Adding plans allows you to compare formulary status to other drugs in the same class. Drug information contained herein may be time sensitive. Zolpidem 10 mg-TEV, white, round, film coated. Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma. GABA A receptor positive modulators. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
The data also suggest that the labeling change may have served as a reminder to prescribe the lowest zolpidem dose possible in all patients. This was illustrated in a study describing simvastatin prescribing patterns before and after FDA-mandated dosing restrictions. By following governmental dosing recommendations closely, providers may have prevented patients from sustaining adverse reactions.
Although there is no demonstrated difference in zolpidem safety or efficacy based on gender, 10 , 11 evidence suggests there is a doseóresponse relationship with zolpidem adverse events, supporting the rationale to prescribe the lowest effective dose of zolpidem for a short duration. The authors found the HR increased as the mean dose of zolpidem per year increased, supporting a doseóresponse relationship. In addition to an increased risk of head injury and fracture, zolpidem has also been associated with increased automobile crashes due to hangover sedation.
The study found new users of all three sedatives were at an increased risk of crash relative to nonusers. The risk estimates are equivalent to the risk while driving with BACs between 0. In fact, this could cause more accidents by giving patients the false sense that they will know when they are capable of driving.
While there is an increased risk of automobile crashes potentially due to hangover sedation from zolpidem, there are also data that associate sleepiness with decreased driving performance and increased risk of automobile crashes. To our knowledge, there are no published studies comparing the safety of zolpidem and the incidence of adverse effects before and after the labeling change.
Limitations of this study are largely due to its retrospective nature. We were not able to determine whether clinical decisions regarding the appropriate initial zolpidem dose for a patient were due to knowledge of the FDA safety announcement and zolpidem labeling change in or due to other patient-specific factors.
Second, this study had a relatively small sample size and only large differences in the proportion of patients prescribed low-dose zolpidem were expected to reach statistical significance. Another potential limitation is that the data were gathered retrospectively from electronic health records. We were unable to gather any ED data from other hospitals in our area, so the incidence of ED visits is likely underestimated. Moreover, the adverse event data are hypothesis generating only and cannot be used to draw conclusions regarding the safety of zolpidem.
Furthermore, we cannot prove any of the previously discussed adverse events were caused by zolpidem given the retrospective nature of the study. Finally, we were not able to collect evidence e. Patients may have taken more zolpidem than prescribed, which could have precipitated their adverse events. Future research is needed to further examine the effect of the labeling changes and the impact on clinical outcomes. Our population was within an academic medical center where updated evidence is easily disseminated to providers, so our results may not be generalizable to all practice settings.
Larger cohorts and the use of prescription claims data and patient interviews are needed to determine if the labeling changes have truly affected the safety or efficacy of zolpidem products in young women. Within the University of Colorado Health system, the percentage of new zolpidem prescriptions initiated at a low dose significantly increased after the FDA required labeling change. However, consistent with the specifics of the labeling change, when subgroups were evaluated only the subgroup of young women had a statistically significant increase in low-dose zolpidem prescriptions after the labeling change.
Declaration of conflicting interests: Informed consent was not sought for this study because it was retrospective. National Center for Biotechnology Information , U. Published online May 5. Received Dec 14; Accepted Apr Zolpidem, insomnia, sleep initiation and maintenance disorders, United States Food and Drug Administration, drug safety. Background Zolpidem is the most widely prescribed sedative-hypnotic in the United States.
Characteristics of the study population before and after the zolpidem labeling change. Discussion Zolpidem prescribing practices in our health system appeared to be affected by the FDA drug safety communication and updated zolpidem label in Conclusion Within the University of Colorado Health system, the percentage of new zolpidem prescriptions initiated at a low dose significantly increased after the FDA required labeling change.
Footnotes Declaration of conflicting interests: Pharmacokinetic properties of zolpidem in elderly and young adults: Br J Clin Pharmacol ; Gender differences in pharmacokinetics and pharmacodynamics of zolpidem following sublingual administration. J Clin Pharmacol ; Zolpidem and driving impairmentóidentifying persons at risk.
N Engl J Med ; Food and Drug Administration. FDA 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 , http: Simvastatin prescribing patterns before and after FDA dosing restrictions: Am J Cardiovasc Drugs ; Roehrs TA, Roth T. Gender differences in the efficacy and safety of chronic nightly zolpidem. J Clin Sleep Med ; It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States.
Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of this medicine purchased on the Internet have been found to contain haloperidol Haldol , a potent antipsychotic drug with dangerous side effects. For more information, contact the U. Take zolpidem exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take zolpidem in larger amounts, or for longer than prescribed.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Zolpidem may be habit-forming. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
Selling or giving away this medicine is against the law. Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again. Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active. Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.
Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice. Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine. Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medicine. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water. Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days. Store at room temperature away from moisture and heat.
Keep the Zolpimist bottle upright when not in use. Dosage Information in more detail. Seek emergency medical attention or call the Poison Help line at An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness. Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma. You may still feel sleepy the morning after taking zolpidem, especially if you take the extended-release tablet, or if you are a woman.
Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia forgetfulness is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.
Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to zolpidem: Report any new or worsening symptoms to your doctor, such as: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Side effects in more detail. Use the lowest dose possible to minimize the risk of next day impairment of activities that require full alertness.
For the short-term treatment of insomnia characterized by difficulties with sleep initiation: