Zolpidem — Membership Pricing

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Also listed for Insomnia

• Doxepin
• Eszopiclone
• Melatonin
• Trazodone

Other medications in Sleep Disorders

• Armodafinil
• Modafinil

What Zolpidem is approved for (FDA label)

Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14) ] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Source: Read the full FDA label on DailyMed. Label effective date: September 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Zolpidem (FDA label)

WARNING: COMPLEX SLEEP BEHAVIORS 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 )] . WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. 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 ( 4 , 5.1 ).

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Zolpidem (FDA label)

5 mg and 10 mg tablets. Tablets not scored. Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored. Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side. Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side.

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Zolpidem (FDA label)

Most commonly observed adverse reactions were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28 to 35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma, Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch 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 Warnings and Precautions ( 5.4 )] Abnormal Thinking and Behavior Changes [see Warnings and Precautions ( 5.5 )] Withdrawal effects [see Warnings and Precautions ( 5.9 )] 6.1 Clinical Trials Experience Associated with Discontinuation of Treatment 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.

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Zolpidem (FDA label)

Patients who have experienced complex sleep behaviors after taking zolpidem tartare tablets ( 4 ) Known hypersensitivity to zolpidem ( 4 ) Zolpidem tartrate tablets are contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see Warnings and Precautions ( 5.1 )] . with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.4 )] .

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Zolpidem (FDA label)

CNS-Depressant Effects: Impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur.

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Zolpidem (FDA label)

CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.2 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 CNS-Active Drugs CNS Depressants 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 )]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.

Source: FDA prescribing information (DailyMed). Set ID: 1584bad1-7bf4-4805-bdd9-7eb0fac92721. SPL document ID: d9481da2-be07-4d0e-8316-9bea2dc953ce. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.