Edluar: Uses, Dosage & Side Effects
A sublingual zolpidem tartrate tablet for the short-term treatment of insomnia characterized by difficulty with sleep initiation in adults
Edluar (zolpidem tartrate) is a prescription sublingual tablet indicated for the short-term treatment of insomnia characterized by difficulty with sleep initiation in adults. Edluar belongs to the nonbenzodiazepine class of sedative-hypnotic medications, commonly known as “Z-drugs.” The sublingual formulation is placed under the tongue at bedtime, where it dissolves rapidly and is absorbed through the oral mucosa, facilitating a fast onset of sleep. Edluar is available in 5 mg and 10 mg strengths and is classified as a Schedule IV controlled substance due to its potential for dependence. Treatment should be limited to the shortest duration possible, typically 2 to 4 weeks, and should be used in conjunction with good sleep hygiene practices and, where appropriate, cognitive behavioral therapy for insomnia (CBT-I).
Quick Facts: Edluar
Key Takeaways
- Edluar (zolpidem tartrate) is a sublingual tablet that dissolves under the tongue for rapid absorption, specifically designed to help adults who have difficulty falling asleep due to insomnia.
- Available in 5 mg and 10 mg strengths, with the recommended starting dose of 5 mg for all patients and a lower 5 mg dose specifically recommended for women and elderly patients due to differences in drug metabolism and increased sensitivity.
- Treatment should be short-term (typically 2–4 weeks) due to the risk of tolerance, dependence, and complex sleep behaviors such as sleepwalking and sleep-driving.
- Edluar must never be combined with alcohol, opioids, or other CNS depressants, as this can result in severe respiratory depression, excessive sedation, coma, or death.
- Patients should only take Edluar immediately before bedtime when they can dedicate 7–8 hours to sleep, as next-morning impairment can affect driving and other activities requiring full alertness.
What Is Edluar and What Is It Used For?
Edluar contains the active substance zolpidem tartrate, a nonbenzodiazepine hypnotic agent of the imidazopyridine chemical class. Despite not being a benzodiazepine in its chemical structure, zolpidem acts on the same receptor system in the brain—the gamma-aminobutyric acid type A (GABA-A) receptor complex. However, unlike traditional benzodiazepines (such as diazepam, lorazepam, or temazepam), which bind non-selectively to multiple subtypes of the GABA-A receptor, zolpidem preferentially binds to the alpha-1 subunit (also known as the omega-1 or BZ1 receptor). This selectivity is clinically significant because the alpha-1 subunit is primarily associated with sedation and sleep induction, while other subunits (alpha-2, alpha-3, alpha-5) mediate anxiolytic, myorelaxant, and anticonvulsant effects. As a result, at therapeutic doses, zolpidem provides effective sedation with relatively fewer anxiolytic and muscle-relaxant side effects compared to traditional benzodiazepines.
The sublingual formulation of Edluar represents an important advancement over conventional oral zolpidem tablets. When placed under the tongue, the tablet disintegrates rapidly and the active substance is absorbed directly through the highly vascularized oral mucosa into the systemic circulation. This sublingual route of administration bypasses first-pass hepatic metabolism to some degree, which can result in faster achievement of effective plasma concentrations compared to standard oral tablets that must be swallowed, pass through the gastrointestinal tract, and undergo hepatic metabolism before reaching systemic circulation. Clinical pharmacokinetic studies have demonstrated that Edluar sublingual tablets achieve peak plasma concentrations (Tmax) within approximately 0.5 to 1.5 hours, facilitating rapid sleep onset.
Edluar is indicated specifically for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Insomnia is one of the most prevalent sleep disorders worldwide, affecting an estimated 10–30% of the adult population at any given time, with approximately 6–10% meeting diagnostic criteria for insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the International Classification of Sleep Disorders (ICSD-3). Insomnia is characterized by difficulty falling asleep (sleep-onset insomnia), difficulty maintaining sleep (sleep-maintenance insomnia), or early morning awakening with inability to return to sleep, occurring despite adequate opportunity for sleep and resulting in daytime impairment. Edluar is specifically targeted at the sleep-onset component of insomnia.
The pharmacokinetics of zolpidem support its use as a short-acting hypnotic. After sublingual administration, zolpidem has an elimination half-life of approximately 2.5 to 3 hours in healthy adults, which is short enough to promote sleep onset and early sleep maintenance without causing excessive next-morning sedation in most patients at recommended doses. Zolpidem is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP3A4, with smaller contributions from CYP1A2 and other CYP enzymes. The inactive metabolites are excreted primarily through the kidneys. Importantly, zolpidem does not accumulate significantly with repeated nightly dosing, reducing the risk of progressive sedation over the course of treatment.
International guidelines from the American Academy of Sleep Medicine (AASM), the European Sleep Research Society (ESRS), and the British Association for Psychopharmacology (BAP) recognize zolpidem as an effective pharmacological option for the short-term management of insomnia. However, all major guidelines emphasize that pharmacotherapy should ideally be used in conjunction with non-pharmacological approaches, particularly cognitive behavioral therapy for insomnia (CBT-I), which is recommended as the first-line treatment for chronic insomnia disorder. CBT-I addresses the underlying behavioral and cognitive factors that perpetuate insomnia and has been shown to produce durable improvements in sleep quality without the risks associated with long-term medication use.
The sublingual route offers potential advantages for insomnia treatment: the medication is absorbed through the blood-vessel-rich tissue under the tongue, which can result in faster onset of action compared to swallowing a tablet. Additionally, the sublingual route partially bypasses first-pass liver metabolism, meaning a greater proportion of the active drug may reach the bloodstream. This is particularly relevant for patients who need rapid sleep onset and for whom even a small delay in medication effect can be clinically meaningful.
What Should You Know Before Taking Edluar?
Contraindications
Edluar is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Allergic reactions to zolpidem, though uncommon, can include anaphylaxis and angioedema (severe swelling of the face, lips, tongue, or throat) and can occur after the very first dose or after any subsequent dose. If you have experienced an allergic reaction to zolpidem in any formulation previously, you must not use Edluar.
A critical and absolute contraindication is a history of complex sleep behaviors associated with zolpidem use. Complex sleep behaviors include activities such as sleepwalking, sleep-driving (operating a motor vehicle while not fully awake), preparing and eating food, making telephone calls, having sexual intercourse, and performing other activities while not fully conscious. These behaviors have been reported with zolpidem and other sedative-hypnotic medications and can result in serious injury or death to the patient or others. In 2019, the U.S. FDA added a Boxed Warning (the most serious type of warning) to all zolpidem-containing products, stating that patients who have experienced a complex sleep behavior episode must permanently discontinue the medication and never use it again.
Warnings and Precautions
Zolpidem can cause complex sleep behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake. These events can occur after the first dose or any subsequent dose, with or without the concomitant use of alcohol or other CNS depressants. Discontinue Edluar immediately if you experience a complex sleep behavior episode and contact your healthcare provider. Serious injuries and fatalities have been reported.
Before starting Edluar, it is essential to discuss the following with your healthcare provider:
- History of substance abuse or addiction: Zolpidem has abuse potential and is classified as a Schedule IV controlled substance. Patients with a history of alcohol or drug abuse are at increased risk of developing dependence on zolpidem. Your doctor should carefully evaluate the benefit-risk ratio before prescribing Edluar if you have a history of substance use disorders.
- Depression and psychiatric conditions: Sedative-hypnotic medications, including zolpidem, should be used with caution in patients with depression, as worsening of depression and suicidal ideation have been reported in association with their use. Insomnia may also be a presenting symptom of depression, and your doctor should evaluate whether the insomnia requires separate treatment or whether it is a symptom of an underlying psychiatric condition. Intentional overdose is more common in depressed patients; prescribe the smallest quantity of Edluar feasible.
- Respiratory disease: Zolpidem can cause dose-dependent respiratory depression. Use with particular caution in patients with compromised respiratory function, including those with chronic obstructive pulmonary disease (COPD), sleep apnea syndrome, or other conditions that reduce respiratory drive. The combination of zolpidem with opioids or other respiratory depressants significantly increases the risk of fatal respiratory depression.
- Hepatic impairment: Zolpidem is extensively metabolized by the liver. In patients with hepatic insufficiency, the clearance of zolpidem is reduced, resulting in higher and more prolonged plasma concentrations. Patients with severe hepatic impairment should not use Edluar. Those with mild to moderate hepatic impairment require dose reduction and careful monitoring.
- Myasthenia gravis: Zolpidem should be used with caution in patients with myasthenia gravis due to its potential to cause muscle weakness through GABA-ergic mechanisms.
- Elderly patients: Older adults are more sensitive to the effects of sedative-hypnotic medications due to age-related changes in drug metabolism and increased receptor sensitivity. The recommended dose for elderly patients is 5 mg. Elderly patients are at increased risk of falls, hip fractures, and cognitive impairment with zolpidem use.
Pregnancy and Breastfeeding
Edluar should not be used during pregnancy, particularly during the third trimester, unless the potential benefit clearly outweighs the potential risk to the fetus. Zolpidem crosses the placental barrier. Use of sedative-hypnotic medications in the late third trimester of pregnancy may cause neonatal sedation, hypotonia (reduced muscle tone), respiratory depression, and hypothermia in the newborn. There have also been case reports of neonatal withdrawal symptoms when mothers used zolpidem during late pregnancy. If Edluar is prescribed to a woman of childbearing potential, she should be advised to contact her doctor about discontinuing the medication if she becomes pregnant or intends to become pregnant.
Zolpidem is excreted in human breast milk in small amounts. A nursing infant could be exposed to a small fraction of the maternal dose. Because of the potential for sedation and other adverse effects in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue Edluar, taking into account the importance of the medication to the mother. If Edluar is used during breastfeeding, the infant should be monitored for excessive sedation, feeding difficulties, and respiratory depression.
Driving and Operating Machinery
Zolpidem can impair alertness and psychomotor performance the morning after use, even when taken as prescribed. Blood levels of zolpidem sufficient to impair driving and other activities requiring full alertness can persist into the morning hours. Women and patients taking the 10 mg dose are at greatest risk. The FDA recommends that patients be cautioned about the potential for next-morning impairment. Do not drive or engage in hazardous activities until you feel fully awake and your healthcare provider has assessed your response to Edluar.
Studies have demonstrated that zolpidem can impair driving ability, cognitive function, and psychomotor performance for up to 8 hours after administration. Women are at particular risk because they metabolize zolpidem more slowly than men, resulting in higher blood levels the morning after a bedtime dose. This sex-based pharmacokinetic difference led the FDA to recommend a lower starting dose of 5 mg for women in 2013, one of the first examples of sex-specific dosing recommendations for a widely used medication. Patients should be warned not to drive, operate heavy machinery, or engage in activities requiring full alertness until they know how Edluar affects them.
How Does Edluar Interact with Other Drugs?
Unlike monoclonal antibodies that have minimal drug interaction potential, zolpidem is a small-molecule drug that is extensively metabolized by hepatic cytochrome P450 enzymes, primarily CYP3A4. This makes it susceptible to pharmacokinetic interactions with drugs that inhibit or induce these enzymes. Additionally, zolpidem has important pharmacodynamic interactions with other central nervous system depressants that can result in additive or synergistic sedative effects.
Understanding these interactions is crucial for safe prescribing and use of Edluar. The most clinically significant interactions are detailed in the table below:
| Drug / Drug Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| Alcohol (ethanol) | Pharmacodynamic – additive CNS depression | Severe – risk of respiratory depression, coma, death | Absolutely contraindicated |
| Opioids (morphine, oxycodone, fentanyl, codeine, tramadol) | Pharmacodynamic – additive CNS and respiratory depression | Severe – increased risk of fatal respiratory depression | Avoid combination; use lowest doses if unavoidable |
| Benzodiazepines (diazepam, lorazepam, alprazolam) | Pharmacodynamic – additive GABA-ergic sedation | Severe – excessive sedation, respiratory depression | Avoid combination |
| Ketoconazole, itraconazole (CYP3A4 inhibitors) | Pharmacokinetic – increased zolpidem plasma levels | Moderate – enhanced sedation and side effects | Consider dose reduction of Edluar |
| Rifampicin, carbamazepine (CYP3A4 inducers) | Pharmacokinetic – decreased zolpidem plasma levels | Moderate – reduced efficacy of Edluar | Monitor efficacy; do not exceed max dose |
| SSRIs (sertraline, fluoxetine) | Pharmacodynamic – additive CNS effects; some are CYP inhibitors | Moderate – increased sedation, hallucinations reported with sertraline | Use with caution; monitor for increased sedation |
| Sedating antihistamines (diphenhydramine, hydroxyzine) | Pharmacodynamic – additive sedation | Moderate – excessive drowsiness, next-morning impairment | Avoid combination at bedtime |
| Muscle relaxants (baclofen, cyclobenzaprine) | Pharmacodynamic – additive CNS depression | Moderate – increased sedation and fall risk | Use with caution; consider timing separation |
Major Interactions
The most dangerous interaction is between Edluar and alcohol. Even moderate amounts of alcohol consumed on the same day as a bedtime dose of zolpidem can result in profound CNS depression, impaired consciousness, respiratory depression, and potentially fatal outcomes. This interaction is not merely additive but can be synergistic, meaning the combined effect is greater than the sum of the individual effects. Patients must be explicitly warned to completely avoid alcohol on any day they plan to take Edluar.
The combination of zolpidem with opioid analgesics is of particular concern due to the current opioid crisis and the frequent co-prescription of these medications in clinical practice. Both drug classes depress the central nervous system and can suppress the respiratory drive. The FDA has issued multiple warnings about the risks of combining sedative-hypnotics with opioids, and healthcare providers should carefully assess whether the benefits of combined therapy outweigh the significant risks. If the combination cannot be avoided, the lowest effective doses of both medications should be used, and the patient should be monitored closely for signs of respiratory depression and excessive sedation.
Minor Interactions
Caffeine, a CYP1A2 substrate and mild CNS stimulant, does not have a clinically significant pharmacokinetic interaction with zolpidem, but its stimulant effects can counteract the sedative effects of Edluar. Patients should be advised to limit caffeine intake, particularly in the afternoon and evening, as part of comprehensive sleep hygiene measures.
Food can affect the absorption of zolpidem. Taking Edluar with or immediately after a heavy meal can delay the onset of action. The sublingual formulation should be taken on an empty stomach for optimal absorption and fastest onset of sleep. Patients should not eat immediately before or after placing the tablet under the tongue.
Always provide your doctor and pharmacist with a complete list of all medications you are taking, including over-the-counter medicines, herbal supplements (such as valerian root or kava), and dietary supplements. Even seemingly innocuous over-the-counter sleep aids containing diphenhydramine or doxylamine can have dangerous additive sedative effects when combined with Edluar.
What Is the Correct Dosage of Edluar?
Edluar should always be used exactly as prescribed by your healthcare provider. The sublingual tablet is placed directly under the tongue at bedtime and allowed to disintegrate completely. It should not be swallowed whole, chewed, or crushed. Do not take Edluar with water, as this can reduce the sublingual absorption and alter the pharmacokinetic profile. The medication should be taken immediately before going to bed, and only when you are able to stay in bed for a full 7 to 8 hours before you need to be active again.
Adults
| Patient Group | Starting Dose | Maximum Dose | Notes |
|---|---|---|---|
| Women (all ages) | 5 mg | 5 mg | Women metabolize zolpidem more slowly; higher blood levels the next morning |
| Men (18–64 years) | 5 mg | 10 mg | May increase to 10 mg if 5 mg is not effective; use lowest effective dose |
| Elderly (≥65 years) | 5 mg | 5 mg | Increased sensitivity; higher risk of falls and cognitive impairment |
| Hepatic impairment (mild–moderate) | 5 mg | 5 mg | Reduced clearance; monitor closely for excessive sedation |
| Debilitated patients | 5 mg | 5 mg | Increased susceptibility to sedative effects |
The sex-based dosing difference for zolpidem is one of the most well-known examples in modern pharmacology. In 2013, the FDA required manufacturers of all zolpidem-containing products to lower the recommended dose for women from 10 mg to 5 mg based on pharmacokinetic data showing that women clear zolpidem approximately 45% more slowly than men. This difference means that women who take a 10 mg dose may have blood levels the following morning that are sufficient to impair driving and other activities. The recommended dose for women is therefore 5 mg, and this should generally not be exceeded.
For men, the recommended starting dose is 5 mg. If the 5 mg dose is not adequate, the dose may be increased to 10 mg, which is the maximum recommended daily dose. The total daily dose of zolpidem from all formulations combined should never exceed 10 mg. Taking more than one dose per night is not recommended under any circumstances.
Children and Adolescents
Edluar is not approved for use in children or adolescents under 18 years of age. The safety and efficacy of zolpidem have not been established in pediatric patients. Clinical studies in children have not demonstrated a benefit of zolpidem over placebo for treating insomnia, and some studies have reported higher rates of adverse events including dizziness, headache, and hallucinations in pediatric patients. The AASM and other professional organizations do not recommend zolpidem or other Z-drugs for the treatment of insomnia in children.
Elderly Patients
Elderly patients (65 years and older) should receive a dose of 5 mg, which should not be exceeded. The elderly are more vulnerable to the effects of sedative-hypnotics for several reasons: reduced hepatic metabolism leads to higher and more prolonged drug exposure; increased receptor sensitivity means a greater pharmacological effect at any given plasma concentration; and age-related changes in balance and coordination increase the risk of falls and fractures. Large epidemiological studies have consistently shown an association between Z-drug use in the elderly and increased risk of hip fractures, falls, road traffic accidents, and cognitive impairment. The American Geriatrics Society Beers Criteria lists zolpidem and other Z-drugs as potentially inappropriate medications for older adults.
Missed Dose
Edluar is taken on an as-needed basis at bedtime, so there is no “missed dose” in the traditional sense. If you forget to take Edluar at bedtime, do not take it later during the night unless you can still stay in bed for at least 7 to 8 hours. Taking zolpidem with fewer hours remaining before your wake time significantly increases the risk of next-morning impairment and drowsiness that can affect driving and other activities. Never take a double dose to compensate for a missed dose.
Overdose
If you suspect a zolpidem overdose, seek emergency medical attention immediately by calling your local emergency number. Symptoms of overdose include profound sedation, respiratory depression, loss of consciousness, and coma. The risk is dramatically increased when zolpidem is combined with alcohol, opioids, or other CNS depressants. Flumazenil (a benzodiazepine receptor antagonist) can be used as a partial antidote but may not fully reverse respiratory depression.
Zolpidem overdose can range from mild excessive sedation to life-threatening respiratory depression and coma, depending on the amount ingested and whether other CNS depressants were co-ingested. Single-substance zolpidem overdoses have generally been associated with a favorable outcome when managed promptly with supportive care, but fatalities have been reported, particularly in combination with alcohol or opioids. Flumazenil, a benzodiazepine receptor antagonist, has partial efficacy in reversing zolpidem’s effects and may be administered in a clinical setting. However, flumazenil should be used with caution in patients who may have co-ingested benzodiazepines or who have a history of seizures, as it can precipitate withdrawal seizures.
How to Take Edluar Sublingual Tablet
Correct administration of the Edluar sublingual tablet is essential for optimal drug absorption and therapeutic effect:
- Timing: Take Edluar immediately before getting into bed. Do not take it earlier in the evening while still engaged in activities.
- Preparation: Open the blister pack with dry hands. Do not remove the tablet until you are ready to take it.
- Placement: Place the tablet directly under the tongue. Do not swallow, chew, or crush the tablet.
- Dissolution: Allow the tablet to disintegrate completely under the tongue. This typically takes 30 to 60 seconds. Do not eat or drink anything for a few minutes after placing the tablet.
- Do not take with water: Swallowing the tablet with water converts it to an oral route of administration and may reduce the speed of absorption.
- Empty stomach: For fastest onset of action, take Edluar when you have not just eaten a meal. A full stomach may delay the onset of sleep.
What Are the Side Effects of Edluar?
Like all medicines, Edluar can cause side effects, although not everyone who uses it will experience them. The side effect profile of zolpidem is generally well characterized from decades of clinical use, large-scale clinical trials, and post-marketing pharmacovigilance data. The side effects listed below are categorized by their frequency of occurrence based on data from clinical trials and post-marketing surveillance.
It is important to note that the incidence of many side effects is dose-dependent: higher doses (10 mg) are associated with a greater frequency and severity of adverse effects compared to the lower dose (5 mg). This is one of the key reasons why guidelines recommend using the lowest effective dose. Sex differences in zolpidem metabolism also mean that women may experience side effects more frequently than men at equivalent doses.
Very Common
May affect more than 1 in 10 people
- Drowsiness and somnolence (including next-morning drowsiness)
- Headache
- Dizziness
Common
May affect up to 1 in 10 people
- Diarrhea
- Fatigue and lethargy
- Drugged feeling
- Dry mouth
- Nausea
- Back pain
- Dizziness and unsteadiness (ataxia)
- Memory impairment (anterograde amnesia)
- Sinusitis and upper respiratory tract infection
Uncommon
May affect up to 1 in 100 people
- Confusion and disorientation
- Nightmares and vivid dreams
- Irritability and agitation
- Hallucinations (visual or auditory)
- Depression (worsening)
- Diplopia (double vision)
- Abdominal pain
- Muscle cramps
- Skin rash
Rare
May affect up to 1 in 1,000 people
- Complex sleep behaviors (sleepwalking, sleep-driving, sleep-eating)
- Anaphylaxis and severe allergic reactions (angioedema, dyspnea)
- Paradoxical reactions (restlessness, aggressiveness, psychosis)
- Hepatic enzyme elevations
- Severe respiratory depression (particularly with co-ingested CNS depressants)
Not Known
Frequency cannot be estimated from available data
- Dependence and withdrawal symptoms (rebound insomnia, anxiety, tremor, sweating)
- Tolerance (reduced effectiveness with continued use)
- Falls (particularly in elderly patients)
Anterograde amnesia (the inability to form new memories after taking the medication) is a well-recognized effect of zolpidem that typically occurs when the patient engages in activities after taking the medication instead of going to bed immediately. Patients may perform activities such as making telephone calls, eating, or interacting with others and have no memory of these events the next day. This amnestic effect is more pronounced at higher doses and when Edluar is taken with alcohol.
The risk of physical dependence increases with dose and duration of treatment. Abrupt discontinuation of zolpidem after prolonged regular use (more than a few weeks) can result in withdrawal symptoms, which may include rebound insomnia (insomnia that is temporarily worse than before treatment), anxiety, agitation, tremor, sweating, palpitations, and in severe cases, seizures and delirium. To minimize withdrawal risk, Edluar should be tapered gradually under medical supervision rather than stopped abruptly after prolonged use.
Paradoxical reactions, while uncommon, are important to recognize. Some patients may experience agitation, restlessness, aggressiveness, delusions, rages, psychosis, or other inappropriate behavior after taking zolpidem. These reactions are more common in elderly patients and those with underlying psychiatric conditions. If paradoxical reactions occur, Edluar should be discontinued immediately.
Contact your doctor or seek emergency care if you experience: difficulty breathing or swelling of the face, lips, tongue, or throat (signs of severe allergic reaction); episodes of sleepwalking, sleep-driving, or other activities while not fully awake; worsening depression or suicidal thoughts; hallucinations, confusion, or unusual behavior; or any symptom that concerns you. Report all side effects to your healthcare provider, even if they seem minor.
How Should You Store Edluar?
Proper storage of Edluar is important to maintain the quality and effectiveness of the medication. The sublingual tablet formulation requires protection from moisture and light to maintain its stability and disintegration properties. Follow these storage guidelines:
- Temperature: Store at controlled room temperature, 20–25°C (68–77°F). Brief temperature excursions to 15–30°C (59–86°F) are permitted during storage and transport, as outlined in USP Controlled Room Temperature guidelines.
- Protection from moisture: Keep the sublingual tablets in the original blister packaging until immediately before use. The blister pack provides moisture protection that is essential for maintaining the tablet’s rapid disintegration properties.
- Protection from light: Store in the original carton to protect from light exposure, which can degrade the active substance over time.
- Keep out of reach of children: Zolpidem is a potent sedative that can be extremely dangerous in children. Even a single tablet can cause serious adverse effects in a child. Store Edluar in a location that is inaccessible to children.
- Secure storage: As a Schedule IV controlled substance, Edluar has potential for misuse and diversion. Store it in a secure location, preferably locked, to prevent unauthorized access by others in the household or visitors.
- Expiration date: Do not use Edluar after the expiration date printed on the blister pack and carton. The expiration date refers to the last day of that month.
- Disposal: Do not flush unused Edluar tablets down the toilet or dispose of them in household waste. Use a drug take-back program or follow FDA guidance on safe disposal of medications. As a controlled substance, proper disposal helps prevent accidental exposure and misuse.
What Does Edluar Contain?
Understanding the composition of your medication is important, especially if you have known allergies or dietary restrictions. Below is a detailed breakdown of the ingredients in Edluar sublingual tablets.
Active Ingredient
The active substance is zolpidem tartrate, an imidazopyridine-class nonbenzodiazepine hypnotic. Each sublingual tablet contains either 5 mg or 10 mg of zolpidem tartrate. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. The tartrate salt form is used because it provides good chemical stability and suitable dissolution characteristics for sublingual administration.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Zolpidem tartrate | Active substance (sedative-hypnotic) | 5 mg or 10 mg per tablet |
| Mannitol | Filler / diluent / sweetener | Sugar alcohol; also aids rapid disintegration |
| Colloidal silicon dioxide | Glidant / flow agent | Improves powder flow during manufacturing |
| Crospovidone | Superdisintegrant | Enables rapid disintegration under the tongue |
| Grape flavoring | Flavoring agent | Improves taste during sublingual dissolution |
| Saccharin sodium | Sweetener | Non-caloric sweetener for palatability |
| Magnesium stearate | Lubricant | Prevents tablet from sticking to manufacturing equipment |
Appearance and Pack Sizes
Edluar 5 mg sublingual tablets are white to off-white, round tablets. Edluar 10 mg sublingual tablets are white to off-white, round tablets of a slightly larger size. Both strengths are supplied in individual blister packs to protect from moisture, with each blister containing one tablet. Edluar is typically available in packs of 10 or 30 sublingual tablets. Not all pack sizes may be marketed in every country.
Marketing Authorization and Manufacturer
Edluar was originally developed by Orexo AB (Uppsala, Sweden) using their proprietary sublingual drug delivery technology. The marketing authorization in the United States was granted to Meda Pharmaceuticals (now part of Mylan, which is a division of Viatris Inc.). Edluar was approved by the FDA in March 2009 as a sublingual formulation of zolpidem tartrate. The sublingual formulation was developed to provide an alternative route of administration for patients who prefer a tablet that dissolves under the tongue rather than a conventional swallowed tablet.
Frequently Asked Questions About Edluar
Edluar (zolpidem tartrate) is a prescription sublingual tablet used for the short-term treatment of insomnia in adults who have difficulty falling asleep. It belongs to the class of medications known as nonbenzodiazepine sedative-hypnotics (Z-drugs). The sublingual formulation dissolves under the tongue for rapid absorption, helping to reduce the time it takes to fall asleep. Edluar is intended for short-term use only, typically 2 to 4 weeks, and should be used as part of a comprehensive approach to managing insomnia that includes good sleep hygiene practices.
Edluar is a sublingual (under-the-tongue) formulation of zolpidem tartrate, while Ambien is a conventional oral tablet that is swallowed. Both contain the same active ingredient (zolpidem tartrate) at the same doses (5 mg and 10 mg). The key difference is the route of administration: Edluar is absorbed through the oral mucosa under the tongue, which can provide faster absorption compared to swallowing a tablet. Another product, Ambien CR, is an extended-release formulation designed for both sleep onset and sleep maintenance. Intermezzo is a lower-dose (1.75 mg or 3.5 mg) sublingual zolpidem product specifically designed for middle-of-the-night awakening.
Yes, zolpidem has the potential to cause physical and psychological dependence, which is why it is classified as a Schedule IV controlled substance. The risk of dependence increases with higher doses and longer duration of treatment. When used as prescribed (lowest effective dose for the shortest duration, typically 2–4 weeks), the risk of dependence is relatively low. However, patients with a history of substance abuse are at higher risk. Signs of dependence include needing higher doses to achieve the same effect (tolerance), difficulty sleeping without the medication, and experiencing withdrawal symptoms when the medication is stopped. Always follow your doctor’s instructions regarding dose and duration of treatment.
Women metabolize zolpidem more slowly than men due to differences in liver enzyme activity (specifically CYP3A4). This means that women who take the same dose as men will have higher blood levels of zolpidem the following morning, increasing the risk of next-morning impairment that can affect driving and other activities. Based on pharmacokinetic data, the FDA recommended in 2013 that the dose of zolpidem for women be lowered to 5 mg. This was one of the first sex-specific dosing recommendations for a widely prescribed medication. Men may use either 5 mg or 10 mg depending on individual response, but should always start with 5 mg.
If you or someone in your household observes that you engage in activities while not fully awake after taking Edluar (such as sleepwalking, sleep-driving, making phone calls, preparing food, or other activities with no memory of the event), you must stop taking Edluar immediately and contact your doctor. These are called complex sleep behaviors, and they carry a risk of serious injury or death to yourself or others. The FDA has added a Boxed Warning to all zolpidem products stating that patients who experience a complex sleep behavior episode must permanently discontinue the medication and never use zolpidem again in any form.
Edluar is recommended for short-term use only, typically 2 to 4 weeks. International guidelines from the AASM, ESRS, and other professional bodies consistently recommend limiting the duration of sedative-hypnotic treatment to avoid the development of tolerance and dependence. If your insomnia persists beyond 2–4 weeks, your doctor should re-evaluate the underlying cause of your sleep difficulties and consider non-pharmacological treatments such as cognitive behavioral therapy for insomnia (CBT-I), which is considered the first-line treatment for chronic insomnia. Long-term use of zolpidem should only occur under close medical supervision with regular reassessment.
References
- U.S. Food and Drug Administration (FDA). Edluar (zolpidem tartrate) sublingual tablets – Prescribing Information. Revised 2024.
- FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). January 2013, updated May 2013.
- FDA Drug Safety Communication: FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. April 2019.
- Sateia MJ, Buysse DJ, Krystal AD, et al. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(2):307–349. doi:10.5664/jcsm.6470.
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