What is the best non-habit forming sleep aid for difficulty initiating sleep, also known as insomnia (initiation of sleep)?

From the Guidelines

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the most effective non-pharmacological treatment for difficulty initiating sleep, also known as insomnia (initiation of sleep), as it has been shown to improve sleep outcomes and reduce symptoms of insomnia in adults. According to the American College of Physicians (ACP) guideline 1, CBT-I is recommended as the initial treatment for chronic insomnia disorder, with a strong recommendation and moderate-quality evidence. This approach combines cognitive therapy, behavioral interventions, and educational interventions to help individuals manage their insomnia.

Some key components of CBT-I include:

• Sleep restriction: limiting the amount of time spent in bed to improve sleep efficiency
• Stimulus control: associating the bed with sleep and removing distractions
• Relaxation strategies: techniques such as deep breathing, progressive muscle relaxation, and mindfulness to reduce stress and anxiety
• Sleep hygiene: practices such as maintaining a consistent sleep schedule, avoiding screens before bed, and creating a sleep-conducive environment

While pharmacological treatments, such as melatonin, may be effective for some individuals, the ACP guideline recommends a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom CBT-I alone was unsuccessful 1.

It's essential to note that the evidence for pharmacologic treatments, including melatonin, is insufficient or low strength, and the FDA has reported risks for cognitive and behavioral changes, including driving impairment, and other adverse effects 1. Therefore, CBT-I should be considered the first-line treatment for insomnia, with pharmacological treatments used only when necessary and under the guidance of a healthcare provider.

In terms of specific pharmacological treatments, the ACP guideline recommends that clinicians use a shared decision-making approach to decide whether to add pharmacological therapy, considering the benefits, harms, and costs of short-term use of medications 1. However, the guideline does not recommend a specific pharmacological treatment as the best non-habit forming sleep aid, and the evidence for most pharmacologic interventions is insufficient or low strength 1.

Overall, CBT-I is the most effective treatment for insomnia, and individuals should consult with a healthcare provider to determine the best course of treatment for their specific needs.

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 A human laboratory abuse potential study was performed in 14 subjects with a history of sedative/hypnotic or anxiolytic drug abuse.

The best non-habit forming sleep aid for difficulty initiating sleep is ramelteon 2.

• Ramelteon has been shown to reduce sleep latency in multiple studies.
• It is indicated for the treatment of insomnia characterized by difficulty with sleep onset 2.
• Melatonin is also a non-habit forming option, but the provided drug label does not contain sufficient information to support its effectiveness for sleep initiation 3. Note that while melatonin is described as "non-habit forming", the label for ramelteon does not explicitly state this, but it does discuss the results of a human laboratory abuse potential study, which suggests a lower potential for abuse compared to other sleep aids 2.

From the Research

Non-Habit Forming Sleep Aids for Insomnia

• Melatonin is a therapeutic treatment for insomnia, characterized by difficulty falling asleep or maintaining sleep, and has been shown to reduce sleep latency in most studies 4.
• The effective melatonin doses vary according to age group, ranging from 0.5 to 3 mg in children, 3 to 5 mg in adolescents, 1 to 5 mg in adults, and 1 to 6 mg in elderly people 4.
• Melatonin has been found to have mild side effects when taken in usual doses and does not demonstrate toxicity or severe side effects, nor dependence, even when administered at high doses 4.

Alternative Therapies

• Ramelteon, a melatonin receptor agonist, has been shown to be helpful for sleep initiation difficulties and is not classified as a controlled substance 5, 6.
• Ramelteon has been found to improve objectively assessed latency to persistent sleep and subjectively assessed sleep latency in patients with chronic insomnia 6.
• Suvorexant, an orexin receptor antagonist, has been used in combination with ramelteon to treat delayed sleep-wake phase disorder, with prompt improvement in difficulty with sleep initiation and waking up in the morning and daytime somnolence 7.

Pharmacological Options

• Nonbenzodiazepine hypnotic medications, such as zolpidem, zaleplon, and eszopiclone, have shorter durations of action than traditional benzodiazepines and may be associated with less risk of tolerance and abuse 8.
• Low-dose doxepin has been demonstrated to have efficacy for sleep maintenance insomnia, exhibiting robust effects in the latter third of the night 8.
• Other pharmacological options, such as serotonin antagonists and inverse agonists, have been investigated, but their efficacy and safety are still being studied 8.