Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey

Abstract

Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Get full access to this article

View all access options for this article.

References

U.S. Food and Drug Administration, Drug Safety Communications, available at <http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm> (last visited August 1, 2019).

M. S.

Sinha ,

C. C.

Freifeld ,

J. S.

Brownstein ,

M. M.

Donneyong ,

Rausch ,

B. M.

Lappin ,

E. H.

Zhou ,

G.J.

Dal Pan ,

A. M.

Pawar ,

T. J.

Hwang ,

Avorn , and

A. S.

Kesselheim , “Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging about Zolpidem: Mixed-Methods Analysis,” JMIR: Public Health Surveillance 4, no. 1 (2018): e1, doi: 10.2196/publichealth.7823;

Woloshin ,

L. M.

Schwartz ,

S. Z.

Dejene ,

Rausch ,

G.J.

Dal Pan , and

A. S.

Kesselheim , “Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis,” Journal of Health Communication 22, no. 5 (2017): 365-372.

Food and Drug Administration, Drug Safety Communications, Feb. 25 2019, available at <http://www.fda.gov/Drugs/Drug-Safety/ucm199082.htm> (last visited August 1, 2019).

Valiyeva ,

Herrmann ,

P. A.

Rochon ,

S. S.

Gill , and

G. M.

Anderson , “Effect of Regulatory Warnings on Antipsychotic Prescription Rates Among Elderly Patients with Dementia: A Population-Based Time-Series Analysis,” CMAJ 179, no. 5 (2008): 438–446.

Wax ,

Doshi ,

Hossain ,

C. A.

Bodian ,

Krol , and

D. L.

Reich , “Changing Patterns of Postoperative Nausea and Vomiting Prophylaxis Drug use in an Academic Anesthesia Practice,” Journal of Clinical Anesthesia 19, no. 5 (2007): 356–359;

Cohen ,

Rabbani ,

Shah , et al., “Changes in Glitazone use Among Office-Based Physicians in the U.S., 2003–2009,” Diabetes Care 33 (2010): 823–825.

A. S.

Kesselheim ,

Donneyong ,

G.J.

Dal Pan ,

E. H.

Zhou ,

Avorn ,

Schneeweiss , and

J. D.

Seeger , “Changes in Prescribing and Healthcare Resource Utilization after FDA Drug Safety Communications Involving Zolpidem-Containing Medications,” Pharmacoepidemiology and Drug Safety 26, no. 6 (2017): 712-721.

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 August 1, 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 for Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist),” January 10, 2013, available at <http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm> (last visited August 1, 2019).

U. S. Food and Drug Administration, FDA Drug Safety Communication: FDA Warns of Next-Day Impairment with Sleep Aid Lunesta (Eszopiclone) and Lowers Recommended Dose,” available at <https://www.fda.gov/Drugs/DrugSafety/ucm397260.htm> (last visited August 1, 2019).

M. S.

Sinha ,

C. C.

Freifeld ,

J. S.

Brownstein ,

M. M.

Donneyong ,

Rausch ,

B. M.

Lappin ,

E. H.

Zhou ,

G.J.

Dal Pan ,

A. M.

Pawar ,

T. J.

Hwang ,

Avorn , and

A. S.

10.

Woloshin ,

L. M.

Schwartz ,

Dejene ,

Rausch ,

G.J.

Dal Pan ,

E. H.

Zhou , and

A. S.

Kesselheim , “Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis,” Journal of Health Communication 22, no. 5 (2017): 365-372.

11.

A. S.

Kesselheim ,

E. G.

Campbell ,

Schneeweiss ,

Rausch ,

B. M.

Lappin ,

E. H.

Zhou ,

J. D.

Seeger ,

J. S.

Brownstein ,

Woloshin ,

L. M.

Schwartz ,

Toomey ,

G.J.

Dal Pan , and

Avorn , “Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications,” Drug Safety 38, no. 6 (2015): 565-575.