What is the first line sleep aid?

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From the Guidelines

Cognitive behavioral therapy for insomnia (CBT-I) should be considered the first-line treatment for adults with chronic insomnia disorder. This recommendation is based on moderate-quality evidence that shows CBT-I improves global outcomes, including increased remission and treatment response, and reduced insomnia severity index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores compared with controls 1.

Some key points to consider when implementing CBT-I include:

  • It can be performed in primary care and has various delivery methods, such as individual or group therapy, telephone- or Web-based modules, or self-help books.
  • CBT-I is a multicomponent intervention that typically includes sleep restriction therapy, stimulus control, and some form of cognitive therapy.
  • While in-person one-on-one delivery of CBT-I by a trained provider is the most widely evaluated method, other delivery modalities, such as internet-based programs, can also be effective and may be more accessible for some patients 1.

In terms of pharmacological treatment, a shared decision-making approach should be used to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom CBT-I alone was unsuccessful. This approach should include a discussion of the benefits, harms, and costs of short-term use of medications 1.

Some key points to consider when using pharmacological treatment include:

  • Benefits of pharmacologic treatment include improved sleep outcomes, such as sleep onset latency and total sleep time.
  • Low-quality evidence shows that eszopiclone, zolpidem, and doxepin can improve sleep outcomes, but the evidence is limited, and the potential harms and costs of these medications should be carefully considered 1.
  • Other medications, such as sedating antidepressants and anticonvulsant medications, may be recommended as second- or third-line agents, particularly when comorbidities are present 1.

Overall, CBT-I should be the first-line treatment for chronic insomnia disorder, and pharmacological treatment should be considered only after CBT-I has been tried and found to be ineffective. By prioritizing CBT-I and using a shared decision-making approach to pharmacological treatment, clinicians can provide effective and safe treatment for adults with chronic insomnia disorder.

From the FDA Drug Label

Helps establish normal sleep patterns nighttime sleep aid for occassional sleeplessness The melatonin 3mg tablets can be used as a first line sleep aide for occasional sleeplessness.

  • Key benefits: 100% drug-free and non-habit forming
  • Usage: nighttime sleep aid 2

From the Research

First Line Sleep Aide

  • Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as the first line intervention for insomnia 3, 4, 5.
  • CBT-I is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep, and is delivered over the course of six to eight sessions 3.
  • The primary focus of CBT-I is to address the perpetuating factors that contribute to the development of chronic insomnia, which is a risk factor for multiple medical and psychiatric disorders 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 five key components of CBT-I are sleep consolidation, stimulus control, cognitive restructuring, sleep hygiene, and relaxation techniques 5.
  • CBT-I is underutilized, primarily due to a shortage of trained practitioners and lack of patient awareness, highlighting the need for physicians and healthcare providers to educate patients about CBT-I as a first-line treatment for chronic insomnia 5.

Non-Pharmacologic Interventions

  • Behavioral interventions, such as CBT-I, are recommended as first-line therapy prior to using pharmacologic therapy due to the side effects of sedative hypnotics 6.
  • Non-pharmacologic interventions, such as relaxation techniques, sleep hygiene, and bright light exposure, have been used to improve sleep quality and quantity in hospitalized patients, but the evidence is insufficient to draw conclusions 6.
  • CBT-I has been found to be an effective alternative to pharmacotherapy in individuals with insomnia, with benefits including remission, improved sleep onset latency, wakefulness after sleep, sleep efficiency, and sleep quality 7.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer.

Klinicheskaia i spetsial'naia psikhologiia = Clinical psychology and special education, 2022

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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