Zolpidem is a gamma-aminobutyric acid a receptor positive modulator sold in the U.S. under 7 brand and generic names, for sleep initiation and maintenance disorders. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Edluar (application NDA021997). Other zolpidem products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest dose effective for the patient ( 2.1 ) • Recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime. ( 2.1 ) • Geriatric patients and patients with hepatic impairment: Recommended dose is 5 mg for men and women. ( 2.2 ) • Lower doses of CNS depressants may be necessary when taken concomitantly with Edluar. ( 2.3 ) • Co-administration with CNS depressants: Recommended dose is 5 mg for men and women. ( 2.3 ) • The effect of Edluar may be slowed if taken with or immediately after a meal. ( 2.4 ) • Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. ( 2.4 ) • The tablet should not be swallowed and the tablet should not be taken with water. ( 2.4 ) 2.1 Dosage in Adults 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 (5.1) ] . The total dose of Edluar should not exceed 10 mg once daily immediately…
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] • CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] • Serious Anaphylactic and Anaphylactoid Reactions [see Warning and Precautions (5.4) ] • Abnormal Thinking and Behavioral Changes [see Warning and Precautions (5.5) ] • Withdrawal Effects [see Warning and Precautions (5.8) ] Most commonly observed adverse reactions were: Short term (< 10 nights): Drowsiness, dizziness, and diarrhea Long term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-444-7799 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Associated with discontinuation of treatment: Approximately 4% of 1,701 patients who received zolpidem tartrate 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%). Approximately 4% of 1,959 patients who received zolpidem tartrate at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LU;E62 | 12.5 mg | blue | round | — |
| 10MG | 10 mg | yellow | capsule | — |
| E;79 | 10 mg | white | oval | — |
| U4 | 7.5 mg | green, white | capsule | — |
| T | 6.25 mg | pink | round | — |
| Z | 12.5 mg | blue |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
The elimination half-life of zolpidem is about 2.5 hours (mean 2.5-2.6 hours; range roughly 1.4 to 4.5 hours) in healthy adults. All zolpidem metabolites are inactive, so no active metabolite extends its effect; however, the half-life is much longer in people with liver cirrhosis (about 10 hours, up to ~26) and modestly longer in adults over 70, so it varies by population.
ZOLPIDEM TARTRATE tablet, film coated — DailyMed (Clinical Pharmacology, Pharmacokinetics) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Edluar is contraindicated in patients: • who have experienced complex sleep behaviors after taking Edluar [see Warnings and Precautions (5.1) ]. • with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . • Patients who have experienced complex sleep behaviors after taking Edluar. ( 4 , 5.1 ) • Known hypersensitivity to zolpidem. ( 4 )
CNS-depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.1 , 7.1 ) • Imipramine: decreased alertness observed ( 7.1 ) • Chlorpromazine: impaired alertness and psychomotor performance observed ( 7.1 ) • Rifampin: combination use may decrease effects ( 7.2 ) • Ketoconazole: combination use may increase effect ( 7.2 ) 7.1 CNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1 , 5.2) ] . Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine, Chlorpromazine 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) ] . Haloperidol 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…
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