American Academy of Sleep Medicine 1.

Treatment Approach

The treatment approach for severe insomnia should prioritize CBT-I, which includes sleep restriction, stimulus control, and sleep hygiene practices. This approach has been shown to improve global outcomes, sleep outcomes, and quality of life in adults with chronic insomnia disorder 1.

• CBT-I is a multicomponent intervention that can be delivered in-person, individually or in groups, or through telephone- or Web-based modules.
• Sleep restriction, stimulus control, and sleep hygiene practices are essential components of CBT-I.
• CBT-I has been shown to be effective in improving sleep outcomes, including reduced sleep onset latency and wake after sleep onset, and improved sleep efficiency and sleep quality 1.

Medications and Supplements

While medications like zolpidem, eszopiclone, and temazepam can provide immediate relief, they should be used for a limited period, typically 2-4 weeks, and under the guidance of a healthcare professional 1.

• Melatonin supplements (1-3mg) taken 1-2 hours before bedtime can help regulate sleep-wake cycles.
• However, the use of medications and supplements should be carefully considered, and CBT-I should be the primary treatment approach.

Consultation and Further Evaluation

If insomnia persists beyond 4 weeks despite these interventions, consultation with a sleep specialist is recommended to rule out underlying conditions like sleep apnea, depression, or anxiety that require specific treatment 1.

• A sleep specialist can help identify underlying conditions and develop a personalized treatment plan.
• Further evaluation and treatment can help improve sleep outcomes and quality of life in adults with severe insomnia.

From the FDA Drug Label

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. Ramelteon reduced the average latency to persistent sleep at each of the time points when compared to placebo.

The treatment for severe insomnia is not directly addressed in the provided drug labels. However, ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset, and it has been shown to reduce sleep latency in clinical trials 2, 2.

• Ramelteon may be considered for the treatment of insomnia, but its effectiveness for severe insomnia is not explicitly stated.
• Zolpidem has also been evaluated for the treatment of chronic insomnia, and it has been shown to be superior to placebo on objective and subjective measures of sleep latency and sleep efficiency 3.
• However, the FDA drug label does not provide a direct answer to the question of severe insomnia treatment.

From the Research

Severe Insomnia Treatment Options

• 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 4.
• CBT-I has been shown to be an effective treatment for chronic insomnia, with clinically meaningful effect sizes, and is now commonly recommended as first-line treatment for chronic insomnia 5.
• The primary focus of CBT-I is to address the perpetuating factors that contribute to the development of chronic insomnia, and it has been found to produce results equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve long past the end of treatment 6.

Components of CBT-I

• Core components of CBT-I include:
  • Sleep Restriction Therapy
  • Stimulus Control Therapy
  • Sleep Hygiene
  • Cognitive Therapy
  • Relaxation techniques 4, 6
• These components work together to help patients learn how to support and promote the body's natural sleep mechanism.

Effectiveness of CBT-I

• CBT-I has been found to be effective in reducing insomnia severity, with moderate to large effect sizes, and in improving mental health in patients with comorbid mental disorders 7.
• The efficacy of CBT-I combined with eszopiclone has been found to be better than eszopiclone alone in the treatment of sleep disorders in ICU transferred out patients 8.
• 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 7.

Considerations for Treatment

• CBT-I is underutilized, primarily due to a shortage of trained practitioners and patients being more likely to learn about sleep medication as a treatment for their insomnia 6.
• 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 6.