Stilnoct

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Stilnoct

Treatment option: Insomnia

Medically reviewed

Marina Burgos

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 Stilnoct

Property Description
Active ingredient Zolpidem tartrate
Form Film-coated tablets (Oral formulation)
Pharmacological class Sedative-hypnotic (Z-drug)
Common use Aid for sleep initiation in adults
Origin Synthetic imidazopyridine derivative

Stilnoct: A Nonbenzodiazepine Z-Drug Identity

Stilnoct is a brand name for a prescription-only medicine with the active ingredient Zolpidem tartrate, and is commonly associated with its manufacturer, Sanofi. It is classified pharmacologically as a sedative-hypnotic drug and is a prominent member of the Z-drugs, which are chemically distinct from benzodiazepines.

The unique chemical structure of this synthetic compound—an imidazopyridine derivative—allows it to selectively target the GABAA receptor. This selective binding is clinically recognized as promoting sedation with fewer muscle relaxant effects compared to traditional benzodiazepines. This focused action relates to the drug's intended function as a specialized hypnotic agent.

Composition and Pharmaceutical Form

The medicine is supplied as film-coated tablets, a standard oral formulation presented as a single-ingredient product. These tablets contain the precise dose of Zolpidem tartrate alongside pharmaceutical excipients necessary for stability and absorption via the oral route of administration. Stilnoct's formulation includes both immediate-release and prolonged-release formats, differentiating its action profile.

Zolpidem functions to decrease the time required to fall asleep, which is its primary role in addressing sleep latency. This characteristic aligns with the drug's primary therapeutic focus.

General Purpose of Stilnoct

The general purpose of Stilnoct is to function as a short-acting hypnotic designed to rapidly facilitate the transition to a sleeping state. It is primarily used to address transient or short-term difficulty initiating sleep in adults. This application focuses the drug's sedative action on the necessary neurological transition, which is the singular, overarching benefit sought in this therapeutic area.

Regulatory References

  1. Stilnoct 10mg Film-Coated Tablets SPC - Medicines.ie

What side effects are possible with Stilnoct?

Possible Side Effects and Safety Information

Stilnoct (Zolpidem tartrate) has a safety profile classified according to incidence rates observed in regulatory documents, with adverse reactions grouped by System-Organ-Class (SOC).

Frequency-Classified Adverse Reactions

The most frequently reported effects, categorized as Common (ge 1% to < 10% of users), include drowsiness, dizziness, headache, fatigue, and gastrointestinal effects like nausea and diarrhoea. Other common effects include psychiatric disturbances such as hallucinations and agitation. Less common effects, or Uncommon (ge 0.1% to < 1%), may involve confusion, ataxia (lack of coordination), and skin reactions like rash.

Serious Adverse Reactions and Safety Constraints

The official safety profile includes warnings for rare but serious adverse reactions. These include complex sleep-related behaviors, such as sleep-driving or preparing food while not fully awake, which may lead to serious injury. Severe hypersensitivity reactions like angioedema (swelling of the face, tongue, or throat) are also documented.

The medicine is contraindicated in conditions such as severe hepatic insufficiency and acute or severe respiratory insufficiency.

Exposure- and Population-Specific Safety Patterns

The risk of adverse reactions is often higher at the start of treatment or during dose changes. The potential for dependence and tolerance is explicitly linked to the duration of use. Furthermore, the label notes specific risks for older adults, who have an increased vulnerability to effects like dizziness and falls.

Overdose and Emergency Response

Overdose with Stilnoct (zolpidem tartrate) is clinically documented as a progression of exaggerated central nervous system (CNS) depression. Official regulatory labeling indicates that clinical manifestations typically range from severe drowsiness (somnolence) to varying degrees of impaired consciousness, potentially advancing to a state of coma.

The most severe, officially documented outcomes include cardiovascular and respiratory compromise, with the potential for fatal consequences. This severe risk is explicitly highlighted in cases where zolpidem is taken in combination with other CNS depressant agents, including alcohol.

Immediate emergency help must be sought at once if an overdose of Stilnoct is suspected. Management is based on general supportive care and treating symptoms. Officially described procedures may include immediate gastric lavage and the administration of intravenous fluids as appropriate. Continuous monitoring of the patient’s overall condition is a required part of the official management protocol.

Regulatory information notes that the sedative-hypnotic effects of zolpidem can be reduced by flumazenil, a specific antagonist, although it must be used with caution due to potential neurological risks. For risk mitigation, official labeling advises prescribing the least amount feasible to avoid intentional overdose, particularly in vulnerable patient populations.

Therapeutic Uses of Stilnoct

This medication is applied across domains where additional symptomatic support is needed for sleep problems. It is used to help manage symptoms related to heightened physiological activity that manifest as difficulty initiating sleep and sleep maintenance issues (such as frequent or sustained nocturnal awakenings). It is commonly used across conditions presenting with acute episodes of sleeplessness. This use is generally limited to areas where short-term symptom management is appropriate.

The use is relevant for managing the associated symptoms that interfere with daily functioning, such as those linked to daytime tiredness or decreased focus. A primary intended benefit is the support provided to help achieve a sense of restfulness, which contributes to easing the overall symptom load.

“It is primarily applied in scenarios where short-term symptomatic assistance is appropriate for sleep difficulties.”

This support may assist with maintaining functional stability and helps improve day-to-day comfort during symptomatic periods, particularly when symptoms become more noticeable.


Quick Fact: Relief for Symptoms Associated with Sleep Disruption

This medication may assist with managing symptom clusters that may become intense or disruptive, such as difficulty falling asleep and difficulty staying asleep.

Eligibility and Restrictions for Use

Stilnoct (zolpidem) is officially indicated for use in adults who have difficulty falling asleep.

Populations Who Must Not Use Stilnoct (Contraindications)

Official regulatory documents strictly prohibit the use of Stilnoct in patients with:

  • Known hypersensitivity to zolpidem or any tablet component.
  • Severe hepatic insufficiency (severe liver failure), which may increase the risk of encephalopathy.
  • Acute and/or severe respiratory insufficiency or sleep apnea syndrome.
  • Myasthenia gravis (a neuromuscular disease).
  • A history of experiencing complex sleep behaviors (e.g., sleepwalking, sleep-driving) after taking zolpidem or similar medicines.

Restricted or Not Recommended Populations

Population Eligibility Status (Regulatory Basis)
Children and Adolescents (under 18) Use Not Established (Safety and effectiveness have not been proven in this age group).
Older Adults (Elderly) Use requires special caution; a lower initial dose is recommended due to increased sensitivity and risk of falls.
Pregnant Women Not recommended for use.
Lactating/Breastfeeding Mothers Not recommended unless clearly necessary.
Mild to Moderate Hepatic Impairment Requires dose adjustment and caution; clearance is reduced.
History of Substance/Alcohol Abuse Requires extreme caution and careful surveillance due to increased risk of dependence.

Use of Stilnoct is restricted to short-term treatment and must be discontinued immediately if any complex sleep behavior is observed.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official government regulatory documents classify the interaction profile of Stilnoct (Zolpidem tartrate) into two primary categories: pharmacodynamic additive effects and pharmacokinetic alterations.

1. Pharmacodynamic Interactions

Co-administration with other Central Nervous System (CNS) depressants can cause officially documented additive psychomotor impairment and increased drowsiness. This includes substances such as opioids, which heighten the risk of respiratory depression, and alcohol, which is explicitly noted to increase adverse psychomotor effects. The product label documents decreased alertness when zolpidem is co-administered with medicines like Imipramine and Chlorpromazine.

2. Pharmacokinetic Interactions (Metabolic)

Zolpidem is primarily metabolized by the CYP3A4 enzyme. Interactions with substances that alter this enzyme system are officially documented:

Interacting Substance Interaction Type Outcome on Zolpidem Plasma Levels
Rifampin Strong CYP3A4 Inducer Documented decrease in exposure (may reduce efficacy)
Ketoconazole Strong CYP3A4 Inhibitor Documented increase in exposure (may increase effects)

Regulatory information states that co-administration with Sertraline also results in an officially documented increase in zolpidem exposure. Ingestion with a meal may slow the effect of the medication, representing an administration-timing interaction affecting the onset of action.

Mechanism of Action

How Stilnoct Works: Mechanism of Action


Selective Enhancement of GABA A Receptor Inhibition

This mechanism centers on the drug's high-affinity binding to the Benzodiazepine ( BZ1) site on GABA A receptors that contain the alpha1 subunit. This targeted action functions as a positive allosteric modulator, amplifying the natural inhibitory effects of the neurotransmitter GABA primarily within the central nervous system (CNS) pathways linked to consciousness.


Molecular Cascade to Neuronal Hyperpolarization

The amplification of GABA signaling causes an increased frequency of opening of the integral chloride ion channel. The rapid influx of negatively charged Cl^- ions destabilizes the nerve cell's potential, causing immediate neuronal hyperpolarization which suppresses its firing rate.


Systemic Suppression of Arousal Circuits

The cellular hyperpolarization rapidly translates into a systemic effect: the dampening of neural transmission across the cortical and thalamic areas responsible for maintaining alertness. This physiological shift quickly suppresses the CNS arousal circuits, resulting in a state of sedation and contributing to the physiological process of sleep induction.


Mechanistic Specificity and Limits

The alpha1 subunit selectivity is a key mechanistic factor, as it largely restricts the drug's action away from the alpha2 and alpha3 subunits that primarily mediate muscle relaxation and anxiolysis, shaping the resulting pattern of physiological effects. However, this receptor system is subject to homeostatic adjustments, meaning that prolonged modulation can lead to adaptive cellular changes, potentially resulting in receptor desensitization.

Dosage and Administration Information

Stilnoct (zolpidem tartrate) is administered via the oral route, and standard administration involves a single intake immediately before retiring for the night. Proper administration requires ensuring a full sleep opportunity of at least seven to eight hours before the planned time of awakening. A condition of use is that the tablet is not taken with or immediately after a meal, as food intake can delay the drug’s intended rapid onset of action.

Dosing and Duration Parameters

Standard adult dosing for immediate-release tablets typically begins at 10 mg once nightly, with the maximum daily dose limited to 10 mg. A lower initial dose of 5 mg is utilized for women due to observed differences in drug clearance rates. The maximum dose for extended-release formulations is 12.5 mg.

Dose adjustments are specified for certain patient populations. Older adults (geriatric patients) and individuals with hepatic impairment are initiated on a reduced dose of 5 mg (IR) or 6.25 mg (ER) to accommodate reduced metabolism. Use is not recommended for the pediatric population (below 18 years).

Treatment is for short-term use only, ranging from a few days up to a maximum total duration of four weeks. Re-administering a dose during the same night is not recommended, and the overall course is designed to conclude with a period of gradual withdrawal to finalize therapy.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Stilnoct


Evidence for Use in Short-Term Insomnia Management

This section will summarize the evidence from key randomized controlled trials (RCTs) that helped define the medicine’s research scope in short-term difficulties with falling asleep and staying asleep. The main evidence comes from RCTs, which are often placebo-controlled to evaluate measured changes. In this research, the medicine was evaluated in cohorts of individuals presenting with acute or episodic manifestations of sleeplessness.

Researchers primarily monitored outcomes related to sleep initiation and maintenance. Studies reported measurements related to sleep latency that were distinct from those observed in the inactive treatment groups. Additionally, research highlighted patterns in measured outcomes, including those related to total sleep time and the frequency of nocturnal awakenings in the observed populations.


Study Design and Evaluation Against Comparators

The core research was evaluated in controlled settings where patients received either the medicine or a placebo (an identical-looking inactive capsule) without knowing which was administered. Research observed patterns in measured outcomes that were distinct between the groups receiving the medicine and those receiving the placebo.

Furthermore, research was studied for outcomes related to use against certain other sedative-hypnotic agents. Comparative studies against certain other agents described outcomes that were similar on some measured sleep endpoints.


Evidence in Specific Patient Populations and Research Uncertainty

Research was studied for use in cohorts of older adults (typically age 65 and above), where studies explored potential differences in how the body processes the medicine. Studies also monitored use in populations with pre-existing conditions that affect metabolism.

Controlled data concerning long-term outcomes are not fully established for the general population, as the majority of core evidence focuses on short-term symptom changes. The research describes patterns observed solely within the studied populations, and findings describe group patterns and do not predict individual responses.

Key Studies & References Zolpidem - StatPearls

Frequently Asked Questions (FAQ)

Common questions about Stilnoct (FAQ)


Q: How long does it typically take for Stilnoct to start working?

Regulatory documents describe Stilnoct as a short-acting hypnotic with a rapid onset of action designed to quickly facilitate the transition to sleep. The official administration conditions state that the medicine is to be taken immediately before retiring for the night. Taking the medicine with a meal may delay its intended rapid effect.


Q: Can Stilnoct cause changes in behavior?

Official product information indicates that zolpidem has been associated with changes in thinking and behavior. These reported events include restlessness, agitation, and complex sleep behaviors, such as sleep-driving or preparing food while not fully awake.


Q: What is the risk of daytime sleepiness with Stilnoct?

The product label includes warnings about the potential for next-day psychomotor impairment, which can manifest as impaired alertness and drowsiness. Regulatory documents state that this risk increases when less than a full sleep opportunity of seven to eight hours is obtained.


Q: Are there any food or drinks that should be avoided with Stilnoct?

Regulatory guidance advises against consuming alcohol due to an increased risk of adverse psychomotor effects. Official use conditions also note that taking the tablet with or immediately after a meal may delay the intended rapid hypnotic effect.


Q: Does Stilnoct affect driving ability?

Official safety information explicitly warns of the risk of next-day impairment, including impaired driving ability. This safety constraint is detailed in the product label, which indicates that impairment may occur regardless of the user's perceived alertness.


Q: Can taking Stilnoct lead to memory issues?

Official documents note the risk of anterograde amnesia, a type of short-term memory loss. The risk is noted to be associated with the use of the medicine, particularly when the recommended sleep duration is not available.


Q: How does the onset time of Stilnoct compare to other common hypnotics?

Clinical research has examined zolpidem alongside certain other sedative-hypnotic agents. Studies described outcomes that were similar on certain measured sleep endpoints when compared to these other agents.


Q: Is it safe to stop taking Stilnoct suddenly?

Official regulatory documents state that the overall course of therapy is to conclude with a period of gradual withdrawal. This is to avoid the potential for a withdrawal syndrome and a transient return of insomnia symptoms in an enhanced form (rebound insomnia).


Q: Do studies suggest any difference in effectiveness between males and females?

Official documents note that women may have higher concentrations of zolpidem in the blood due to observed differences in how the body clears the drug. This difference in clearance rates is the basis for regulatory documents specifying a lower initial dose for women.


Q: Does Stilnoct stay in your system for a long time?

The medicine is characterized by a relatively short elimination half-life. This pharmacokinetic characteristic indicates that the active ingredient is processed and cleared from the body's system relatively quickly.


Q: Does Stilnoct interact with common painkillers like paracetamol?

Official drug labels primarily detail interactions with Central Nervous System (CNS) depressants and specific metabolic enzyme alterers. Paracetamol (acetaminophen) is not typically listed in these specific interaction risk categories for zolpidem in regulatory documents.


Q: What happens if I accidentally take my Stilnoct during the day?

The medicine is officially indicated for night-time use only, with a requirement for a full night’s sleep opportunity. Taking it during the day may lead to effects such as psychomotor impairment, decreased alertness, and an increased risk of falls due to severe drowsiness.


Q: Can Stilnoct be crushed or split?

The official prescribing information for the extended-release form states that it should not be divided, crushed, or chewed. Administration of the immediate-release tablet must strictly follow the instructions provided in the product's official prescribing information.


Q: Can Stilnoct be used by people with kidney problems?

Studies have shown that the way zolpidem is processed is not significantly different in patients with compromised renal function (kidney problems). Regulatory documents generally consider that no dosage adjustment is necessary in this population.


Q: What are the signs of dependence on Stilnoct?

The risk of dependence is noted in official safety information. The presence of dependence may be indicated by the onset of a withdrawal syndrome upon abruptly stopping the medicine, with symptoms that can include headaches, extreme anxiety, restlessness, and muscle pain.


Q: Does Stilnoct cause any unusual dreams or nightmares?

Nightmares are listed as a possible adverse psychiatric reaction in the official product information associated with the use of zolpidem.


Q: What does official information say about Stilnoct and rebound insomnia?

Official information notes the possibility of rebound insomnia, a transient syndrome where the symptoms that led to treatment (insomnia) may return in an enhanced form upon withdrawal of the hypnotic agent.


Q: Does Stilnoct interact with herbal supplements?

Official labels note the importance of patients informing their healthcare provider about all concomitant use, including herbal products. This disclosure allows for an assessment of potential interactions, particularly those involving known enzyme systems.


Q: What if I forget to take my Stilnoct before bed?

Regulatory instructions specify that the medicine should only be taken when a full 7 to 8 hours of sleep opportunity is available before the planned time of awakening. The constraint is that the medicine is not to be taken if this full period cannot be achieved.

How should Stilnoct be stored and disposed of?

The storage and disposal of Stilnoct (zolpidem tartrate) tablets must adhere strictly to the conditions specified in official regulatory labeling to maintain stability and ensure security.

Official Storage Conditions

Item Requirement
Storage Temperature Store at controlled room temperature, 68^circ to 77 F (20^circ to 25 C). Do not store above 25 C.
Protection Keep in the original package to protect from light and moisture.
Child Safety Keep out of the sight and reach of children and store in a safe place to prevent misuse.

Official Disposal Instructions

Item Requirement
Pharmaceutical Waste Disposal of unused product must be conducted in accordance with applicable local and national regulations for pharmaceutical waste.
General Rule The label indicates no special requirements beyond general waste handling compliance; however, it is a controlled substance (Schedule IV), and national agencies recommend using drug take-back programs when available.

Regulatory requirements define how the product must be stored, mandating strict temperature control and packaging protection to support the established shelf life. Security requirements specify keeping the controlled substance out of reach of children and in a safe place. Disposal must comply with official waste handling laws.

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

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