Non-pharmacological strategies include improving sleep hygiene and cognitive-behavioral therapy. Over-the-counter options include melatonin (1–5 mg 1–2 hours before bed), diphenhydramine (25–50 mg at bedtime), or valerian root (300–600 mg before bed), though benefits are modest and user preference varies. For persistent or severe cases, consider prescription medications like zolpidem, ramelteon, or suvorexant under a doctor’s guidance.
January 11, 2025

Insomnia: Know Your Options

Evidence-Based Over-the-Counter Guide

William Shen

William Shen

Co-founder & CPO

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Insomnia is difficulty falling or staying asleep and may be acute or chronic. The evidence supporting the benefits of pharmacotherapy for treating chronic insomnia is relatively weak overall, for both prescription and non-prescription medications. Hence there are no strong clinical recommendations for pharmacotherapy for chronic insomnia.

Non-phamacological recommendations:

  • Sleep hygiene: In the hour before bed, avoid alcohol, caffeine, nicotine, vigorous exercise, large meals, large fluid intake, bright lights, and electronic devices. Maintain a regular sleep/wake schedule. You can use the MDandMe journal to help you. If you are in bed and cannot sleep, leave the bedroom, write down all your thoughts, and return when tired.

  • Cognitive Behavioral Therapy for Insomnia (CBT-I): Effective with a clearly favorable benefit to risk ratio relative to medication; however many may not partake in treatment due to availability, cost restraints, willingness, etc.

Safe over-the-counter options. The American Academy of Sleep Medicine does not consider these agents to offer clinically significant improvement, but state the the “benefits approximately equal potential harms” and thus it is up to user preference:

  • Melatonin: Regulates sleep-wake cycles. Mean reduction in time to falling asleep by 9 minutes and small improvement in quality of sleep relative to placebo. Dose: 1-5 mg melatonin gummy taken 1-2 hours before bedtime. Don’t take more as overdosing can worsen insomnia.

  • Diphenhydramine: Sedating antihistamine for short-term use. Mean reduction in time to falling asleep by 8 minutes relative to placebo along with slight total sleep time improvement. Dose: 25-50 mg at bedtime as needed. This is the only generally FDA-approved nighttime sleep-aid drug product. ZzzQuil Nighttime Sleep Aid Liquid (FDA M010).

  • Valerian Root: Herbal supplement with sedative effects. Mean reduction in time to falling asleep by 9 minutes relative to placebo. Dose: 300-600 mg before bedtime. Valerian root herbal supplement (FDA GRAS). 

Prescription medications:

  • Zolpidem (Ambien): Non-benzodiazepine hypnotic for short-term use.

  • Suvorexant (Belsomra): An orexin receptor agonist.

  • Ramelteon (Rozerem): Melatonin agonist. 

  • Temaxepam (Restoril): Benzodiazepine sedative used to treat severe or debilitating insomnia in the short term

Citation:

Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017; 13(02): p.307-349. doi: 10.5664/jcsm.6470

What OTC evidence is reviewed?

  • For each condition, we performed a literature review to find a recent widely cited expert group guideline published in the leading specialty-specific peer-reviewed journal or top general medical journal.

  • Based on the recommendations in the publication, we identify recommended active ingredients and devices that are available over-the-counter per FDA regulations.

What evidence is prioritized?

Levels of evidence considered:

  • Tier 1 (Safe and Definitely Effective): Professional field consensus or multiple randomized controlled clinical trials showing the same conclusion. Wherever possible, we use Tier 1 evidence for "first-line" recommendations.

  • Tier 2 (Safe and Probably Effective): Individual clinical trials which may be discordant or large-scale observational experience. Tier 2 evidence may inform "first-line", "second-line", or "supplement" recommendations.

  • Tier 3 (Safe and Maybe Effective): Mechanistic plausibility without high-quality clinical evidence of efficacy but high-quality evidence of safety. Tier 3 evidence may inform "second-line" or "supplement" recommendations.

How does MDandMe select recommended products?

  • Based on the top clinical recommendation, we evaluate products containing the recommended active agent with FDA-approved dosage based on price, average customer reviews, how often it is purchased, and how quickly it will ship to home. 

  • We provide public documentation of the active ingredients in our recommendations, using all 32 FDA monographs, Prescription-to-Nonprescription (Rx-to-OTC) Switches, as well as New Drug Application (NDA) approvals.

How does MDandMe select recommended devices?

  • Based on the top clinical recommendation, we evaluate devices that are FDA-cleared or comply with other medical guidelines (if not a FDA-regulated category) by reputability, price, and average customer reviews.

  • We provide public documentation of supporting evidence for each device.  

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You can view all of our published OTC guides here.

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