Ambien (zolpidem), a popular sleep medication used to treat insomnia, may impair next-morning driving ability and increase the risk of car accidents, even in people who feel fully awake. This risk is different from sleep driving, another serious Ambien side effect. The risk of next-morning car accidents is significantly higher for women, who eliminate Ambien from their bodies more slowly than men. After receiving more than 700 reports of car accidents and other driving incidents, the FDA has cut the recommended dose of Ambien in half.
UPDATE: Lower Dose of Ambien Due to Next-Morning Car Accidents
January 10, 2013 — The U.S. Food and Drug Administration (FDA) has issued a new Safety Communication for all medications containing zolpidem, the active ingredient in Ambien and extended-release Ambien CR. The risk of impaired driving is greatest for women who take Ambien CR.
Doses of Ambien and Ambien CR will be lowered as follows:
- Ambien: Recommended dose will be lowered from 10mg to 5mg in women. Men can take either 5mg or 10mg.
- Ambien CR: Recommended dose will be lowered from 12.5 to 6.25mg in women. Men can take either 6.25mg or 12.5mg.
What is the problem with Ambien?
The problem with Ambien (zolpidem) is that the active drugs may impair driving ability for more than 8 hours after the initial dose. The risk information includes warnings about “drowsiness,” but it does not warn that people who feel fully awake may still have impaired driving ability.
According to the FDA:
“Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.”
The risk of impaired next-morning driving is also significantly higher for women. Although the warnings on other zolpidem-containing sleep drugs (such as Intermezzo) included extra warnings for women, the labels on Ambien do not contain these warnings.
Studies of Ambien Car Accidents
People with levels of Ambien in their blood above 50-ng/mL are at risk of impaired driving ability and car accidents. Researchers have studied what percentage of men and women have impairing levels of Ambien in their blood by giving 250 men and 250 women doses of Ambien and Ambien CR.
- Ambien (10-mg): 15% of women and 3% of men had at least 50-ng/mL of Ambien in their blood after 8 hours.
- Ambien CR (12.5-mg): 33% of women and 25% of men had at least 50-ng/mL of Ambien in their blood after 8 hours.
- 5% of patients who were given Ambien CR had at least 100-ng/mL of Ambien in their blood after 8 hours.