This week the FDA announced labeling changes lowering the recommended dosages for the sleep aid zolpidem (Ambien), after increasing reports of ED visits due to adverse reactions to the medication.

Since 2005, the number of zolpidem-related ED visits in the United States increased 220%, data from the Drug Abuse Warning Network (DAWN) indicate.

In 2010, females accounted for 68% of zolpidem-related ED visits. In January 2013, the FDA advised drug makers the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar and Zolpimist), and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). These changes became effective this week.

It has always been recommended elderly patients take a lower dose of medication, but many still receive doses that are too high. Patients aged 65 years and older represent about 32% of the visits to the ED department for adverse reactions, whereas 74 % are aged 45 years and older..

Adverse reactions to zolpidem include drowsiness, dizziness, hallucinations, behavioral changes and complex behaviors such as sleep driving, sleep walking and sleep sex. I have heard multiple stories from my patients about their experiences. Sleep-walking and sleep-eating are very common. I had one patient recount that she awoke to find that she had shaved off both her eyebrows during the night!

Look carefully at the medications your patients are taking before prescribing zolpidem, as 50% of related ED visits involved patients taking the medication in combination with other pharmaceuticals. Many patients are using other central nervous depressants, including alcohol,  and sedation can be dangerously enhanced.

Also remember, patients don’t always tell you everything they are taking or forget to bring their medication list with them. Be sure to ask if they take any medications that have made them feel sleepy, which can signify they may be taking a central nervous system depressant.

The insomnia patients I see often come to the clinic having been started on zolpidem before trying other sleep aids, such as sedating antidepressants. I suggest trying a step approach, as many patients do well with OTC melatonin. If this option is not helpful, consider trazodone or amitriptyline before starting zolpidem.

Remember sleep hygiene is the best medicine. Educate patients on what proper sleep hygiene entails. Provide educational materials that they can take home. This will help remind them what you have discussed in the office.

Problems with insomnia can also signify underlying sleep disorders. If you are not sure, please refer patients to your local sleep clinic for evaluation.

Sharon M. O’Brien, MPAS, PA-C, works at Presbyterian Sleep Health in Charlotte, N.C. Her main interest is helping patients understand the importance of sleep hygiene and the impact of sleep on health.

References

  1. Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality. Emergency Department Visits for Adverse Reactions Involving the Insomnia Medication Zolpidem. 1 May 2013. Accessed: 17 May 2013. Available at: http://www.samhsa.gov/data/2k13/DAWN079/sr079-Zolpidem.htm