Medications Directory

Approved indications: Oral zolpidem tartrate (immediate- and extended-release tablets and related oral forms) is FDA-approved in adults for the short-term treatment of insomnia, including difficulty falling asleep, and for some formulations also difficulty staying asleep or returning to sleep after a middle-of-the-night awakening.

Off-label uses: Clinicians sometimes use zolpidem off label for conditions such as disorders of consciousness after brain injury, catatonia, and certain movement or other neurological disorders; evidence comes mainly from case reports and small series, so responses are unpredictable and these uses are not considered standard care.

Efficacy expectations: Many people notice benefit with the first dose, typically falling asleep faster and waking less often, with modest improvements (on the order of tens of minutes) in total sleep time; benefits last only while the drug is taken, so insomnia often returns when it is stopped unless underlying sleep problems are addressed.

Comparison to similar drugs: Zolpidem provides insomnia relief comparable to other “Z-drugs” and benzodiazepine sleeping pills, with a relatively short half-life that can lessen, but not eliminate, next-day sedation, and overall offers similar effectiveness but shares class risks such as dependence, withdrawal, and complex sleep behaviors.

Typical dosing by age and liver function: For immediate-release tablets, the usual adult starting dose is 5 mg at bedtime for women and 5–10 mg for men, taken once nightly with at least 7–8 hours available for sleep; for extended-release tablets, typical starting doses are 6.25 mg for women and 6.25–12.5 mg for men once nightly, while adults 65 years or older or those with mild to moderate hepatic impairment generally use a maximum of 5 mg (immediate-release) or 6.25 mg (extended-release) at bedtime, and use is avoided in severe hepatic impairment.

How to take: Take zolpidem only right before going to bed when you can stay in bed for a full night, on an empty stomach or at least several hours after a meal to help it work quickly, swallow tablets whole with water (do not crush, split, or chew extended-release forms), and never take more than one dose in a single night.

Special dosing instructions: Treatment is usually limited to a short period (often a few days to a few weeks) while underlying causes of insomnia are evaluated and non-drug sleep measures are optimized; the dose should not be increased, taken earlier, or continued long term without medical review because of the risks of tolerance, dependence, and complex sleep behaviors.

Missed dose and overdose: Because zolpidem is taken at bedtime as needed, if you forget or decide not to take it, simply skip the dose—do not take an extra dose later in the night or double up the next evening; in case of suspected overdose, especially if combined with alcohol, opioids, or other sedatives, seek emergency medical care or contact poison control immediately.

Common side effects: The most frequent effects are drowsiness, dizziness, headache, diarrhea, and a “drugged,” groggy, or unsteady feeling, usually beginning in the first nights of use and often mild to moderate; next-morning sleepiness or slowed thinking is more likely with higher doses, extended-release tablets, in women and older adults, and when taken with or soon after food.

Serious adverse effects needing urgent care:

• Complex sleep behaviors such as sleepwalking, sleep driving, eating, or other activities while not fully awake, especially if injury occurs or there is no memory of the event.
• Severe allergic reactions, including swelling of the face, lips, tongue, or throat, trouble breathing, or a severe rash.
• Marked confusion, agitation, hallucinations, aggressive or abnormal behavior, suicidal thoughts or actions, or signs of overdose such as extreme drowsiness, very slow or difficult breathing, or inability to awaken.

Warnings and precautions: Zolpidem carries a Boxed Warning for complex sleep behaviors and is contraindicated in anyone who has previously had such an episode with zolpidem or related drugs; use the lowest effective dose, avoid alcohol and other sedatives, and use particular caution in older adults, people with depression or other mental health conditions, substance use disorders, respiratory disease (such as COPD or sleep apnea), or liver impairment, and avoid use in severe hepatic impairment and in children or adolescents.

Pregnancy and breastfeeding: Zolpidem crosses the placenta and late-pregnancy use has been associated with newborn sedation, breathing problems, and low muscle tone, so in pregnancy it is generally reserved for situations where potential benefits clearly outweigh risks; it passes into breast milk in small amounts, so nursing infants should be monitored for unusual sleepiness, poor feeding, limpness, or breathing difficulties.

Relative safety: Compared with many older benzodiazepine sleeping pills, zolpidem tends to cause less daytime muscle relaxation and has a shorter half-life, but it still poses important risks of dependence, withdrawal symptoms if stopped abruptly, falls, cognitive impairment, and overdose when combined with other central nervous system depressants.

Side-effect reporting and safety updates: Suspected side effects should be reported to the prescribing clinician and to the FDA MedWatch program (online or by phone), and patients should review the Medication Guide and FDA website for current safety communications and updated warnings about zolpidem-containing products.

Other medicines and substances: Zolpidem’s sedative effects are increased by alcohol, cannabis, opioids, benzodiazepines, other sleep medicines, many antipsychotics and antidepressants, anticonvulsants, and sedating antihistamines, which can lead to profound drowsiness, breathing problems, falls, and overdose, so these combinations are generally avoided or used only with cautious dose adjustment and close monitoring.

Metabolism interactions: Zolpidem is mainly broken down by liver enzyme CYP3A4, so strong inhibitors (such as ketoconazole, some macrolide antibiotics, and certain HIV or hepatitis C antivirals) can raise blood levels and increase sedation, while inducers (such as rifampin and St. John’s wort) can reduce its effect; some antidepressants (for example sertraline, fluvoxamine, bupropion, venlafaxine) and ciprofloxacin may also alter levels or increase the risk of hallucinations or other central nervous system effects.

Conditions requiring caution or avoidance: Use with particular caution, or avoid, in people with severe liver disease, significant chronic lung disease or sleep apnea, myasthenia gravis, a history of complex sleep behaviors with any Z-drug, current or past substance use disorder, serious depression or suicidal thoughts, or in older adults prone to falls, confusion, or cognitive impairment.

Monitoring needs: Routine blood tests or ECGs are not usually required, but clinicians typically monitor for sleep improvement, next-day impairment (including driving safety), mood or behavior changes, signs of misuse, abuse, or dependence, respiratory status when combined with other CNS depressants or in patients with lung disease, and liver function if there is known hepatic impairment.

Q: How long can I safely take zolpidem tartrate?
A: It is intended mainly for short-term use (usually a few days to a few weeks) while underlying sleep problems are addressed, and any longer-term use should be closely supervised by a clinician with regular attempts to taper or stop.

Q: Can I drink alcohol while taking zolpidem?
A: No; alcohol greatly increases zolpidem’s sedative and breathing-depressant effects and raises the risk of dangerous complex sleep behaviors, accidents, and overdose.

Q: Will zolpidem affect my driving or work the next day?
A: Zolpidem can cause next-day drowsiness and slower reaction time, especially with higher doses, extended-release tablets, in women or older adults, or if taken too late at night or with other sedatives, so you should not drive or do tasks requiring full alertness unless you are sure you feel completely awake.

Q: Is zolpidem habit-forming or addictive?
A: Zolpidem is a Schedule IV controlled substance and can cause tolerance, dependence, and withdrawal symptoms if used at higher doses or for long periods, so it should be used at the lowest effective dose for the shortest time and never shared with others.

Q: What happens if I stop zolpidem suddenly after using it for a while?
A: Some people experience rebound insomnia, anxiety, restlessness, or other withdrawal-like symptoms when stopping abruptly after prolonged or high-dose use, so dose reductions are often done gradually under medical guidance.