Are Safety Warnings for Commonly-Used Sleeping Pills Reaching Those who Need them Most?

A. S. Kesselheim , M. S. Sinha , P. Rausch et al., “Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey,” Journal of Law, Medicine & Ethics 47, no. 3 (2019): 430-441.

U. S. Food and Drug Administration, “Drug Safety Communication: FDA Approves New Label Changes and Dosing for Zolpidem Products and a Recommendation to Avoid Driving the Day after Using Ambien CR,” May 14, 2013, available at <http://www.fda.gov/Drugs/DrugSafety/ucm352085.htm> (last visited July 30, 2019); U.S. Food and Drug Administration, “Drug Safety Communication: Risk of Next Morning Impairment after Use of Insomnia Drugs; FDA Requires Lower Recommended Doses fo Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist),” January 10, 2013, available at <https://www.fda.gov/media/84992/download> (last visited July 30, 2019).

U. S. Food and Drug Administration, Drug Safety Communication: FDA Warns of Next-Day Impairment with Sleep Aid Lunesta (eszopiclone) and Lowers Recommended Dose,” May 15, 2014, available at <https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-next-day-impairment-sleep-aid-lunesta-eszopicloneand-lowers> (last visited July 30, 2019).

A. S. Kesselheim , S. A. McGraw , S. Z. Dejene , et al., “Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study,” Drug Safety 40, no. 6 (2017): 531-542.

See Kesselheim, et. al., supra note 1.

A. S. Kesselheim , E. G. Campbell , S. Schneeweiss , et al., “Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications,” Drug Safety 38, no. 6 (2015): 565-575.

A. S. Kesselheim , M. Donneyong , G. J. Dal Pan , et al., “Changes in Prescribing and Healthcare Resource Utilization after FDA Drug Safety Communications Involving Zolpidem-Containing Medications,” Pharmacoepidemiology & Drug Safety 26, no. 6 (2017): 712-721.

S. B. Dusetzina , A. S. Higashi , E. R. Dorsey , et al., “Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review,” Medical Care 50, no. 6 (2012): 466-478.

S. Piening , “Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands,” Clinical Pharmacology and Therapeutics 91, no. 5 (2012): 838-845.

B. Hugman and I. R. Edwards , “The Challenge of Effectively Communicating Pateint Safety Information,” Expert Opinion on Drug Safety 5, no. 4 (2006): 495-599.

See Kesselheim et al., supra note 1.

L. M. Schwartz and S. Woloshin , “Medical Marketing in the United States, 1997-2016,” JAMA 321, no. 1 (2019): 80-96.

Community Catalyst Blog, “Bitter Pill Award Winner Lunesta has Most Recalled Drug Ad,” June 15, 2007, available at <https://www.communitycatalyst.org/blog/bitter-pill-award-winner-lunesta-has-most-recalled-drug-ad-pal#.XNUZ3NM-zaRs> (last visited July 30, 2019).

T. B. Huedo-Medina , I. Kirsch , J. Middlemass , et al., “Effectiveness of Non-Benzodiazepine Hypnotics in Treatment of Adult Insomnia: Meta-Analysis of Data Submitted to the Food and Drug Administration,” BMJ 345 (2012): e8343, doi: 10.1136/bmj.e8343.

S. Rösner , C. Englbrecht , R. Wehrle , et al., “Eszopiclone for Insomnia, Cochrane Database of Systematic Reviews 10 (2018): Art. No.: CD010703, doi: 10.1002/14651858.CD010703 pub2.

A. Lundh , J. Lexchin , B. Mintzes , et al., “Industry Sponsorship and Research Outcome,” Cochrane Database of Systematic Reviews 2 (2017): Art. No.: MR000033, doi: 10.1002/14651858.MR000033.pub3.

UK National Institute of Clinical Excellence, “Hypnotics: Key Therapeutic Topics,” January 15, 2015, available at <https://www.nice.org.uk/advice/ktt6> (last visited July 30, 2019).

UK National Institute of Clinical Excellence, “Guidance on the Use of Zaleplon, Zolpidem and Zopiclone for the Shortterm Management of Insomnia,” (2004), available at <https://www.nice.org.uk/guidance/ta77/resources/guidance-on-theuse-of-zaleplon-zolpidem-and-zopiclone-for-the-shortterm-management-of-insomnia-pdf-2294763557317> (last visited July 30, 2019).

L. R. Pinto, Jr., L. R. A. Bittencourt , E. C. Treptow , et al., “Eszopiclone Versus Zopiclone in the Treatment of Insomnia,” Clinics 71, no. 1 (2016): 5-9.

See Kesselheim et al., supra note 1.

European Medicines Agency, “Pharmacovigilance Risk Assessement Committee (PRAC), PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Rev 1),” November 30, 2017, available at <https://www.ema.europa.eu/en/documents/other/prac-strategy-measuring-impact-pharmaco-vigilance-activities_en.pdf> (last visited July 30, 2019).

U. S. Food and Drug Administration, “Drug Safety Communication: FDA adds Boxed Warning for Risk of Serious Injuries Caused by Sleepwalking with Certain Prescription Insomnia Medicines,” April 30, 2019, available at <https://www.fda.gov/media/123819/download> (last visited July 30, 2019).