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What is Ambien?
Ambien is the brand name for zolpidem tartrate and it is a sedative-hypnotic. When you take Ambien according to your prescription, it can make you feel comfortable, relaxed and sleepy.
The United States Drug Enforcement Agency classifies Ambien as a Schedule IV drug, this means that it cannot be possessed or used without a prescription from a doctor.
The reason that the Drug Enforcement Agency monitors this drug is because it is potentially dangerous and habit forming in nature. Misuse of this medication can cause dependence and other potential side effects.
Those suffering with severe insomnia are the only authorised person who may take Ambien, and those patients must have to visit a doctor to obtain a prescription. Ambien is only prescribed for relief of insomnia for up to 35 days.
Side-effects of Ambien
The continuous use of Ambien may result in tolerance to desired effects. When this occurs, and rebound insomnia intensifies, people frequently resort to increasing the prescribed dose of medication – a practice that can result in some serious repercussions.
Depending on the time of night, and dose of Ambien that is being taken, residual effects of the drug may persist through the next day. Some users claim that these effects resemble a hangover from a night of heavy drinking. One can suffer from the following for several hours after waking the next morning:
- Memory loss.
- Persistent drowsiness.
- Gastrointestinal disturbances such as nausea.
Additionally, there are numerous reports of somnambulism (sleepwalking) and a bizarre phenomenon known as night eating syndrome—or sleep eating—that may occur, especially in the context of multiple doses.
Doctors refer to a specific disorder associated with the medication as paradoxical excitation, which refers to the way in which some individuals who have taken Ambien exhibit unusual behavior while using the drug; some people drive a car, eat or walk in a sleep state. They are not aware of their movements, and they won’t remember what happened—often, they do not find out until someone tells them when they are awake or they are faced with the consequences, e.g., finding out they’ve been in a car accident.
According to the U.S. National Library of Medicine, other side effects of Ambien include:
- Light headed feelings.
- Trouble walking.
- Problems with balance.
- Stomach cramps.
- Weak feelings.
- Appetite changes.
- Redness of the eyes.
- Joint pain.
- Muscle pain.
When to Consult a Doctor
The following signs and symptoms can indicate an allergic reaction or another condition that requires medical attention:
- Skin rash.
- Trouble breathing.
- Chest pain.
Ambien was evaluated in healthy subjects in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.
Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.
A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance.
A randomized, placebo-controlled, crossover interaction study in eight healthy female subjects between five consecutive daily doses of rifampin (600 mg) and a single dose of zolpidem (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (–73%), C max (–58%), and T1/2 (–36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem.
A randomized double-blind crossover interaction study in twelve healthy subjects showed that co-administration of a single 5 mg dose of zolpidem tartrate with ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased C max of zolpidem by a factor of 1.3 and increased the total AUC of zolpidem by a factor of 1.7 compared to zolpidem alone and prolonged the elimination half-life by approximately 30% along with an increase in the pharmacodynamic effects of zolpidem.
Caution should be used when ketoconazole is given with zolpidem and consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Ambien with ketoconazole may enhance the sedative effects.
Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
- A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.
- A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions.
- When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life.
- There was no evidence of an additive effect in psychomotor performance.
- A study involving cimetidine/zolpidem and ranitidine/zolpidem combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.
- Zolpidem had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in normal subjects.
One of the more serious effects of taking Ambien is developing a tolerance to the medication. If you have an increased tolerance to Ambien, you will notice that you need to frequently increase the size of your dosage if you want to feel the same effects that you did when you first took the drug.
Another long-term effect of Ambien is insomnia. Consequently, many sufferers increase the size of their doses as they become tolerant to the medication, which may lead to overdose.
An overdose may present as extreme drowsiness or loss of consciousness.
Can You Become Dependent?
Ambien dependence occurs more rapidly in those who abuse the drug, but it can also affect those who take the medication regularly as prescribed. With continued use, you can develop a dependence on the drug so that you don’t feel like you can function without it and you experience withdrawal when you try to stop.
Once dependence takes hold, it can be extremely difficult to stop using without help because of the potential severity of the withdrawal syndrome.
Ambien Effects and Reasons for Abuse
Next-day residual effects:
Next-day residual effects of Ambien were evaluated in seven studies involving normal subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of Ambien in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.
There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Ambien (zolpidem tartrate). There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg.
Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Ambien. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Ambien, predominantly at doses above 10 mg.
Effects on sleep stages:
In studies that measured the percentage of sleep time spent in each sleep stage, Ambien has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.