Zolpidem

Generic name: zolpidem tartrate · Brand names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

Quick facts

Drug class
The label calls zolpidem a GABA A receptor positive modulator. MedlinePlus calls it a sedative-hypnotic.
Section
Highlights, Indications and Usage; Description 11 (imidazopyridine class)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Rx or otc
Rx (label is a prescription label; Medication Guide dispensed) - source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Controlled schedule
Section
9.1 Controlled Substance
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Zolpidem Tartrate is classified as a Schedule IV controlled substance by federal regulation.
Forms and strengths
  • Tablets, 5 mg and 10 mg. Tablets are not scored. (3 DOSAGE FORMS AND STRENGTHS)
  • Acme 5 mg: pink film coated, round biconvex tablets, debossed "IT 117" on one side; 10 mg: white film coated, round biconvex tablets, debossed "IT 118" on one side. (3)
Generic available
Value
yes - this page is based on a generic (labeler ACME Laboratories, tablet, film coated; marketing category not read from label text; DailyMed list shows many zolpidem tartrate tablet labelers)
Source
https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=zolpidem
Common use one line
Short-term treatment of insomnia with difficulty falling asleep (label Indications).

What it is used for

Zolpidem is used for a short time to treat insomnia when it is hard to fall asleep. In controlled studies it shortened the time to fall asleep for up to 35 days. It is the generic of Ambien.
Section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].

How it works

Zolpidem acts on GABA A receptors in the brain. This is thought to calm nerve activity and help sleep.
Section
12.1 Mechanism of Action
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

Dosage: adults

The label says to use the lowest dose that works. The starting dose is 5 mg for women and 5 or 10 mg for men. Take it once a night right before bed, with at least 7-8 hours left to sleep. Do not take more than 10 mg a day and do not take a second dose the same night.
Section
2.1 Dosage in Adults
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Use the lowest effective dose for the patient. 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)]. The total dose of Zolpidem Tartrate Tablets should not exceed 10 mg once daily immediately before bedtime. Zolpidem Tartrate Tablets should be taken as a single dose and should not be readministered during the same night.

Dosage: children

Zolpidem is not recommended for children. Safety and effectiveness are not established under 18 years.
Section
8.4 Pediatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Zolpidem Tartrate Tablets is not recommended for use in children. Safety and effectiveness of Zolpidem in pediatric patients below the age of 18 years have not been established.

Dosage adjustments

Drug interaction caps
The dose may need to change if zolpidem is used with other drugs that slow the brain.
Section
2.3 Use with CNS Depressants
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Dosage adjustment may be necessary when Zolpidem Tartrate Tablets is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.2, 5.7)].
Kidney
Section
n/a
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Liver
With mild to moderate liver problems the dose is 5 mg once daily at bedtime. Avoid zolpidem with severe liver problems.
Section
2.2 Special Populations
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem Tartrate Tablets in these patients is 5 mg once daily immediately before bedtime. Avoid Zolpidem Tartrate Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.8), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Elderly
Older or weakened patients may be extra sensitive. The dose is 5 mg once daily at bedtime.
Section
2.2 Special Populations
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem tartrate. The recommended dose of Zolpidem Tartrate Tablets in these patients is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.2), Use in Specific Populations (8.5)].

Missed dose

Zolpidem is taken as needed. You can take it later than usual only if you can stay in bed for the required number of hours.
Section
What should I do if I forget a dose?
Source
https://medlineplus.gov/druginfo/meds/a693025.html
Label note
The DailyMed label has no missed-dose section
Source text (exact source wording)
This medication is taken as needed. You may take zolpidem even if it is later than the usual time, as long as you will be able to remain in bed for the required number of hours after you take it.

Overdose

Label
Overdose can cause anything from sleepiness to coma, heart or breathing problems, and death.
Section
10.1 Signs and Symptoms
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
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.
Medlineplus
For an overdose call poison control at 1-800-222-1222. Call 911 if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.
Source
https://medlineplus.gov/druginfo/meds/a693025.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Store at room temperature, 20°C-25°C (68°F-77°F). This is the Acme label detail; other labelers may differ. MedlinePlus also says to keep it in the original tightly closed container away from heat, light and moisture.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Store at controlled room temperature 20°C-25°C (68°F-77°F).

Boxed warning

Zolpidem can cause sleep-walking, sleep-driving and other activities while not fully awake. These events can cause serious injury, including death. Stop zolpidem right away if this happens.
Section
WARNING: COMPLEX SLEEP BEHAVIOUR (heading as printed in this label's full prescribing information)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Tablets. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)].

Contraindications

Do not use zolpidem if you ever had a complex sleep behavior after taking it.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [see Warnings and Precautions (5.1)]
Do not use zolpidem if you are allergic to it. Reactions seen include anaphylaxis and angioedema.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)]

Warnings and precautions

Sleep-walking, sleep-driving and other activities while not fully awake can happen with the first dose or any later dose. People can be hurt or die, and usually do not remember. Stop the drug right away if it happens.
Heading
5.1 Complex Sleep Behaviors
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
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 Zolpidem Tartrate Tablets. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with Zolpidem Tartrate Tablets alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interaction (7.1)]. Discontinue Zolpidem Tartrate Tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4)].
Next-day driving problems are more likely with less than 7 to 8 hours of sleep left, a higher dose, alcohol or other CNS depressants.
Heading
5.2 CNS-Depressant Effects and Next-Day Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpidem Tartrate Tablets is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if Zolpidem Tartrate Tablets is taken in these circumstances [see Dosage and Administration (2), Clinical Studies (14.3)]
If insomnia does not go away after 7 to 10 days, another medical or mental health problem may be present.
Heading
5.3 Need to Evaluate for Comorbid Diagnoses
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
Swelling (angioedema) can happen. Anyone who has it should not take zolpidem again.
Heading
5.4 Severe Anaphylactic and Anaphylactoid Reactions
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.
Behavior and thinking changes, including agitation and hallucinations, have been reported.
Heading
5.5 Abnormal Thinking and Behavioral Changes
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including Zolpidem Tartrate Tablets. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported.
Depression and suicidal thoughts can get worse.
Heading
5.6 Use in Patients with Depression
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported.
Breathing problems are a concern in people with sleep apnea, myasthenia gravis or who use opioids.
Heading
5.7 Respiratory Depression
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
The risk of respiratory depression should be considered prior to prescribing Zolpidem Tartrate Tablets in patients with respiratory impairment including sleep apnea and myasthenia gravis or with concomitant opioid use [see Dosage and Administration (2.3), Drug Interactions (7.1)].
Avoid zolpidem with severe liver impairment.
Heading
5.8 Precipitation of Hepatic Encephalopathy
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Avoid Zolpidem Tartrate Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]
Withdrawal symptoms can follow a rapid dose decrease or sudden stop.
Heading
5.9 Withdrawal Effects
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and Dependence (9.2, 9.3)]

Pregnancy and breastfeeding

Pregnancy
Babies born to mothers who used zolpidem late in the third trimester have had breathing slowdown and sedation.
Section
8.1 Pregnancy
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Neonates born to mothers using Zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data].
Lactation
A nursing mother may pump and discard milk during treatment and for 23 hours after a dose. Infants should be watched for too much sleepiness.
Section
8.2 Lactation
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after Zolpidem Tartrate Tablets administration in order to minimize drug exposure to a breast fed infant.

Side effects

Common
In short-term use (up to 10 nights), the most common reactions were drowsiness (2%), dizziness (1%) and diarrhea (1%). In longer use (28 to 35 nights) they were dizziness (5%) and drugged feelings (3%).
Threshold
The label does not state a numeric threshold for its most-commonly-observed list; it lists reactions seen at statistically significant differences from placebo.
Section
6.1 Most Commonly Observed Adverse Reactions in Controlled Trials
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
During short-term treatment (up to 10 nights) with Zolpidem Tartrate Tablets at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of Zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of Zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with Zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of Zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).
Less common
Other reactions in the label tables include headache (7% vs 6% placebo in short trials), and in the longer trials dry mouth, allergy, back pain, palpitations, lethargy, depression, rash, sinusitis and others at 1% to 8%.
Section
6.1 Tables 1 and 2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Table 1 (up to 10 nights; Zolpidem <=10 mg N=685 vs Placebo N=473, percent): Headache 7 vs 6; Drowsiness 2 vs -; Dizziness 1 vs -; Diarrhea 1 vs -. Table 2 (up to 35 nights; Zolpidem <=10 mg N=152 vs Placebo N=161): Dry mouth 3 vs 1; Allergy 4 vs 1; Back Pain 3 vs 2; Influenza-like symptoms 2 vs -; Chest pain 1 vs -; Palpitation 2 vs -; Drowsiness 8 vs 5; Dizziness 5 vs 1; Lethargy 3 vs 1; Drugged feeling 3 vs -; Lightheadedness 2 vs 1; Depression 2 vs 1; Abnormal dreams 1 vs -; Amnesia 1 vs -; Sleep disorder 1 vs -; Diarrhea 3 vs 2; Abdominal pain 2 vs 2; Constipation 2 vs 1; Sinusitis 4 vs 2; Pharyngitis 3 vs 1; Rash 2 vs 1. (Table rows transcribed from the label tables; the table header text is: Reactions reported by at least 1% of patients treated with Zolpidem Tartrate Tablets and at a greater frequency than placebo.)
Serious
Label
Serious label items: complex sleep behaviors, next-day impairment, severe allergic reactions, abnormal thinking and behavior, withdrawal effects, liver injury and delirium (postmarketing).
Section
6 ADVERSE REACTIONS; 6.2 Postmarketing Experience
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Complex Sleep Behaviors [see Warnings and Precautions (5.1)]; CNS-depressant effects and next-day impairment [see Warnings and Precautions (5.2)]; Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.4)]; Abnormal thinking and behavior changes [see Warnings and Precautions (5.5)]; Withdrawal effects [see Warnings and Precautions (5.9)]. Postmarketing: Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin >2 × ULN, alkaline phosphatase ≥2 × ULN, transaminase ≥5 × ULN). Psychiatric disorders: delirium
Medlineplus
MedlinePlus says to call your doctor right away for these symptoms.
Section
What side effects can this medication cause?
Source
https://medlineplus.gov/druginfo/meds/a693025.html
Source text (exact source wording)
rash; hives; itching; swelling of the eyes, face, lips, tongue, or throat; feeling that the throat is closing; difficulty breathing or swallowing; hoarseness; shortness of breath; yellow eyes or skin; light-colored stools; nausea; vomiting; pounding heartbeat; chest pain; blurred vision or other vision problems
Led to discontinuation
About 4% of 1,701 patients in U.S. trials stopped because of a side effect. Reasons included daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%) and vomiting (0.5%).
Section
6.1 Associated with Discontinuation of Treatment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Approximately 4% of 1,701 patients who received Zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Interactions

Drugs
Using zolpidem with other CNS depressants raises the risk of drowsiness and impaired driving.
Name
CNS depressants (including opioids, benzodiazepines)
Section
7.1 CNS-Active Drugs
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Coadministration of Zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of Zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions (5.1, 5.2)].
Using opioids with zolpidem may raise the risk of slowed breathing. Dose and length of combined use should be limited.
Name
Opioids
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
The concomitant use of Zolpidem Tartrate Tablets with opioids may increase the risk of respiratory depression. Limit dosage and duration of concomitant use of Zolpidem Tartrate Tablets and opioids [see Dosage and Administration (2.3), Warnings and Precautions (5.7)]
Taking these with zolpidem added to decreased alertness.
Name
Imipramine, chlorpromazine
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
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. Similarly, chlorpromazine in combination with Zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology (12.3)].
Sertraline raises zolpidem exposure.
Name
Sertraline
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Concomitant administration of Zolpidem and sertraline increases exposure to Zolpidem [see Clinical Pharmacology (12.3)].
Fluoxetine raised the zolpidem half-life by 17% with no added effect on psychomotor performance.
Name
Fluoxetine
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
After multiple doses of Zolpidem Tartrate and fluoxetine an increase in the Zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology (12.3)].
Rifampin lowers zolpidem exposure and effect. The combination is not recommended.
Name
Rifampin
Section
7.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of Zolpidem. Use of Rifampin in combination with Zolpidem may decrease the efficacy of Zolpidem and is not recommended [see Clinical Pharmacology (12.3)].
Ketoconazole raises zolpidem exposure. A lower zolpidem dose should be considered.
Name
Ketoconazole
Section
7.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of Zolpidem. Consideration should be given to using a lower dose of Zolpidem when a potent CYP3A4 inhibitor and Zolpidem are given together [see Clinical Pharmacology (12.3)].
No effect of haloperidol was seen after a single dose.
Name
Haloperidol
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
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 the absence of an effect following chronic administration [see Clinical Pharmacology (12.3)].
Food and alcohol
Alcohol adds to the effect of zolpidem on coordination and thinking.
Name
Alcohol
Section
7.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
An additive adverse effect on psychomotor performance between alcohol and oral Zolpidem was demonstrated [see Warnings and Precautions (5.1, 5.2)]
Zolpidem may work more slowly if taken with or right after a meal.
Name
Food (meal)
Section
2.4 Administration
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
The effect of Zolpidem Tartrate Tablets may be slowed by ingestion with or immediately after a meal.
Other
St. John's wort may lower zolpidem levels and is not recommended.
Name
St. John's wort
Section
7.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Source text (exact source wording)
Use of St. John's wort, a CYP3A4 inducer, in combination with Zolpidem may decrease blood levels of Zolpidem and is not recommended.

Patient tips

Medlineplus
Take it right before bed, when you can stay in bed 7 to 8 hours. Avoid alcohol. Do not take more than prescribed. Do not stop suddenly without talking to your doctor. Call your doctor if sleep does not improve in 7 to 10 days.
Section
How should this medicine be used? / What special precautions should I follow?
Source
https://medlineplus.gov/druginfo/meds/a693025.html
Source text (exact source wording)
Zolpidem will work faster if it is not taken with a meal or immediately after a meal. ... Plan to go to bed right after you take zolpidem tablets, extended-release tablets, sublingual tablets (Edluar), and oral spray and to stay in bed for 7 to 8 hours. ... do not drink alcohol during your treatment with zolpidem. Alcohol can make the side effects of zolpidem worse. ... Do not stop taking zolpidem without talking to your doctor, especially if you have taken it for longer than 2 weeks. ... Zolpidem may be habit forming. Do not take a larger dose of zolpidem, take it more often, or take it for a longer time than prescribed by your doctor. ... Your sleep problems should improve within 7 to 10 days after you start taking zolpidem. Call your doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment. (Ellipses join separate sentences from the same page.)

Alternatives

Class from label
gamma-aminobutyric acid (GABA) A receptor positive modulator (label Indications); imidazopyridine class (label Description)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display

Frequently asked questions

Question
What is zolpidem used for?
Answer
It is used for short-term treatment of insomnia when it is hard to fall asleep. In controlled studies it shortened the time to fall asleep for up to 35 days.
Source section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Question
How should I take zolpidem?
Answer
Take it once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. The effect may be slowed if taken with or right after a meal.
Source section
2.1 and 2.4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Question
What is the maximum dose?
Answer
The total dose should not exceed 10 mg once daily. The starting dose is 5 mg for women and 5 or 10 mg for men.
Source section
2.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Question
What if I miss a dose?
Answer
Zolpidem is taken as needed. MedlinePlus says you may take it later than usual only if you can stay in bed for the required number of hours.
Source section
What should I do if I forget a dose?
Source
https://medlineplus.gov/druginfo/meds/a693025.html
Question
Can I drink alcohol with zolpidem?
Answer
MedlinePlus says not to drink alcohol during treatment. The label says alcohol adds to the effect on psychomotor performance.
Source section
7.1 Alcohol; MedlinePlus precautions
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display ; https://medlineplus.gov/druginfo/meds/a693025.html
Question
What are the common side effects?
Answer
In short-term use (up to 10 nights) the most common were drowsiness (2%), dizziness (1%) and diarrhea (1%). In longer use (28 to 35 nights) they were dizziness (5%) and drugged feelings (3%).
Source section
6.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Question
Is zolpidem safe in pregnancy or while breastfeeding?
Answer
Babies born to mothers who used zolpidem late in the third trimester have had breathing slowdown and sedation. A nursing mother may pump and discard milk during treatment and for 23 hours after a dose.
Source section
8.1, 8.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display
Question
What is the sleep-walking warning?
Answer
Zolpidem can cause sleep-walking, sleep-driving and other activities while not fully awake, which can cause serious injury or death. Stop it right away and call your doctor if this happens.
Source section
Boxed warning; 5.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5679ed64-8424-4e63-a3c9-91d80fff2ca6&type=display

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug