Author: James Anderson

Zolpidem Ambien: Uses & Side Effects

The effects of this drug can last even after you wake up the next day. If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive. You may also experience dizziness or blurred/double vision. Alcohol or marijuana (cannabis) can make you more dizzy.

Patients should be counseled to take AMBIEN right before they get into bed and only when they are able to stay in bed a full night (7–8 hours) before being active again. AMBIEN tablets should not be taken with or immediately after a meal. Advise patients NOT to take AMBIEN if they drank alcohol that evening. Infants exposed to AMBIEN through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation.

Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. It is better to take this medication on an empty stomach and only when you are ready for bed. If you have been taking this medication for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness.

This can include setting an alarm or downloading a reminder app on your phone. Do not crush, chew, or split Ambien CR tablets, as this can affect how the drug works. If you have trouble swallowing tablets, see this article for tips on how to take this form of medication. If you’re age 65 years or older, your doctor will likely prescribe a lower dosage of Ambien for you.

1. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem.
2. Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects.
3. Take this medication by mouth on an empty stomach as directed by your doctor, usually once a night.
4. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.

Advise patients that use of AMBIEN late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used AMBIEN during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations (8.1)]. Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4)]. The dose of AMBIEN in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.2)].

Generic Name(S): zolpidem

There was no evidence of an additive effect in psychomotor performance. Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of AMBIEN. Patients can be seriously injured or injure others during complex sleep behaviors. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior [see Contraindications (4)].

The following adverse reactions have been identified during postapproval use of AMBIEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. It helps you get to sleep faster and stay asleep throughout the night. If you need to stop taking Ambien or Ambien CR, your doctor will slowly lower your dosage to help you avoid withdrawal symptoms.

As a result, many people with depression take sedatives such as Ambien. 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 this medicine for longer than 4 or 5 weeks without your doctor’s advice. 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.

Are you currently using Ambien?

The inner layer dissolves more slowly and helps you stay asleep. But this inner layer can also mean blood levels of the drug are still high enough the next morning to impair your ability to drive or operate machinery. The FDA regularly monitors prescription drug information and makes label changes based on reported side effects.

Instruct patients and their families that AMBIEN may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue AMBIEN and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions (5.1)].

Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN is taken in these circumstances [see Dosage and Administration (2), Clinical Studies (14.3)]. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.2)].

2 Drugs that Affect Drug Metabolism via Cytochrome P450

Do not increase your dose, take it more often, or use it for longer than prescribed. Women are usually prescribed a lower dose because the drug is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects. Impairment with Ambien CR is increased with higher dosages; when taking it late at night with less than 7 to 8 hours of sleep left; in women; and if taken with narcotic pain medicines, antidepressants, or alcohol. If you still feel drowsy the next day after taking Ambien CR, talk to your doctor about reducing the dosage or alternative sleep medications. Do not attempt to do anything that requires alertness if you are not fully awake after taking Ambien CR.

Controlled substance status also means government agencies, doctors, and pharmacists pay close attention to how the drug’s prescribed and used. Your doctor will assess your risk of misuse and addiction before prescribing this drug for you. You’re more likely to experience misuse or addiction if you have a mental health condition or have misused drugs or alcohol in the past. The recommended dosage of Ambien for adults ages 65 years and older is 5 mg once daily before bedtime. The recommended dosage of Ambien CR for people in this age group is 6.25 mg once daily before bedtime.

Zolpidem (Oral Route)

Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of AMBIEN. 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. A single-dose interaction study with zolpidem tartrate 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 were given at steady state and the concentrations evaluated in healthy females, an increase in the zolpidem half-life (17%) was observed.