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77% of patients ignore FDA safety recommendations for Ambien

Thomas J. Moore

Most patients who use Ambien report sustained use despite the significant decline in efficacy after 14 days of continued use, according to a study published in JAMA Internal Medicine.

“[Ambien (zolpidem, Sanofi-Aventis)] was the most widely used prescription hypnotic medication and the fourth most frequently prescribed psychiatric drug in 2013,” Thomas J. Moore, AB, from the Institute for Safe Medication Practices, and Donald R. Mattison, MD, MS, from Risk Sciences International, wrote.

“However, the prescribing information and FDA Drug Safety Communications include limitations to reduce adverse effects, including short-term use because of loss of efficacy; a lower dose of 5 mg per day for those 65 years or older, and the lower starting dose for women because of 45% to 50% higher blood concentrations; and increased risks when combined with other central nervous system-depressant drugs,” they wrote.

Moore and Mattison assessed the characteristics and patterns of potentially unsafe use of zolpidem using data from the 2015 U.S. Medical Expenditure Panel Survey. The researchers defined sustained use of zolpidem as three or more prescriptions or 61 days or more of supply.

Data indicated that in 2015, 3.8 million adults aged 18 to 85 years were prescribed zolpidem one or more times. Zolpidem use almost doubled among women compared with men. Use of zolpidem increased with age.

The higher daily dose of zolpidem of 10 mg or 12.5 mg was prescribed to 64% of adults aged 65 years or older and 68% of women. Approximately 70% of individuals exposed to zolpidem reported sustained use as opposed to short-term use. Those in the sustained-use zolpidem group used a median of 192 days’ supply.

About 41% of zolpidem users also had sustained use of least one other central nervous system-depressant medication, such as opioids (26.5%) and benzodiazepines (20.3%). Most individuals (77.4%) did not follow two or more recommendations to reduce risk.

Moore told Healio Internal Medicine that physicians should observe the safety recommendations for this drug.

“It is effective only for short-term use; because women and the elderly have 45% to 50% higher blood levels, use the lower recommended dose; avoid multiple drugs that target the same gamma-aminobutyric acid receptors or depress the central nervous system; warn patients about next-day impairment that they may not be aware of can occur,” he said.

“The most important risks of zolpidem are next-day impairment of driving and other injury-prone activities, abnormal behavioral changes and dependence,” he added. “When 77% of patients report they are not observing two or more FDA recommendations for safe use, there is much to be done.” – by Alaina Tedesco

Disclosures: The authors report no relevant financial disclosures.