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Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.

Abstract

OBJECTIVE

To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia.

DATA SOURCES

A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials.

STUDY SELECTION

Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia.

RESULTS

Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects.

CONCLUSIONS

A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety.

Authors+Show Affiliations

Department of Family Medicine, Boston University, Boston, Massachusetts.Pfizer Consumer Healthcare, Pfizer Inc, Madison, New Jersey.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27057416

Citation

Culpepper, Larry, and Mark A. Wingertzahn. "Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: a Systematic Review of Efficacy and Safety." The Primary Care Companion for CNS Disorders, vol. 17, no. 6, 2015.
Culpepper L, Wingertzahn MA. Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety. Prim Care Companion CNS Disord. 2015;17(6).
Culpepper, L., & Wingertzahn, M. A. (2015). Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety. The Primary Care Companion for CNS Disorders, 17(6). https://doi.org/10.4088/PCC.15r01798
Culpepper L, Wingertzahn MA. Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: a Systematic Review of Efficacy and Safety. Prim Care Companion CNS Disord. 2015;17(6) PubMed PMID: 27057416.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety. AU - Culpepper,Larry, AU - Wingertzahn,Mark A, Y1 - 2015/12/31/ PY - 2015/02/05/received PY - 2015/06/23/accepted PY - 2016/4/9/entrez PY - 2015/1/1/pubmed PY - 2015/1/1/medline JF - The primary care companion for CNS disorders JO - Prim Care Companion CNS Disord VL - 17 IS - 6 N2 - OBJECTIVE: To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia. DATA SOURCES: A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials. STUDY SELECTION: Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia. RESULTS: Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects. CONCLUSIONS: A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety. SN - 2155-7772 UR - https://www.unboundmedicine.com/medline/citation/27057416/full_citation L2 - http://www.psychiatrist.com/PCC/article/Pages/2015/v17n06/15r01798.aspx DB - PRIME DP - Unbound Medicine ER -
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