What is the most effective pharmacological treatment for insomnia?

From the Guidelines

The most effective treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I), which should be considered as the first-line treatment option due to its superior long-term outcomes and fewer adverse effects compared to pharmacotherapy. According to the 2020 clinical practice guidelines from the U.S. Department of Veterans Affairs and U.S. Department of Defense 1, CBT-I was found to be more effective than several pharmacotherapies, with equivalent short-term results but superior long-term outcomes.

Some key points to consider when treating insomnia include:

• Practicing good sleep hygiene, such as maintaining a regular sleep schedule, avoiding screens before bed, limiting caffeine and alcohol, and creating a comfortable sleep environment
• Considering melatonin (1-5mg taken 30-60 minutes before bedtime) as a first-line option for mild insomnia due to its safety profile and effectiveness
• Using prescription medications like zolpidem (Ambien, 5-10mg), eszopiclone (Lunesta, 1-3mg), or temazepam (Restoril, 15-30mg) only for short-term use (generally 2-4 weeks) and under medical supervision due to potential side effects and interactions with other medications
• Recognizing that nonpharmacologic behavioral interventions, such as CBT-I, are more effective than pharmacologic therapies for the treatment of chronic insomnia disorder, as stated in the 2019 clinical practice guidelines 1

It's essential to weigh the potential benefits and harms of each treatment option, considering the individual's specific needs and circumstances. As noted in the 2016 clinical practice guideline from the American College of Physicians 1, the goal of treatment for insomnia is to improve sleep and alleviate distress or dysfunction caused by the disorder. By prioritizing CBT-I and considering the individual's unique needs, healthcare providers can develop effective treatment plans that promote improved sleep quality and overall well-being.

From the FDA Drug Label

In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings The best medication for sleep between zolpidem and eszopiclone cannot be determined as the FDA drug labels for these medications do not directly compare the two.

• Zolpidem was shown to be effective in reducing sleep latency and improving sleep duration in clinical studies 2.
• Eszopiclone was also shown to be effective in decreasing sleep latency and improving sleep maintenance in clinical studies 3.

From the Research

Medications for Sleep

• The most effective therapies for insomnia utilize cognitive behavioral therapy in conjunction with pharmacotherapy to minimize the needed dose and any resulting side effects 4.
• Non-benzodiazepine hypnotics such as zolpidem, eszopiclone, zaleplon are the most used as adjunctive treatment for insomnia 4.
• Zolpidem is a helpful drug for the treatment of insomnia in conjunction with cognitive-behavioral therapy, but it has a wide variety of adverse effects, including an increased risk of falls, hip fractures, and complex behaviors such as sleepwalking and hallucinations 4.

Safety and Efficacy of Sleep Medicines

• Benzodiazepines are discouraged in the geriatric population, especially for long-term use, due to their adverse effects 5.
• Non-benzodiazepine receptor agonists (non-BzRAs) have improved safety profiles compared with benzodiazepines, but their side effects include dementia, serious injury, and fractures 5.
• Ramelteon has a minimal adverse effect profile and is effective for sleep-onset latency and increased total sleep time, making it a valuable first-line option 5.
• Suvorexant improves sleep maintenance and has mild adverse effects, including somnolence, but residual daytime sedation has been reported 5.

Pharmacological Interventions for Sleep

• There is insufficient evidence to suggest that pharmacotherapy improves the quality or quantity of sleep in hospitalized patients suffering from poor sleep 6.
• No drug class or specific drug was identified as superior even when compared to placebo or no treatment 6.
• Melatonin doses up to 10 mg may have little or no effect on any major sleep outcome over eight to 10 weeks in people with Alzheimer's disease and sleep disturbances 7.
• Trazodone 50 mg for two weeks may improve total nocturnal sleep time and sleep efficiency in people with moderate-to-severe Alzheimer's disease 7.
• Orexin antagonists may increase total nocturnal sleep time and decrease time awake after sleep onset, but have little or no effect on number of awakenings 7.