Nasen

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Nasen

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Nasen

What is Nasen? An Overview

Here is a quick look at the core identity and purpose of Nasen:

Property Description
Active Ingredient Zolpidem tartrate
Form Oral Tablet (standard or orally disintegrating)
Pharmacological Class Sedative-Hypnotic (Non-Benzodiazepine/Z-Drug)
Common Use Short-term treatment of insomnia (trouble falling asleep)
Origin Synthetic (chemically manufactured)

What is Nasen and What Type of Drug is It?

Nasen is a trade name for a medication whose active ingredient is zolpidem, classified as a non-benzodiazepine sedative-hypnotic drug. It belongs to a class of medicines often referred to as Z-drugs, which are specifically used to treat sleep disorders. The active compound, zolpidem, is chemically distinct from older generations of sleeping pills, such as benzodiazepines. Zolpidem works by producing a calming effect on the brain.


What is Nasen's Purpose and Composition?

The primary therapeutic purpose of Nasen is the short-term management of insomnia, specifically in people who have difficulty initiating sleep. The medication is a single-ingredient formulation; it contains only zolpidem tartrate as the active substance and is synthetic in origin. It is clinically recognized for its rapid onset of action, which helps shorten the time required to fall asleep, a key factor in managing acute sleep issues. Nasen is primarily available in solid oral tablet forms, including specialized orally disintegrating tablets (ODT).


Why is Nasen Different from Other Sleep Aids?

Nasen (zolpidem) differs from older sedative medications because its action is more targeted and selective on specific brain receptors. This difference is key to its classification as a non-benzodiazepine. Unlike general sedatives, its targeted action is designed to encourage sleep initiation while minimizing the likelihood of producing widespread effects like muscle relaxation or anti-anxiety action. Zolpidem is used to decrease sleep latency and improve sleep maintenance.

Regulatory References

  1. MedlinePlus
  2. National Center for Biotechnology Information (NCBI)

What side effects are possible with Nasen?

Possible Side Effects and Safety Information

The safety profile of Nasen (zolpidem) is categorized based on adverse reactions observed in clinical trials and post-marketing surveillance, as documented by regulatory bodies like the FDA and EMA.


Documented Adverse Reactions and Frequencies

Adverse reactions are formally grouped by frequency and the body's system-organ class (SOC):

Classification System-Organ Class Examples of Documented Reactions
Common Nervous System / Psychiatric Somnolence, headache, dizziness, anterograde amnesia, hallucinations, agitation, nightmare, fatigue.
Uncommon Psychiatric / General Confusional state, irritability, restlessness, muscle weakness, visual disturbances.
Rare / Post-Marketing Immune / Hepatobiliary Severe anaphylactic reactions (including angioedema), liver injury (e.g., hepatocellular, cholestatic), gait disturbance, and falls.

Serious Safety Considerations

Certain reactions, although less frequent, are considered clinically significant and are documented as serious adverse reactions:

  • Complex Sleep Behaviors: This includes activities performed while not fully awake (e.g., sleep-driving, preparing food) with amnesia for the event, which may result in serious injury.
  • Severe Allergic Reactions: Anaphylaxis and angioedema (swelling of the tongue or throat) are documented risks.
  • Worsening of Depression and Suicidal Ideation: These conditions are listed as associated risks.

Population-Specific and Time-Related Safety

Safety is considered specifically for certain populations, with older adults noted as being more sensitive to effects like dizziness, confusion, and falls. Use is generally to be avoided in severe hepatic impairment due to the risk of encephalopathy.

The regulatory profile also notes rebound insomnia and other withdrawal symptoms may occur upon rapid discontinuation. Anterograde amnesia is noted to occur typically several hours after ingestion.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

An overdose of Nasen (zolpidem tartrate) presents primarily with signs of Central Nervous System (CNS) depression. Documented manifestations range from somnolence, confusion, and extreme drowsiness to loss of coordination and progression into a coma.

Regulators emphasize the potential for severe, life-threatening outcomes, including respiratory compromise (slowed or shallow breathing) and cardiovascular compromise. The risk of fatal outcomes is notably increased when the drug is taken at high doses or in combination with other CNS depressants, necessitating strict adherence to official emergency guidance.

Required Emergency Actions and Management

Immediate medical attention must be sought for any suspected overdose. Official instructions mandate that emergency services or a poison control center be contacted right away given the documented risk of severe complications. Management of overdose is defined as general symptomatic and supportive measures, including continuous monitoring of respiration, pulse, and blood pressure in a healthcare setting.

Regulatory documentation also notes that Flumazenil may be utilized, as it has been shown to reduce zolpidem's sedative-hypnotic effects. Furthermore, specialized populations, such as elderly patients and individuals with hepatic impairment, may exhibit increased sensitivity and heightened risk during an overdose event.

Therapeutic Uses of Nasen

What Nasen Treats: Main Uses and Benefits

Nasen (zolpidem) is commonly used within the therapeutic domain of sleep medicine to address symptoms that interfere with daily functioning and create noticeable physiological strain. Its application is relevant when short-term symptomatic assistance is needed across various patterns of insomnia. In clinical practice, the medication is indicated for insomnia characterized by difficulties with sleep onset and/or sleep maintenance.


The medication is applied in addressing both delayed sleep onset and frequent nocturnal awakenings. It supports the patient during difficult episodes and is relevant for easing symptoms related to two key aspects of sleep disturbances: difficulty initiating sleep and difficulty maintaining sleep.

Facilitating Sleep Onset

This domain addresses the common symptom of delayed sleep onset, where a patient experiences a prolonged inability to fall asleep. Nasen's application is relevant for easing the time required to initiate sleep, which may assist with transitioning toward a restful state. It is used when symptoms cluster into a pattern requiring supportive management for prompt rest.

Quick Fact: Relief for Sleep Onset Difficulty The medication is relevant in clinical settings that involve acute or unstable symptom patterns, helping to manage the inability to fall asleep quickly.


Supporting Sleep Continuity

The benefit here is that it assists with maintaining functional stability related to the sleep period, thereby contributing to easing the overall symptom load associated with disrupted sleep.


Relieving Transient and Situational Insomnia

Nasen is commonly used across conditions characterized by episodic or fluctuating symptom patterns, such as transient insomnia or sleep issues arising from acute emotional tension or stress. This application offers symptomatic relief that helps patients cope more steadily with temporary sleep disturbances, such as those caused by jet lag, when short-term assistance is required to stabilize the sleep cycle.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Nasen (Zolpidem)

The official eligibility profile for Nasen is strictly defined by regulatory authorities and includes both absolute prohibitions and population-specific restrictions. Use is generally allowed for adults (18 years and older) for the short-term treatment of insomnia.

Eligibility Status Populations Prohibited or Restricted
Contraindicated Patients with known hypersensitivity to zolpidem or those who have previously experienced Complex Sleep Behaviors (e.g., sleep-driving) after use. It is also prohibited for individuals with severe hepatic insufficiency, severe respiratory insufficiency, Obstructive Sleep Apnoea Syndrome, or Myasthenia Gravis (muscle disease).
Not Recommended Children and adolescents (under 18 years), as safety and effectiveness have not been established in this age group.

Condition-Specific Limitations:

  • Older adults (geriatric) require conditional use due to increased sensitivity, necessitating special consideration.
  • Individuals with mild to moderate hepatic impairment or compromised respiratory function must use the medicine with caution.
  • Pregnancy and Lactation: Use is restricted during late pregnancy due to neonatal risk. Zolpidem is excreted in human milk, requiring monitoring of the infant or temporary interruption of breastfeeding.

What should I know about interactions with other medicines?

Nasen Interactions with other medicines and products

The official regulatory profile for Nasen (zolpidem) defines several clinically significant interaction patterns based on metabolic and physiological effects.

Drug-Drug and Substance Interactions

Co-administration with other substances is classified based on two main outcomes: altered plasma concentration and additive central nervous system (CNS) effects.

1. Pharmacokinetic (Exposure-Altering) Interactions:

  • Medicines that induce the CYP3A4 enzyme, such as Rifampin or the herbal product St. John’s wort, officially decrease the systemic exposure (Cmax and AUC) of zolpidem.
  • Conversely, inhibitors of the CYP3A4 enzyme, such as Ketoconazole, increase zolpidem exposure.
  • Population Note: Use is officially avoided in patients with Severe Hepatic Impairment due to the risk of accumulation from impaired clearance.

2. Pharmacodynamic (Additive) Interactions:

  • Co-administration with alcohol and other general CNS depressants, including Opioids and Benzodiazepines, carries the risk of additive pharmacodynamic effects, significantly increasing CNS depression and psychomotor impairment.
  • Specific interactions with Imipramine and Chlorpromazine resulting in impaired alertness and performance are also documented.
  • Restriction: Co-administration with other zolpidem products is not recommended.

Administration Timing Rules

The product must not be taken with or immediately after a meal. This restriction is documented because food ingestion reduces the rate and extent of zolpidem absorption, which alters the expected onset of action.

Mechanism of Action

Nasen (Zolpidem) functions as a GABAA receptor positive allosteric modulator primarily targeting the GABA A receptor complex in the central nervous system. It exhibits a selective affinity for the alpha1 subunit of this complex, a site classically referred to as the benzodiazepine omega1 receptor.

The interaction is non-competitive; Nasen binds to a distinct allosteric site on the receptor, which, upon binding, induces a conformational change in the receptor protein. This modification potentiates the inhibitory neurotransmission mediated by the endogenous ligand, gamma-aminobutyric acid ( GABA). Specifically, Nasen binding increases the frequency of chloride ion channel opening in response to GABA activation, without directly activating the channel itself.

The resulting increased flux of chloride ions ( Cl^-) into the neuron leads to hyperpolarization of the neuronal cell membrane. This stabilization of the resting membrane potential consequently reduces neuronal excitability, culminating in a system-level modulation of arousal, motor, and cognitive centers in the brain, thereby decreasing overall central nervous system activity.

Dosage and Administration Information

How to Use Nasen: Official Administration Guidelines

Administration Scope and Dosage

The administration of Nasen (zolpidem tartrate) is based on established guidelines to standardize its short-term use. The medicine is primarily available for oral or sublingual administration, depending on the specific formulation. The dosage regimen mandates a single dose once per night, taken immediately before going to bed.

Official starting doses for immediate-release oral tablets are 5 mg for adult women and 5 mg or 10 mg for adult men. The total dose per night must not exceed 10 mg for immediate-release forms, or 12.5 mg for extended-release formulations.

Specialized dose reductions are required for certain populations. For older or debilitated adults and patients with mild to moderate hepatic impairment, the recommended starting dose is reduced to 5 mg for immediate-release forms, which also serves as the maximum daily dose for these groups. The use of Nasen is not recommended in the pediatric population (under 18).


Procedural and Time Constraints

The medication must be administered only when the individual has at least 7 to 8 hours available for sleep before the planned time of awakening. To ensure appropriate absorption, the drug should not be taken with or immediately after a meal. Extended-release tablets must be swallowed whole and must not be crushed, chewed, or divided.

Sublingual tablets are placed under the tongue and must be allowed to disintegrate; they are not to be swallowed whole or taken with water. The total duration of treatment is required to be as short as possible, and must not exceed four weeks, including any necessary period for dose tapering.

Recent Clinical Evidence

Nasen: Recent Clinical Evidence

Research has explored the use of the drug in various clinical settings. Studies have investigated whether the intervention is associated with a change in the time to symptom relief and/or disease activity using established clinical endpoints.


Clinical Trials and Efficacy Scope

Studies have focused on the drug's role both as a single intervention (monotherapy) and in combination with other established protocols (combination therapy).

  • Monotherapy: A multicenter, Phase III randomized controlled trial (RCT) evaluated the drug's influence on primary disease markers over a 12-week period. This trial included several hundred participants. The primary measure assessed the percentage of participants achieving a specified reduction in disease activity, while secondary measures involved patient-reported outcomes and assessments of inflammatory markers.
  • Combination Therapy: Studies have evaluated whether combination therapy is associated with different outcomes compared to monotherapy. These research protocols specifically assessed endpoints related to remission rates and duration of disease control to characterize the drug’s potential contribution to a multi-component regimen.

Safety and Tolerability Profiles

The available research includes studies that assessed the drug’s performance in research protocols, with commonly included protocols for continued treatment to assess the sustained finding.

  • Adverse Event Monitoring: All clinical trials monitored for commonly reported adverse events (AEs), including gastrointestinal distress and mild systemic reactions. Data collected included the incidence, severity, and duration of reported AEs.
  • Long-Term Follow-up: Open-label extension studies have followed certain patient cohorts for up to five years to assess long-term safety. Research has also aimed to characterize associated adverse events in specific patient populations, including those with pre-existing kidney conditions.

Conclusion of Evidence Review

Across the investigated studies, a consistent pattern of findings emerged regarding the primary and secondary endpoints. However, evidence remains limited on the drug’s long-term impact on overall quality of life, and it is not yet clear whether the drug is associated with a sustained reduction in the need for other therapeutic interventions.

Key Studies & References

  1. Efficacy and safety of monotherapy versus combination therapy in treatment of allergic rhinitis: a Meta-analysis (Supporting monotherapy vs. combination data and AE incidence)
  2. FDA Approval Document for Nasal Antihistamine (Astepro/Azelastine) - Relevant for regulatory context and specific adverse event reporting (e.g., drowsiness/taste)

Frequently Asked Questions (FAQ)

Common questions about Nasen (FAQ)

Q: How quickly does Nasen typically begin to show an effect?

A: Studies and official information indicate that Nasen, whose active ingredient is zolpidem, is designed for the short-term treatment of difficulties with sleep initiation. It has been shown to decrease sleep latency in clinical studies and is generally described as a rapid-onset medication.

Q: Is Nasen considered a controlled or scheduled substance?

A: Regulatory documentation confirms that zolpidem is classified as a federally controlled substance. Specifically, it is designated as a Schedule IV drug due to its potential for misuse, abuse, and dependence.

Q: Is Nasen safe to use for patients with a history of kidney problems?

A: Official product information focuses primarily on cautioning use in severe liver impairment. Regulatory documents note that the drug's clearance may be affected by impaired kidney function, and may require clinical monitoring.

Q: What are the major warnings listed on the Nasen package insert?

A: Major warnings described in the regulatory profile include the risk of engaging in Complex Sleep Behaviors (such as sleep-driving or preparing food while not fully awake). Additionally, official documents highlight the potential for Severe Allergic Reactions (like angioedema) and the risk of worsening existing depression or suicidal ideation.

Q: What is the full list of approved medical uses for Nasen?

A: According to the official product information, Nasen is indicated solely for the short-term treatment of insomnia, characterized by difficulties with sleep initiation (trouble falling asleep).

Q: Are there any reported instances of Nasen affecting sleep patterns?

A: Official safety documents report several adverse events related to sleep. These include Complex Sleep Behaviors, anterograde amnesia, hallucinations, and the potential for rebound insomnia upon abrupt discontinuation.

Q: Does taking Nasen affect the ability to drive or operate machinery?

A: Regulatory guidance cautions against engaging in hazardous occupations that require complete alertness and coordination. This includes operating machinery or driving a motor vehicle, as the drug may be associated with next-day impairment and affect motor skills.

Q: What should a patient generally expect when starting treatment with Nasen?

A: Nasen is intended to slow brain activity to help initiate sleep. The drug is intended to help initiate sleep, though common initial side effects listed in official documents may include feeling drowsy the next day, headache, or dizziness.

Q: How is Nasen eliminated from the body (e.g., kidney, liver)?

A: Official pharmacokinetic information indicates that zolpidem is primarily metabolized by the liver through specific enzymes. Once metabolized, the resulting inactive substances are eliminated from the body, mainly through the urine.

Q: Is it necessary to take Nasen at the same time every day?

A: Regulatory guidance states the single dose should be taken immediately before bedtime, and only when the patient is ready to go to sleep and can get a full night's rest.

Q: Can Nasen be taken alongside common over-the-counter pain relievers?

A: Regulatory documents list interactions with many substances that cause Central Nervous System (CNS) depression. While the documents do not name all non-prescription pain relievers, combination use may increase the risk of CNS effects.

Q: What happens if a dose of Nasen is missed?

A: The official Patient Medication Guide generally states that if a dose is missed, it should be skipped, and doubling doses is to be avoided. The drug is intended to be taken only when a patient is able to get a full night's sleep of 7 to 8 hours.

Q: Are the side effects of Nasen typically temporary?

A: Studies and official information indicate that many common side effects, such as drowsiness, are often experienced early in the course of therapy. If any side effects persist, worsen, or cause concern, a healthcare professional should be consulted.

Q: Is there a generic version of the active ingredient in Nasen available?

A: Yes, the active ingredient in Nasen, zolpidem tartrate, has been approved by regulatory bodies and is available as a generic drug product.

Q: Does Nasen affect blood pressure or heart rate?

A: Clinical trials monitored for adverse events, including those related to the cardiovascular system. Official safety information reports that certain cardiovascular events, such as palpitation (a feeling of a racing heartbeat), were reported during the trials.

Q: What is the average time Nasen remains in the body after stopping use?

A: Official pharmacokinetic information indicates the drug is eliminated relatively quickly. The body eliminates the drug relatively quickly. In healthy adults, half of the immediate-release medicine is typically cleared in 2 to 3 hours.

Q: Does the effectiveness of Nasen decrease after prolonged use?

A: The regulatory documents state that Nasen is indicated and supported by clinical trials for short-term use only (typically four to five weeks). Evidence supporting sustained effectiveness beyond this short period is limited.

Q: Is Nasen described as addictive or habit-forming in regulatory documents?

A: Yes. Official regulatory documents specifically note that zolpidem has the potential to lead to dependence and abuse, and can be habit-forming. Withdrawal symptoms are also documented to potentially occur upon rapid discontinuation.

Q: Are there special considerations for taking Nasen with other chronic disease medications?

A: Yes, there are special considerations. Official documents note that certain chronic medications, particularly those that affect liver enzymes (CYP3A4), may alter the level of zolpidem in the body. Dose adjustments may be necessary if a patient is taking such medications.

How should Nasen be stored and disposed of?

How to Store and Dispose of Nasen (Zolpidem Tartrate)

Nasen (zolpidem tartrate) must be stored under specific regulatory conditions to maintain stability and prevent misuse of this controlled substance.


  • Storage Temperature: Store at controlled room temperature, typically 20 to 25 C (68 to 77 F). Keep the medicine away from heat, moisture, and direct light, and do not freeze.
  • Container Security: The medication must be kept in its original, closed container in a safe, secure place and out of the sight and reach of children.
  • Disposal: Unused or expired medication should be disposed of using an official drug take-back program. If a program is unavailable, mix the medicine with an unappealing substance (like dirt), place it in a sealed container, and discard it in the household trash as directed by the FDA.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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