OTC Insomnia Supplements: The Latest Evidence

Darren J. Hein, PharmD

Disclosures

March 15, 2019

Other Supplements

The safety and efficacy of other supplements for insomnia are described in the Table. Patients who choose to use any of these supplements should be informed of the limited or mixed study data and any potential harms.

Table. Summary of Safety and Efficacy of Other Supplement Sleep Aids

Supplement Clinical Efficacy Safety Concerns
Cannabidiol (CBD) Mixed results:
  • Taking 160 mg of CBD before bedtime significantly improved total sleep time over placebo in patients with insomnia in one study from the 1980s. Sleep duration was not improved with 40-mg and 80-mg doses.[15]

  • Taking 300 mg of CBD 30 minutes before a sleep study did not improve total sleep time, sleep latency, or sleep quality over placebo in healthy patients.[16]

CBD is generally well tolerated. Some bench research suggests that CBD can inhibit the metabolism of CYP 1A1, 1A2, 1B1, 2A6, 2B6, 2C19, 2C9, 2D6, and 3A4 substrates, potentially interacting with a number of drugs.[10]
Chamomile Limited research:
  • Taking 270 mg of German chamomile twice daily for 28 days did not improve total sleep time, sleep latency, or sleep quality over placebo in patients with chronic insomnia.[17]

German chamomile is generally well tolerated. Some cases of allergic reaction have been reported.[10]
Kava Mixed results:
  • Taking 70 mg of kavalactones each evening for 4 weeks significantly improved sleep quality over placebo in patients with sleep problems related to anxiety.[18]

  • Taking 100 mg of kavalactones three times daily for 4 weeks did not improve insomnia symptoms in patients with symptoms of anxiety and insomnia.[14]

Short-term use of kava is generally safe and well tolerated. However, reports of hepatotoxicity have been linked to kava.[10]
Lavender Mixed results:
  • Aromatherapy with lavender has improved measures of sleep quality in some studies, but other research has found no significant improvement in sleep parameters over placebo.[10]

No major safety concerns.[10]

CBD-Based Supplements

The use of CBD for a variety of ailments, including insomnia, is becoming much more popular as CBD-based supplements are readily available online and on the shelves of some convenience stores, natural health markets, and specialty retail shops. According to the US Food and Drug Administration (FDA), however, CBD is not considered a legal dietary supplement, even if it is derived from hemp. The US Food, Drug, and Cosmetics Act makes it illegal to introduce drug products into dietary supplements. Because CBD is now an ingredient in an FDA-approved prescription drug (Epidiolex), it is no longer considered a dietary supplement.[19,20] It is possible that this stance will change in the future, but until then, clinicians aiming to practice within the scope of the law should avoid making recommendations for non-FDA-approved CBD products.

Best Practices for a Good Night's Sleep

Best practices for managing insomnia start with good sleep hygiene, regular exercise, and treatment of any underlying conditions that may be causing sleep disturbances.

When pharmacotherapy is being considered, clinicians should recognize that not all patients will trust, be able to afford, or tolerate prescription drug products. Those who do wish to try supplement sleep aids should first be informed of any risks associated with their use. If the risks are minimal or manageable, clinicians should steer patients in the direction of supplements with evidence of efficacy. In many cases, the best option will be melatonin. Some patients may prefer other supplement sleep aids, even if the evidence regarding their use for insomnia is limited or conflicting; in these situations, clinicians should support patient preference. The perceived benefit that some patients report from these supplements, even if no more than a placebo effect, may be what is needed to achieve a good night's sleep.

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