Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.
Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.
The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Ambien is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema
What is AMBIEN?
AMBIEN is a sedative-hypnotic (sleep) medicine. AMBIEN is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:
• trouble falling asleep
• Take AMBIEN exactly as prescribed. Do not take more AMBIEN than prescribed for you.
• Take AMBIEN right before you get into bed.
• Do not take AMBIEN unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
• For faster sleep onset, AMBIEN should NOT be taken with or immediately after a meal.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much AMBIEN or overdose, call your doctor or poison control center right away or get emergency treatment.
After taking AMBIEN, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with AMBIEN.
Reported activities include:
• driving a car (“sleep-driving”)
• making and eating food
• talking on the phone
• having sex
Call your doctor right away if you find out that you have done any of the above activities after taking AMBIEN. Important:
- Take AMBIEN exactly as prescribed
• Do not take more AMBIEN than prescribed.
• Take AMBIEN right before you get in bed, not sooner
- Do not take AMBIEN if you:
• drink alcohol
• take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take AMBIEN with your other medicines.
• cannot get a full night’s sleep
How should I take AMBIEN?
After you stop taking sleep medicine, you may have symptoms for 1 to 2 days such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach-area pain. These are not all the side effects of AMBIEN. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.
General Information about AMBIEN
• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use AMBIEN for a condition for which it was not prescribed.
• Do not share AMBIEN with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about AMBIEN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AMBIEN that is written for healthcare professionals.
What are the ingredients in AMBIEN?
Active Ingredient: Zolpidem tartrate Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 5 mg tablet contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
What are the possible side effects of AMBIEN?
Serious side effects of AMBIEN include:
• getting out of bed while not being fully awake and do an activity that you do not know you are doing.
• abnormal thoughts and behavior.
Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• memory loss
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking AMBIEN. Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using AMBIEN. The most common side effects of AMBIEN are:
• diarrhea • “drugged feelings”
• You may still feel drowsy the next day after taking AMBIEN. Do not drive or do other dangerous activities after taking AMBIEN until you feel fully awake.
Who should not take AMBIEN?
Do not take AMBIEN if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in AMBIEN. AMBIEN may not be right for you. Before starting AMBIEN, tell your doctor about all of your health conditions, including if you:
• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take AMBIEN with other medicines that can make you sleepy. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
DOSAGE FORMS AND STRENGTHS
The dose of Ambien should be individualized. Ambien is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored. Ambien 5 mg tablets are capsule-shaped, pink, film-coated, with AMB 5 debossed on one side and 5401 on the other. Ambien 10 mg tablets are capsule-shaped, white, film-coated, with AMB 10 debossed on one side and 5421 on the other. The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
Use in patients with depression:
As with another sedative/hypnotic drugs, Ambien should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
Use in pediatric patients:
Safety and effectiveness of zolpidem have not been established in pediatric patients. In an 8-week study in pediatric patients (aged 6-17 years) with insomnia associated with ADHD, zolpidem did not decrease sleep latency compared to placebo. Hallucinations were reported in 7.4% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations
DRUG ABUSE AND DEPENDENCE
Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo. Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.
Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms to range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less.
Signs and symptoms
In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.
Recommended treatment general symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem’s sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms