What are the best treatments for insomnia (difficulty initiating or maintaining sleep)?

From the Guidelines

To combat insomnia effectively, cognitive behavioral therapy for insomnia (CBT-I) should be considered as the first-line treatment, as it has been shown to be highly effective in improving sleep outcomes and reducing symptoms of insomnia. According to the most recent and highest quality study 1, CBT-I is a multicomponent intervention that includes sleep restriction therapy, stimulus control, and cognitive therapy, and has been found to be effective in improving global outcomes, sleep onset latency, and sleep efficiency.

Some key components of CBT-I include:

• Establishing a consistent sleep schedule
• Creating a relaxing bedtime routine
• Making the bedroom conducive to sleep
• Limiting caffeine and alcohol close to bedtime
• Avoiding heavy meals at least 3 hours before sleep
• Regular exercise during the day, but avoiding vigorous activity within 3 hours of bedtime

For short-term insomnia, prescription medications such as eszopiclone (Lunesta, 1-3mg) or zolpidem (Ambien, 5-10mg) might be prescribed, as suggested by 1. However, these medications should be used with caution and only for a short period, as they can have adverse effects and may lead to dependence.

It's also important to note that sleep hygiene practices, such as avoiding excessive caffeine or alcohol, can be helpful in a comprehensive treatment approach, but should not be used as a single-component therapy, as the evidence for its efficacy is limited 1.

Overall, a combination of CBT-I and lifestyle changes can be an effective approach to managing insomnia, and CBT-I should be considered as the primary treatment option, with medication used as a secondary option for short-term use.

From the FDA Drug Label

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. Ramelteon reduced the average latency to persistent sleep at each of the time points when compared to placebo. Ramelteon reduced sleep latency at each time point when compared to placebo The best ways to combat insomnia include taking ramelteon or zolpidem as they have been shown to decrease sleep latency in controlled clinical studies 2, 2, 3.

• Ramelteon has been evaluated for up to six months in duration and has been shown to reduce sleep latency in adults and elderly patients.
• Zolpidem has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. Key points to consider when using these medications include:
• Dosage: Ramelteon 8 mg has been shown to be effective in reducing sleep latency, while the 16 mg dose conferred no additional benefit and was associated with higher incidences of fatigue, headache, and next-day somnolence.
• Duration of treatment: The clinical trials performed in support of efficacy were up to six months in duration for ramelteon and 4 to 5 weeks in duration for zolpidem.

From the Research

Treatment Options for Insomnia

The treatment of insomnia should involve a multi-disciplinary approach, focusing on implementing behavioral interventions, improving sleep hygiene, managing psychological stressors, hypnotic treatment, and pharmacological therapy 4.

• Cognitive behavioral therapy in conjunction with pharmacotherapy can minimize the needed dose and any resulting side effects 4.
• Non-benzodiazepine hypnotics such as zolpidem, eszopiclone, zaleplon are commonly used as adjunctive treatment 4, 5.
• Melatonin receptor agonist, ramelteon, is also used for the treatment of insomnia, particularly for sleep-onset difficulties 6, 7.

Pharmacological Treatment

Pharmacological treatment for insomnia includes:

• Zolpidem: effective for short-term treatment, but has a wide variety of adverse effects, including an increased risk of falls, hip fractures, and complex behaviors such as sleepwalking and hallucinations 4.
• Eszopiclone: appears to be an efficient drug with moderate effects on sleep onset and maintenance, with a lower risk of abuse and dependence compared to benzodiazepines 5, 8.
• Ramelteon: associated with reduced subjective sleep latency and improved sleep quality, but its clinical impact is small, and long-term trials are needed before solid conclusions can be established 6.

Safety Considerations

Safety considerations in the management of insomnia with hypnotics include:

• Next-day residual effects: non-benzodiazepines have a lower risk of residual effects compared to benzodiazepines 5, 7.
• Potential for abuse, tolerance, and dependence: non-benzodiazepines have a lower risk of abuse and dependence compared to benzodiazepines 5, 7.
• Adverse events: somnolence, dry mouth, and dizziness are common adverse events associated with hypnotics 8, 6.