Staurodorm

Quick links to important sections

Staurodorm

Method of action: Anxiolytic, Hypnotic, Psycholeptics

Treatment option: Insomnia

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 Staurodorm

Quick Facts

Property Description
Active Ingredient Flurazepam Hydrochloride
Form Hard gelatin capsule
Pharmacological Class Benzodiazepine / CNS Depressant
Common Use Temporary relief of sleep disturbances
Origin Synthetic

Staurodorm is a prescription-only pharmaceutical product classified as a sedative-hypnotic agent, intended for the temporary relief of various sleep disturbances. This medicine is defined by its active component, Flurazepam Hydrochloride, and its fundamental function as a Central Nervous System (CNS) Depressant. Its purpose is to modulate brain activity to facilitate and maintain sleep. It is clinically recognized for its efficacy in assisting patients who experience difficulty falling asleep or maintaining sleep throughout the night.

What Type of Medicine is Staurodorm? (Classification and Identity)

Staurodorm belongs to the chemical and pharmacological class known as benzodiazepine derivatives. The active ingredient, Flurazepam, is a synthetic compound, manufactured as a chemical salt, and is classified as a single-ingredient product. The categorization as a benzodiazepine signifies that the medicine acts centrally within the brain to produce calming and sleep-inducing effects. The drug’s identity as a CNS Depressant establishes its fundamental effect of slowing down nerve excitability, a characteristic shared across the entire class.

Composition and Physical Form of Flurazepam Hydrochloride

The medication is composed of the active ingredient, Flurazepam Hydrochloride, which is typically formulated as a powder within a hard gelatin capsule. This capsule contains the active substance alongside inert excipients necessary for stability and proper oral delivery. The established oral route of administration is designed to deliver the compound consistently to the body. Flurazepam is distinct among many agents used for sleep because it produces active metabolites, such as N1-desalkyl-flurazepam, which contribute to its relatively long duration of effect. This long-acting property makes it a suitable choice for patients whose sleep disturbances include frequent nocturnal awakenings or premature early morning waking, differentiating its profile from shorter-acting alternatives.

General Purpose and Action of this Sedative-Hypnotic

The general purpose of this medicine is to provide temporary support for individuals experiencing various forms of sleep disturbance. It functions as a sedative-hypnotic by enhancing the action of the brain's natural inhibitory messenger, gamma-aminobutyric acid (GABA). This action of increasing the brain's natural calming signal helps to reduce the amount of time needed to fall asleep (sleep latency) and promotes an increase in the overall time spent asleep (total sleep time), thus addressing the core issues of insomnia.

Regulatory References

  1. Flurazepam Label (DailyMed - NIH)

What side effects are possible with Staurodorm?

The safety profile of Staurodorm (Flurazepam) is documented in official regulatory sources, with adverse reactions classified by frequency and affected organ system.

Adverse Reaction Classifications

Side effects frequently reported in the label are typically related to its function as a central nervous system (CNS) depressant. Common reactions include drowsiness, dizziness, lightheadedness, and impaired coordination (ataxia). These CNS effects may persist into the day after use, a pattern recognized by regulatory documents. Gastrointestinal disorders, such as nausea, vomiting, or stomach upset, are also commonly listed. Uncommon or Infrequent reactions include headache and unsteady gait.

Serious Safety Concerns

The official label mandates attention to specific severe adverse reactions. These include reports of Complex Sleep Behaviors, such as sleep-driving or other activities performed while not fully awake, with subsequent amnesia for the event. Rare but severe hypersensitivity reactions like anaphylaxis and angioedema (swelling of the tongue or throat) are also documented. Additionally, the risk of Anterograde Amnesia, which is impaired memory for new events following medication use, is noted.

Population and Duration Safety Notes

Safety notes for specific patient groups exist: Older adults are more susceptible to CNS effects like oversedation and coordination difficulties, which are associated with an increased risk of falls. Patients with hepatic impairment may experience greater accumulation of the drug and its active metabolites. Furthermore, long-term use is explicitly associated with the development of Tolerance (reduced effectiveness) and Physical/Psychological Dependence, and abrupt discontinuation may precipitate a temporary worsening of sleep difficulties (Rebound Insomnia). The regulatory safety information formally addresses these constraints and temporal patterns of risk.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Staurodorm (Flurazepam) overdose focuses on acute Central Nervous System (CNS) depression. Documented manifestations range from mild signs, including drowsiness, confusion, slurred speech, and impaired coordination (ataxia). Severe overdose can lead to life-threatening outcomes affecting the physiological systems, specifically respiratory depression, hypotension, circulatory depression, coma, and areflexia. The regulatory information emphasizes that the risk of these severe outcomes is significantly increased by the concomitant ingestion of alcohol or other CNS-depressant agents.


Mandated Emergency Action

Regulators explicitly state that patients must seek immediate medical attention or contact emergency services immediately upon any suspected overdose. Urgent medical care is required if symptoms escalate beyond mild lethargy to include difficulty breathing or profound unconsciousness. The official labeling notes that the elderly population and patients with hepatic impairment are at a heightened risk for severe outcomes.


Official Management Strategy

Management is primarily based on symptomatic and supportive treatment, including the maintenance of a patent airway and continuous monitoring of vital signs. While Flumazenil is documented as a specific antidote, its administration is subject to regulatory cautions regarding the potential for inducing seizures. Procedural steps such as gastric decontamination and the use of activated charcoal are described as potential supportive measures.

Therapeutic Uses of Staurodorm

What Staurodorm Treats: Main Uses and Benefits

The medication Staurodorm (Flurazepam) is generally used for the symptomatic relief of insomnia, a condition characterized by difficulty with falling asleep and staying asleep. This use is applied across domains where additional symptomatic support is needed. It is commonly used in clinical settings that involve acute or temporary sleep-disruptive episodes.

The therapeutic role of the medication helps in addressing key patterns of sleep disturbance, including sleep onset difficulty, frequent nocturnal awakenings, and premature early morning waking. The medication may be applicable for supportive relief in cases of episodic or transient insomnia.

“The use of this medication may assist patients during periods of heightened symptoms, contributing to improved comfort when functional stability becomes affected.”

This use is intended to offer supportive relief when short-term assistance is needed, and it may assist with managing the overall symptom burden, contributing to a sense of stability when sleep is disrupted.

Quick Fact: Relief for Insomnia Symptoms
Symptom focus Difficulty falling asleep, frequent waking, early waking
Use context Short-term symptomatic relief
Patient benefit Contributes to the management of overall sleep duration

Regulatory References

  1. DailyMed NIH official label

Eligibility and Restrictions for Use

The eligibility for Staurodorm (Flurazepam) is strictly governed by regulatory documentation, which outlines absolute prohibitions and mandated restrictions based on patient characteristics and pre-existing conditions.

Eligibility Scope

Classification Population/Condition Regulatory Status
Allowed Adult Patients (General indicated population) Permitted
Contraindicated Pregnant Women Absolute Prohibition
Contraindicated Severe Hepatic Insufficiency Absolute Prohibition
Contraindicated Myasthenia Gravis, Sleep Apnea Syndrome Absolute Prohibition
Contraindicated Hypersensitivity to flurazepam or other benzodiazepines Absolute Prohibition
Restricted Use Geriatric or Debilitated Patients Dosage must be limited
Restricted Use Renal or Mild-to-Moderate Hepatic Impairment Reduced dosage required
Not Recommended Persons under 15 years of age Safety/Effectiveness Not Established
Not Recommended Lactating/Breastfeeding Women Excreted in breast milk

Connection to the Overall Eligibility Profile

Official regulatory documents define who can and cannot use the medicine primarily by listing absolute contraindications based on specific comorbidities and physiological states. Use in older adults and patients with impaired organ function is conditionally allowed, but requires strict adherence to labeled precautions and mandatory dosage limitations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Staurodorm (Flurazepam) defines interaction patterns that primarily involve pharmacodynamic risks from central nervous system (CNS) depressants and pharmacokinetic risks from altered metabolism.


Documented Interaction Patterns

Interaction Type Interacting Substances/Categories Effect on Flurazepam/Interaction Outcome
Additive CNS Depression Opioids, Antipsychotics, Sedative/Hypnotics, Antidepressants, Muscle Relaxants Significantly increased risk of sedation, respiratory depression, and coma. Co-use with opioids carries a Boxed Warning and is reserved for use when alternatives are inadequate.
Reduced Clearance Cimetidine, Atazanavir, Disulfiram These agents inhibit hepatic enzymes, leading to increased plasma concentrations of Flurazepam's active components.
Increased Clearance Rifampicin, Belzutifan, Bosentan These agents induce hepatic enzymes, leading to decreased plasma concentrations and potentially reduced effect.

Use Restrictions and Special Considerations

Alcohol co-intake is not recommended due to the unpredictable and adverse enhancement of the sedative effect, which impairs function. Caution is advised when co-administering with Clozapine, especially within a 24-hour window, due to the risk of severe outcomes. Interactions may be amplified in elderly patients and those with hepatic or renal impairment due to the reduced clearance of the long-acting active metabolite, necessitating greater attention to potential drug interactions.

Mechanism of Action

Staurodorm is a brand name for flurazepam, a benzodiazepine derivative. It is a highly lipophilic compound that readily crosses the blood-brain barrier, concentrating in the Central Nervous System (CNS).

Its primary biological target is the GABA-A receptor complex, specifically acting as a positive allosteric modulator at the benzodiazepine binding site, which is situated between the alpha and gamma subunits. The drug, or its active metabolite N-desalkylflurazepam, binds to this allosteric site and increases the frequency of chloride ( Cl^-) channel opening induced by the inhibitory neurotransmitter gamma-aminobutyric acid (GABA).

This enhanced Cl^- influx causes the hyperpolarization of the postsynaptic neuron membrane, which subsequently stabilizes the neuron in a less excitable state. The downstream cascade involves a reduction in overall neuronal excitability and decreased transmission of action potentials throughout the limbic system, thalamus, and hypothalamus. System-level physiological consequences are manifested as a generalized CNS depressant effect.

Dosage and Administration Information

How to Use Staurodorm: Official Administration Guidelines

Staurodorm, which contains the active ingredient Flurazepam Hydrochloride, is officially designated for oral administration as a hard gelatin capsule. The foundational principle guiding its use is to administer the lowest effective dose for the shortest possible duration.

Dosing and Schedule

The standard adult dose ranges from 15 mg to 30 mg, with the maximum recommended single dose being 30 mg. The medication is taken once daily (qHS), and administration must be timed to occur immediately before going to bed when the patient is ready to retire for the night.

Duration and Discontinuation

The use of Staurodorm is constrained to a short-term period, typically lasting only a few days to two weeks. The total treatment course, including any necessary dose adjustments, should not exceed four weeks. Official guidelines further specify that discontinuation of the medicine must be gradual (a process known as tapering) to conform with proper usage protocol.

Population-Specific Use

Explicit instructions exist for adjusting the dose in specific patient populations. For older or debilitated patients, the dose is typically limited to 15 mg. A dose reduction is also required for patients presenting with hepatic or renal impairment. It is important to note that a missed dose should not be compensated by taking a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase II Clinical Trials: Focus on Mobility and Motor Function

Research has explored whether the compound could affect key aspects of mobility and motor function. These early trials primarily focused on examining the compound's short-term observations and how the compound was received by a small group of participants.

  • Mobility Assessment: A multicenter, randomized trial evaluated whether the compound could affect the ability to walk among participants with a specific motor impairment.
  • Tremor Evaluation: A separate study examined effects on tremor severity. Within the observed cohort, studies reported findings suggesting a potential reduction in tremor severity over the observed period. The findings remain limited due to the small size of the initial study.
  • Hypothesized Mechanism: Research hypothesized that the compound may affect muscle activation, and this potential mechanism was explored as a part of the study's secondary endpoints.

Combination Therapy Investigations

A second wave of studies focused on evaluating the compound when used in conjunction with a standard-of-care medication. This approach was compared to older methods to determine if the combined approach resulted in different outcomes.

  • Symptom Management: Studies explored whether the combination could potentially affect anxiety and fatigue levels in participants. The studies noted that the results varied significantly between the different cohorts examined, indicating heterogeneity in the response.
  • Onset and Duration of Effects: Research evaluated the onset of observed effects. Studies exploring long-term use have been conducted. These investigations aimed to establish what effects might be reported across different timeframes.
  • Conclusion Summary: The study reported findings that were examined when evaluating certain neurological symptoms in the context of the combination treatment, but it did not provide a definitive basis for clinical application. Findings were mixed regarding sustained benefit beyond the treatment period, and further research is necessary to clarify outcomes.

Key Studies & References

  1. A Phase 2 RCT Study of CX-8998 for Essential Tremor (ClinicalTrials.gov ID NCT03101241)

Frequently Asked Questions (FAQ)

Common questions about Staurodorm (FAQ)


Q: How does Staurodorm actually work in the brain to help you sleep?

A: Staurodorm works by acting as a central nervous system (CNS) depressant. It enhances the action of a natural calming chemical in the brain, which slows down nerve activity. This overall calming effect is what helps to facilitate sleep and maintain it throughout the night.


Q: Is Staurodorm available over-the-counter or is it prescription only?

A: Official information confirms that Staurodorm, which contains the active ingredient Flurazepam, is a prescription-only medication. It is not available for purchase without authorization from a healthcare provider.


Q: Can Staurodorm affect my blood pressure?

A: Regulatory information indicates that small changes in blood pressure, such as a temporary drop (hypotension), can occur as a possible side effect of this class of medication. Concerns about blood pressure should be discussed with a healthcare provider.


Q: Is it okay to take Staurodorm every night?

A: Staurodorm is intended for short-term treatment of sleep disturbances, typically lasting only a few days up to two weeks, and not exceeding a total of four weeks. Official guidelines recommend using it only for the shortest time necessary.


Q: Does Staurodorm affect the effectiveness of birth control pills?

A: There are no common regulatory warnings stating that Staurodorm directly reduces the effectiveness of birth control pills. However, official guidance suggests that women who could become pregnant are generally advised to use reliable birth control methods while taking this medication.


Q: Is Staurodorm a controlled substance?

A: Yes, Staurodorm (Flurazepam) is classified as a controlled substance by regulatory authorities. This classification is due to its potential for dependence or misuse, which requires careful prescribing and monitoring.


Q: What kind of person should avoid taking Staurodorm entirely?

A: Regulatory documents list specific situations where Staurodorm is contraindicated (prohibited). This includes individuals with a known allergy to Flurazepam or other benzodiazepines, those with severe breathing issues like sleep apnea, and pregnant women.


Q: Can Staurodorm cause stomach upset or nausea?

A: Yes, official adverse reaction reports list gastrointestinal symptoms, such as nausea or stomach upset, as commonly reported side effects. Persistent or severe symptoms should be reported to a healthcare professional.


Q: What's the typical duration of treatment with Staurodorm?

A: The official product information specifies that treatment should be limited to short courses, generally ranging from just a few days to two weeks. The total course of treatment should not exceed four weeks, including any time spent reducing the dose.


Q: Does Staurodorm help with stress-related sleep problems?

A: Staurodorm is officially indicated for insomnia, which is difficulty falling asleep or staying asleep. Because it is a general sleep aid, it can be used in temporary situations where stress or anxiety are contributing to sleep difficulties.


Q: Is there a generic version of Staurodorm available?

A: Yes, the active ingredient in Staurodorm, which is Flurazepam, is commonly available as a generic medication. The generic form contains the same active ingredient as the brand name product.


Q: Does Staurodorm show up on a standard drug test?

A: Since Staurodorm is a benzodiazepine, the drug or its active metabolites are typically detectable on standard drug screens designed to test for this class of medicine. Testing personnel should be informed about all medications being taken.


Q: Is Staurodorm safe to take if I am pregnant or breastfeeding?

A: Staurodorm is strictly contraindicated (prohibited) for use during pregnancy. It is also not recommended for use by women who are breastfeeding because the medication’s active components may pass into breast milk.


Q: How should Staurodorm be stored to keep it effective?

A: The medication should be stored at the temperature specified on the label, typically below 25 C or 30 C. It must be kept in its original packaging to protect it from light and moisture, and always kept strictly out of the sight and reach of children.


Q: Why do some users report feeling 'heavy' after taking Staurodorm?

A: This feeling is likely associated with the common side effects of the medication related to its central nervous system (CNS) depressant effect. This includes officially reported symptoms such as drowsiness, lightheadedness, and general impaired coordination.


Q: Does Staurodorm impact REM sleep cycles?

A: Benzodiazepines, the class of drugs Staurodorm belongs to, are known to alter the natural cycle of sleep. This can include changes to sleep architecture, such as shortening the time spent in both deep sleep and Rapid Eye Movement (REM) sleep.


Q: Are there specific warnings about Staurodorm for people with breathing issues?

A: Yes, official warnings prohibit the use of Staurodorm in individuals with severe breathing problems, particularly sleep apnea syndrome. Caution is generally advised for all patients who have other pre-existing respiratory or lung conditions.


Q: What if Staurodorm doesn't seem to be working for my sleep?

A: If a user finds that sleep problems do not improve within 7 to 10 days of starting Staurodorm, or if they worsen, guidance should be sought from a healthcare professional. Lack of effect may signal a need to evaluate the underlying cause of the sleep issue.


Q: Can Staurodorm worsen symptoms of depression?

A: Official labeling includes warnings that the medication may cause mental and behavioral changes. These can include a worsening of insomnia and, in rare cases, a worsening of symptoms of depression, including suicidal thinking.


Q: Is Staurodorm used in other countries under a different name?

A: Yes, the active ingredient, Flurazepam, is known and used in many countries. It is marketed under several brand names globally, with Dalmane and Dalmadorm being two common examples.


Q: Why is Staurodorm sometimes mentioned in discussions about travel fatigue?

A: Because Staurodorm is prescribed for temporary sleep disturbances, it may be used by some individuals to address difficulty sleeping caused by jet lag or travel-related schedule changes. However, this is not a specific official indication for the medicine.


Q: Does Staurodorm work by relaxing muscles?

A: Yes, as part of its action as a benzodiazepine and central nervous system depressant, Flurazepam is generally stated to possess a skeletal muscle relaxant effect.


Q: Does Staurodorm change the way you dream?

A: While the label does not directly address changes to dream content, the medication is associated with adverse events such as memory impairment for new events (amnesia) and complex sleep behaviors. Any unusual sleep experience should be discussed with a doctor.


Q: Why do some people say Staurodorm helps with restlessness?

A: Staurodorm works by decreasing overall nerve excitability in the central nervous system. This general calming and sedative effect can often help to alleviate restlessness that may be interfering with the ability to fall or remain asleep.


Q: Are there any serious side effects I should watch out for with Staurodorm?

A: Official safety documents highlight serious concerns, including complex sleep behaviors like sleep-driving with no memory of the event, impaired memory for new events (anterograde amnesia), and rare severe allergic reactions (hypersensitivity). Awareness of these potential risks is necessary.


Q: Is it safe to take Staurodorm if I occasionally drink alcohol?

A: Co-intake of Staurodorm and alcohol is officially not recommended. Alcohol can unpredictably and adversely enhance the sedative effects of the medication, which can lead to dangerously impaired function and coordination.


Q: Can Staurodorm affect my ability to drive or operate machinery?

A: Because Staurodorm commonly causes side effects like drowsiness and impaired coordination, it is important to exercise extreme caution. These effects can persist into the next day and severely affect the ability to safely drive a vehicle or operate machinery.


Q: Can Staurodorm be taken with herbal supplements like melatonin or valerian root?

A: The official label details interactions with prescription medicines but does not specifically cover herbal supplements like melatonin or valerian root. As these supplements also have CNS effects, combining them with Staurodorm may increase the risk of over-sedation.


Q: Is it normal to feel a little dizzy when first starting Staurodorm?

A: Yes, dizziness is listed as a common side effect of Staurodorm. Like many medications that affect the central nervous system, users may experience these effects, particularly when first starting the treatment.


Q: Are there any known drug interactions between Staurodorm and antidepressant medications?

A: Yes, regulatory documents indicate that co-administration with antidepressants can lead to an additive CNS depressant effect. This combination carries an increased risk of severe sedation and respiratory depression.

How should Staurodorm be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documents define precise conditions to ensure the quality and stability of Staurodorm until its expiration date.

Storage Conditions

Requirement Official Statement
Temperature Store below 25 C (or 30 C) as specified on the label.
Protection Keep the product in the original packaging to protect it from light and moisture.
Handling Do not freeze the medicine.
Child Safety Keep this medicine strictly out of the sight and reach of children.

Disposal Protocol

Unused or expired Staurodorm must not be disposed of via household trash or wastewater systems. The official requirement is to return the medicine to a pharmacy or use a governmental drug take-back program. Disposal must always adhere to local environmental and pharmaceutical waste regulations.

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

Available in countries:

Equivalent of Staurodorm found in:

A-Z Index: