Dalmate

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Dalmate

Method of action: Anxiolytic, Hypnotic, Psycholeptics

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 Dalmate

The medication known as Dalmate is a prescription-only medication formulated as a Central Nervous System (CNS) depressant, primarily designated for promoting sleep. Its identity is directly linked to its active ingredient, the International Nonproprietary Name (INN) substance Flurazepam Hydrochloride, which is chemically identified as a synthetic compound derived from the benzodiazepine structure.

Property Description
Active ingredient Flurazepam Hydrochloride
Form Capsule
Pharmacological class Benzodiazepine Sedative-Hypnotic
Common use Facilitating sleep onset and maintenance
Origin Synthetic compound

1. The Definitive Classification: What Type of Medicine is Dalmate?

Dalmate belongs to the Benzodiazepine Sedative-Hypnotic pharmacological class. This means the active ingredient, Flurazepam, is structurally related to other Benzodiazepines and exerts a calming influence on the nervous system. The compound is classified as a single-ingredient product, which is clinically recognized for its intermediate-to-long duration of action among hypnotics. As a synthetic compound, the chemical structure of Flurazepam was manufactured to achieve its specific effect within the central nervous system, differentiating it from naturally derived sleep aids.

2. Composition, Form, and Therapeutic Purpose

The medication Flurazepam is supplied in the Capsule form intended for oral administration. The Capsule contains the potent active ingredient Flurazepam Hydrochloride alongside supporting inert ingredients, such as fillers and binders necessary for the pharmaceutical preparation. The general therapeutic purpose of this medication is to assist individuals by promoting both the process of falling asleep (sleep induction) and the capacity to remain asleep. This is particularly relevant in scenarios where a patient faces chronic difficulty in sleep onset and subsequent nocturnal awakenings, a typical use scenario for this class of intermediate-acting drug.

What side effects are possible with Dalmate?

Possible Side Effects and Safety Information

The official safety profile for Dalmate (Flurazepam Hydrochloride) is characterized by effects primarily related to Central Nervous System (CNS) depression, as documented in regulatory labeling.

Adverse Reaction Categories and Frequency

Adverse effects are classified based on frequency, with effects related to impaired physical coordination and alertness being the most commonly cited. Reactions generally placed in the common category include drowsiness, dizziness, unsteadiness (staggering), and ataxia (loss of coordination). Less frequent effects that have been reported include gastrointestinal reactions such as nausea, vomiting, and constipation.

Serious Adverse Reactions

The label documents several serious and clinically significant safety concerns. This includes the risk of physical and psychological dependence and the potential for severe withdrawal symptoms upon abrupt cessation. Serious behavioral disturbances, such as complex sleep-related behaviors (performing activities while not fully awake) with subsequent amnesia, are also explicitly documented. Additionally, the risk of respiratory depression is noted, particularly when the medicine is used at high doses or alongside other CNS depressants.

Population-Specific Safety Considerations

Older adults are subject to specific safety considerations and are noted to have increased sensitivity to the CNS depressant effects, substantially raising the documented risk of dizziness, confusion, and falls. Regulatory restrictions define that this medicine is generally contraindicated in conditions such as severe respiratory insufficiency and for patients with known hypersensitivity to benzodiazepines.

Overdose and Emergency Response

Overdose Manifestations and Progression

The overdose profile for Dalmate (Flurazepam Hydrochloride) is defined by official regulatory bodies through the spectrum of acute Central Nervous System (CNS) depression. Initial manifestations typically include extreme somnolence, drowsiness, confusion, ataxia (impaired coordination), and generalized muscle hypotonia. These symptoms are dose-dependent, progressing from deep sedation toward severe toxicity.

Life-Threatening Outcomes and Required Action

Urgent medical assistance is mandated when an overdose is suspected, as severe manifestations include life-threatening respiratory depression and marked hypotension. In severe cases, the state may progress to coma. Regulatory guidance stipulates that individuals exposed to an overdose must seek immediate medical attention or contact emergency services without delay, regardless of the severity of initial symptoms.

Management and Monitoring

The management principles documented in official sources are strictly symptomatic and supportive treatment, focusing on securing a patent airway and continuous monitoring of vital signs. While the reversal agent Flumazenil is recognized, its use requires professional judgment due to specific risks. Regulatory information also notes that elderly patients and those with impaired hepatic or renal function face an increased risk of prolonged and heightened effects.

Therapeutic Uses of Dalmate

What Dalmate Treats: Main Uses and Benefits

The medication Dalmate (Flurazepam Hydrochloride) is applied in contexts where additional support for sleep symptom management is needed, primarily addressing the condition of insomnia. This includes domains where additional symptomatic support is needed for sleep disturbances and conditions where symptoms interfere with daily functioning, such as difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakening.


Dalmate is relevant for easing these symptoms, which are often characterized by episodic or recurring sleep patterns that lead to temporary functional strain. By assisting with sleep onset, Dalmate provides supportive relief when symptoms interfere with routine activities. It is commonly used when symptoms intensify and short-term symptomatic assistance is needed, which contributes to maintaining functional stability.

Quick Fact

Quick Fact: Relief for Sleep Maintenance Disturbance Dalmate is often applied in clinical settings that involve acute or unstable symptom patterns. It plays a role in managing symptoms of impaired sleep continuity. This supportive benefit is relevant for managing symptoms that interfere with daily comfort.

Regulatory References

  1. DailyMed Labeling published by the NIH

Eligibility and Restrictions for Use

Who Can and Cannot Use Dalmate?

The eligibility to use Dalmate (Flurazepam Hydrochloride), a prescription-only benzodiazepine, is defined by strict regulatory criteria to ensure patient safety. Use is restricted based on age, physiological status, and pre-existing medical conditions.

Populations Prohibited from Use (Contraindications)

Dalmate is absolutely contraindicated and must not be used by:

  • Pregnant Women and women of childbearing potential not using reliable contraception.
  • Patients with a known hypersensitivity to flurazepam or other benzodiazepines.
  • Patients diagnosed with Myasthenia Gravis or Sleep Apnea Syndrome.
  • Individuals with severe hepatic insufficiency (severe liver failure) or severe pulmonary insufficiency (severe lung function impairment).
  • Children (Use is contraindicated).

Conditional and Restricted Use

  • Age: The medicine is not recommended for persons under 15 years of age. Geriatric or debilitated patients must be treated with extreme caution and should receive the lowest effective dose.
  • Organ Function: Caution is required when prescribing to patients with impaired renal or hepatic function.
  • History: Extreme caution is necessary for patients with a documented history of drug or alcohol dependence or abuse.

What should I know about interactions with other medicines?

Dalmate Interactions with other medicines and products

This section outlines documented, clinically significant interactions for products within the same pharmacologic class as Dalmate (a benzodiazepine).


Interaction Scope

Classification Detail
Interacting Medicinal Product Categories Central Nervous System (CNS) Depressants, Opioids, Alcohol, CYP3A4 inhibitors, CYP2C9 inhibitors.
Specific Interacting Medicines Opioid Analgesics (e.g., morphine, hydrocodone), Alcohol, Antihistamines (sedating), Antidepressants, and certain Anticonvulsants.
Mechanistic Basis of Interactions Pharmacodynamic (PD) Interaction: Concurrent use with other CNS depressants results in an additive depressant effect. Pharmacokinetic (PK) Interaction: Metabolism may be inhibited by drugs that block CYP3A4 or CYP2C9 enzymes, potentially increasing plasma levels and adverse effects.
Interaction-Related Restrictions The combination with opioid-containing products is classified as a serious risk that requires careful monitoring. Concurrent use with alcohol is strongly discouraged due to significant CNS depression.

Interaction Classification and Context

Classification Detail
Interaction Severity Classification Serious / Highly Clinically Significant (with CNS Depressants/Opioids); Use With Caution (with CYP enzyme inhibitors).
Population-Specific Interaction Notes Caution is advised in geriatric patients due to increased sensitivity to CNS depression and a higher risk of falls, particularly with co-administered depressants.

Official Interaction Statements

  • Do not use with alcohol or other CNS depressants unless the benefit clearly outweighs the risk, and only under strict medical supervision.
  • The combination with opioids significantly increases the risk for profound sedation, respiratory depression, coma, and death.
  • Dose adjustments or alternative therapy should be considered when co-administering with potent CYP3A4 inhibitors, which may lead to dangerously increased concentrations of Dalmate.

Connection to the overall interaction profile (2–4 sentences):

The primary concern in the regulatory profile is the substantial, additive CNS-depressant effect when combined with alcohol, opioids, or other sedating medications. This is defined as a life-threatening risk due to respiratory compromise, requiring an explicit warning against co-administration. Secondary, but still significant, interactions involve metabolic competition with inhibitors of the CYP450 enzyme system, which can exacerbate the primary CNS-depressant effects.

Mechanism of Action

Amplifying GABA's Inhibitory Power at the Receptor

Dalmate functions as a Positive Allosteric Modulator of the GABA-A receptor complex, the primary inhibitory receptor in the Central Nervous System (CNS). It binds to an allosteric site on the receptor, increasing the affinity for and enhancing the effect of the endogenous neurotransmitter GABA. This molecular interaction causes the receptor's central chloride ion ( Cl^-) channel to open more frequently. The resulting increase in Cl^- influx causes the neuron to hyperpolarize (become less excitable), which is the essential first step leading to widespread CNS depression.


Dampening Excitability in Core Neural Systems

This enhanced inhibitory signaling primarily affects high-activity functional systems, including the Ascending Reticular Activating System (ARAS) and the limbic system. By suppressing neuronal excitability across these functional systems, the mechanism directly produces a decrease in arousal and influences the physiological state of anxiolysis and sedation.


Modulating Motor Pathways

The mechanism extends its inhibitory influence to neurons involved in skeletal muscle control located in the spinal cord and supraspinal structures. This widespread inhibition of motor-regulating pathways leads to the physiological consequence of reduced muscle tone and influences motor coordination.

Dosage and Administration Information

How Dalmate is Used: Official Administration Guidelines

Dalmate (Flurazepam Hydrochloride) is administered exclusively through the oral route, with the medication supplied in capsule form. The established usage protocol dictates that the medication is taken once daily, and administration must occur precisely at bedtime, immediately before the patient retires for the night. The capsule must be swallowed whole with fluid and should not be opened, crushed, or chewed, as explicitly stated in the administration instructions.

The standard adult dose falls within a range of 15 mg to 30 mg. However, the official prescribing information requires that dosing be adjusted based on population-specific parameters. Specifically, the initial dosage is restricted to 15 mg for older adults and debilitated patients, and similar dosage reductions are necessary for individuals with hepatic or renal impairment, while use in the pediatric population is not recommended.

Procedurally, if a scheduled dose is missed, it should be skipped, and the individual must not take a double dose to compensate. The duration of therapy is explicitly limited; treatment should be maintained for the shortest time possible, typically 7 to 10 days, and should not extend beyond four continuous weeks, including any necessary period of gradual dose reduction (tapering). This duration constraint establishes Dalmate as a short-term use medication only.

Recent Clinical Evidence

Clinical Efficacy

Clinical trials for Dalmate (generic name: Daratumumab, Daratumumab and Hyaluronidase-fihj) have primarily focused on its use in treating certain types of multiple myeloma and light chain (AL) amyloidosis. These studies, typically Phase 3 randomized, controlled trials, have been instrumental in establishing the drug's effectiveness, often in combination with other established therapies.

In studies involving newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant, the addition of Daratumumab to standard regimens significantly improved the rate of stringent complete response and progression-free survival (PFS) compared to the standard regimen alone. For patients ineligible for transplant, combination therapy including Daratumumab has also demonstrated a statistically significant improvement in PFS.

For newly diagnosed light chain (AL) amyloidosis, clinical evidence supports the combination of Daratumumab and Hyaluronidase-fihj with standard treatment regimens. Key findings from a Phase 3 trial indicated a substantial improvement in Major Organ Deterioration Progression-Free Survival (MOD-PFS) and overall survival compared to standard treatment alone. These positive results led to its traditional approval by regulatory bodies.


Safety and Tolerability

The most common adverse events reported across the various trials for Daratumumab combination therapies often include infusion reactions, fatigue, and gastrointestinal issues such as nausea and diarrhea. Hematologic events, including neutropenia and thrombocytopenia, have also been frequently observed.

For the combination treatment used in AL amyloidosis, a warning regarding the potential for serious or fatal cardiac adverse reactions has been highlighted, emphasizing the need for caution in patients with advanced cardiac disease. Furthermore, the risk of hypersensitivity and other systemic administration-related reactions is noted, although most reactions tend to be mild or moderate and occur primarily during the first injection. These studies collectively confirm that while Dalmate offers significant clinical benefit, it must be administered with careful patient monitoring to manage known side effect profiles.

Frequently Asked Questions (FAQ)

Common questions about Dalmate (FAQ)


Q: How quickly does Dalmate start working after you take it?

Official information indicates that Dalmate (Flurazepam) is rapidly absorbed into the body after it is taken. The concentration of the medication in the blood typically peaks within 30 to 60 minutes, which is consistent with its intended use as an aid for sleep onset.


Q: What is the typical duration of action for Dalmate?

Dalmate produces an active substance in the body that has a long elimination half-life, meaning it stays in the body for a considerable time. According to official product information, this primary active component can have a half-life ranging from 47 to 100 hours, which may contribute to the medication's effects on sleep maintenance.


Q: Is it normal to feel groggy the morning after taking Dalmate?

Official labeling cautions that drowsiness, dizziness, and daytime impairment are potential side effects, particularly early in treatment. Official warnings advise caution regarding activities requiring mental alertness the next day due to the possibility of residual effects.


Q: Will I experience withdrawal symptoms if I stop taking Dalmate suddenly?

The official label warns that Dalmate can lead to physical dependence with continued use. Abruptly stopping the medication may cause acute and potentially severe withdrawal reactions. The product label emphasizes the need for a gradual dose reduction when discontinuing the medication.


Q: Can people with liver or kidney issues take Dalmate?

Patients with severe liver failure (hepatic insufficiency) should not take Dalmate. For those with less severe impairment of the liver or kidneys, official product information emphasizes the need for caution, and lower doses may be used in these patient groups.


Q: How long can a person safely take Dalmate?

Dalmate is indicated only for short-term use. Treatment should be limited to the shortest time possible, typically 7 to 10 days, and should not be used continuously for longer than four weeks. The clinical data supporting effectiveness has generally been collected over short periods, such as up to 28 consecutive nights.


Q: Can Dalmate affect the results of certain medical tests?

The drug's impact on the central nervous system may influence the results of certain neuro-diagnostic tests. Additionally, when Dalmate is taken with other medications, such as phenytoin, it may affect the laboratory levels of those drugs.


Q: What happens if I take Dalmate on an empty stomach?

Official product information states that Dalmate is rapidly absorbed after being taken orally with fluid. While the label does not explicitly detail effects related to the presence of food, it should be taken as directed by a healthcare provider.


Q: Does Dalmate affect my ability to drive or operate machinery the next day?

Yes, regulatory warnings advise caution about daytime impairment. Official warnings advise against driving or operating complex machinery until a person knows how the medication affects them.


Q: How is Dalmate eliminated from the body?

The active substance of Dalmate is primarily metabolized (broken down) in the liver. The resulting metabolites are then mainly excreted from the body through the urine.


Q: How often do people need to adjust their Dalmate dosage?

Dosage adjustments are specifically required at the start of therapy for certain populations, such as older adults. The official information notes that a failure of insomnia to remit after 7 to 10 days warrants a re-evaluation.


Q: Do I need to inform my dentist that I am taking Dalmate?

Regulatory guidance generally advises informing all healthcare providers, including dentists, about all medications being taken. This is due to the potential for additive Central Nervous System (CNS) depressant effects if other sedating medications are used during dental procedures.


Q: What are the possible interactions between Dalmate and birth control pills?

Oral contraceptives may decrease the body's ability to break down benzodiazepines like Dalmate. This could potentially increase the concentration of Dalmate in the blood, raising the risk of side effects. Patients taking this combination may require close observation.


Q: Can Dalmate be used for anxiety as well as sleep problems?

Dalmate is officially indicated as a hypnotic agent specifically for the short-term treatment of insomnia. Although the medication may have secondary calming properties, the drug is not officially indicated for anxiety.


Q: Does Dalmate cause weight gain or loss?

Weight changes are not listed among the commonly reported side effects in the primary official safety labeling for Dalmate. The most frequently noted adverse effects relate to the central nervous system.


Q: What's the difference between Dalmate and other common sleep aids?

Dalmate is a prescription medication belonging to the benzodiazepine class. This means it works by enhancing the natural calming effect of the GABA neurotransmitter in the brain. This mechanism of action is distinct from many non-prescription sleep aids.


Q: Why do doctors prescribe Dalmate instead of a different medication?

It is indicated for short-term treatment of insomnia, including difficulty falling asleep, frequent nocturnal awakening, or early morning awakening. Its use is based on its suitability for the patient’s specific type of insomnia and duration of need.


Q: What does the research say about the long-term effectiveness of Dalmate?

The effectiveness of Dalmate has not been definitively established for continuous use extending beyond 28 nights. Consequently, it is indicated only for short-term use.


Q: Is there a generic version of Dalmate available?

Dalmate is a brand name for the medication Flurazepam Hydrochloride. Generic versions containing the active ingredient Flurazepam are generally available, depending on market supply.


Q: Is it possible to develop a tolerance to Dalmate over time?

Tolerance, where the same dose produces less effect over time, is a known risk associated with benzodiazepines. This risk is consistent with the regulatory guidance that the medication should be used for the shortest time possible.


Q: Is it normal for Dalmate to make me feel dizzy?

Yes, official regulatory labeling lists dizziness and light-headedness as common adverse reactions associated with Dalmate use. Patients should be aware that these effects are possible.


Q: Can Dalmate cause strange dreams or nightmares?

Reports indicate that nightmares and hallucinations have occurred as possible side effects, although these are typically rare. The medication's effect on sleep patterns may sometimes lead to these unusual dream experiences.


Q: Are there any known severe allergic reactions associated with Dalmate?

While rare, serious hypersensitivity reactions, including angioedema (severe swelling of the throat or tongue), have been reported with this class of medication. These can be serious and require immediate medical attention.


Q: Is Dalmate safe to take if I have high blood pressure?

Official warnings and contraindications for Dalmate primarily focus on conditions such as severe respiratory, liver, and kidney impairment, as well as CNS issues. High blood pressure (hypertension) is not listed as a specific contraindication.


Q: What are the signs that Dalmate is working correctly?

According to the official drug usage information, the main signs of effectiveness include a noticeable reduction in the time it takes to fall asleep (sleep latency) and an increase in the total amount of time spent sleeping (sleep maintenance).


Q: Does Dalmate work the same for everyone?

No. Official regulatory information highlights that the drug's effects and how the body clears it can vary, especially in older adults and patients with impaired liver or kidney function. These patients may be more sensitive to the drug’s effects.


Q: Can Dalmate cause changes in mood or behavior?

Yes. The official label includes warnings about the possibility of new or worsening depression and potentially serious behavioral changes. These changes can include agitation, paranoia, and complex sleep-related behaviors.


Q: How is Dalmate stored properly at home?

The medication should be kept at a controlled room temperature, protected from light, and stored in a tightly closed container. Due to its classification as a controlled substance, it must be stored securely and kept out of the reach of children and pets.


Q: Are there different strengths of Dalmate tablets available?

Dalmate is supplied in capsule form, and the official regulatory documents confirm that it is available in two strengths: 15 mg and 30 mg.


Q: Is it possible to take Dalmate for only a few nights when needed?

Insomnia is often temporary or intermittent, and official labeling suggests that a short course of treatment is usually sufficient. Since Dalmate is intended for short-term use, any intermittent use should align with the overall prescribed duration.


Q: Can Dalmate worsen sleep apnea symptoms?

Yes. Dalmate is officially contraindicated in patients who have been diagnosed with Sleep Apnea Syndrome. This is because its CNS depressant effects can potentially worsen existing breathing difficulties during sleep.


Q: What are the main benefits of Dalmate besides just falling asleep faster?

Besides helping a person fall asleep quickly (sleep induction), the medication is also indicated for treating frequent awakenings during the night (sleep maintenance). It is indicated for both sleep induction and sleep maintenance.

How should Dalmate be stored and disposed of?

How to Store and Dispose of Dalmate (Flurazepam Hydrochloride)

Official regulatory documents define strict conditions for the storage and disposal of Dalmate capsules.

Storage Requirements

Detail Condition
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F). Permitted excursions extend to 30 C.
Protection Keep in a tightly closed container and protect from light.
Safety Rule KEEP OUT OF THE REACH OF CHILDREN and pets. Store in a safe place due to its classification as a Schedule IV Controlled Substance.

Disposal Instructions

Unused or expired Dalmate should be disposed of via an authorized drug take-back program. If a take-back option is unavailable, the capsules must be mixed with an unappealing substance (like used coffee grounds) in a sealed bag before being placed in the household trash. Personal information must be removed from the original label before discarding the container.

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

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