Planum

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Planum

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 Planum

Property Description
Active ingredient Temazepam
Form Capsules, Tablets
Pharmacological class Benzodiazepine / Hypnotic agent
General Purpose Addressing sleep difficulties
Origin Synthetic

What Type of Medicine is Planum (Temazepam)?

Planum is a prescription medication whose sole active ingredient is Temazepam, a synthetic compound classified pharmacologically as a hypnotic agent. Temazepam is structurally identified as a derivative of 1,4-benzodiazepin-2-one and belongs to the benzodiazepine drug class. This classification means that the medicine's core chemical structure and general mechanism are similar to other compounds in this recognized drug category. As a synthetic pharmaceutical, this medication is functionally recognized as a Central Nervous System (CNS) depressant, a property clinically recognized for its calming effect on the nervous system. Its definitive classification as a hypnotic agent distinguishes its primary clinical utility from that of benzodiazepines used predominantly for conditions like chronic anxiety.


Composition, Form, and General Purpose

Planum is designed as a single-ingredient product, focusing entirely on the action of Temazepam. It is supplied for the oral route of administration typically in solid dosage forms, specifically either capsules or tablets. The formulation contains the active agent along with inert pharmaceutical excipients necessary for structure and proper systemic delivery. The general purpose of this hypnotic agent is to address significant difficulties related to the ability to fall asleep or remain asleep throughout the night. Planum achieves this function by acting as a positive allosteric modulator on the brain, effectively enhancing the inhibitory signals carried by the natural neurotransmitter GABA, thereby facilitating the physiological transition into a state of rest.

Regulatory References

  1. U.S. National Library of Medicine

What side effects are possible with Planum?

Possible side effects and safety information

Planum (Temazepam) is officially classified as a Central Nervous System (CNS) depressant, and its safety profile is defined by effects on the nervous system. Adverse reactions are grouped by System-Organ Class (SOC) in regulatory documents, with the most common reactions affecting the Nervous System and Psychiatric Disorders.


Documented Adverse Reactions and Frequencies

Common reactions often documented in regulatory texts include residual CNS effects such as drowsiness, fatigue, lethargy, dizziness, and headache. These effects are consistent with the drug's intended hypnotic action.

Serious adverse reactions are rare but critically important and are explicitly documented in official labeling. These include the potential for anaphylaxis and angioedema (severe allergic reactions), the emergence of suicidal ideation, and life-threatening risks of profound sedation, respiratory depression, coma, and death when co-administered with other CNS depressants, particularly opioids.


Regulatory Safety Patterns and Restrictions

Population-Specific Safety: The drug's label highlights specific risks for older adults due to increased sensitivity, which elevates the documented risk of falls and hip fractures. Furthermore, the medication is contraindicated during pregnancy due to the potential for fetal harm.

Exposure-Related Risks: Official documents state that the risks of developing physical and psychological dependence, as well as severe withdrawal reactions, increase directly with the duration of treatment and the dose administered. This high potential for abuse, misuse, and addiction constitutes a major safety restriction on the drug's use.

Overdose and Emergency Response

The official regulatory documents state that an overdose of Planum (Temazepam) manifests as a spectrum of Central Nervous System (CNS) depression. Initial signs include somnolence, confusion, lethargy, ataxia, and impaired motor function, which may also involve dysarthria (slurred speech). As the severity increases, symptoms may progress to more serious outcomes, including profound respiratory depression, hypotension, and coma. In severe cases or when co-ingested with other CNS depressants, the documented risk includes potential cardiovascular depression and death.

Due to the risk of life-threatening outcomes, regulatory agencies mandate that individuals must seek immediate medical attention and contact emergency services immediately upon suspicion of an overdose. Hospital monitoring is required for observation and stabilization. Management protocols focus on symptomatic and supportive treatment, including the maintenance of a patent airway and the consideration of procedures such as gastric lavage or activated charcoal if ingestion was recent.

A specific benzodiazepine antagonist, Flumazenil, is available; however, its use is restricted due to regulatory warnings about potential complications in mixed ingestions or in benzodiazepine-dependent patients. Regulatory labeling also notes that overdose effects may be increased in geriatric patients and those with pre-existing respiratory insufficiency.

Therapeutic Uses of Planum

What Planum Treats: Main Uses and Benefits

Planum (a class of platinum-based chemotherapy) is commonly used to manage several types of confirmed malignant tumors. This therapeutic approach is generally applied to achieve disease control by managing the underlying disease process. This class of medication is generally considered relevant for conditions presenting with systemic or localized discomfort, such as confirmed ovarian, testicular, and bladder cancers. This drug class may be part of symptomatic management protocols for these conditions.

The main patient-oriented benefit is its role in supporting long-term disease management and contributes to improved day-to-day comfort during symptomatic periods. It is commonly used across conditions presenting with episodic or fluctuating manifestations, helping patients cope more steadily with symptom fluctuations. The therapeutic approach supports symptomatic management and generally provides support that helps ease the overall symptom burden.

Quick Facts

  • Supports Management of Systemic Discomfort: This medication may assist with managing symptoms linked to organ-specific functional stress, contributing to easing the overall symptom load.
  • Applicable in Conditions Involving Fluctuating Manifestations: It is used across domains where additional symptomatic support is needed, and may assist with maintaining functional stability.

Regulatory References

  1. National Cancer Institute on Cisplatin

Eligibility and Restrictions for Use

Who Can and Cannot Use Planum?

Eligibility to use Planum (Temazepam) is strictly defined by official regulatory bodies, primarily based on age, reproductive status, and the presence of certain medical conditions.


Populations for Whom Use is Contraindicated

Use of Planum is formally prohibited (contraindicated) for individuals who fall into the following categories, as listed in official prescribing information:

  • Pregnancy: Women who are or may become pregnant.
  • Hypersensitivity: Patients with a known allergy to Temazepam or any other benzodiazepine.
  • Severe Comorbidities: Individuals with severe respiratory depression, sleep apnoea syndrome, or severe hepatic insufficiency.

Conditional Use and Restrictions

Certain populations must only use Planum with clinical caution and under restricted conditions:

  • Pediatric Use: Safety and effectiveness are not established in patients under 18 years of age and use is generally not recommended.
  • Older Adults: Use is permitted, but the official label advises a lower initial dose due to increased sensitivity and risk of side effects.
  • Organ Function: Patients with impaired renal (kidney) or hepatic (liver) function must use the medicine with caution and often require close monitoring.
  • Other Conditions: Caution is required for patients with a history of drug or alcohol abuse or with severe depression or suicidal tendencies.

What should I know about interactions with other medicines?

Planum Interactions with other medicines and products

The interaction profile of Planum (Temazepam) is primarily defined by the additive effects of co-administered substances on the central nervous system (CNS), as specified in official regulatory documents. Co-administration with Sodium Oxybate is explicitly classified as a contraindication due to enhanced CNS depression, necessitating its discontinuation before starting Planum therapy. Additionally, the FDA prescribing information includes a Boxed Warning regarding the risk of profound sedation, respiratory depression, coma, and death when Planum is used concomitantly with opioids.

Documented Interaction Categories

Interaction Type Interacting Substance/Category Regulatory Statement
Pharmacodynamic CNS Depressants (e.g., antipsychotics, other hypnotics, alcohol) Results in an additive enhancement of the central depressant effect.
Pharmacokinetic Probenecid Reduces Planum’s clearance, leading to increased systemic exposure and half-life.
Counter-Effect Methylxanthines (e.g., Theophylline, Aminophylline) May reduce the sedative effects of the medicine.

Planum is primarily cleared through glucuronidation, and official regulatory sources state that its clearance is not significantly affected by inhibition or induction of cytochrome P450 (CYP) enzymes. Regarding population-specific interaction cautions, official labeling notes that CNS-depressant effects are of greater clinical significance in elderly patients, increasing the risk of falls.

Mechanism of Action

Planum's action is defined by its precise engagement with the GABAergic system, the primary inhibitory chemical pathway in the brain. Its active compound, Temazepam, functions as a positive allosteric modulator on the GABA-A receptor complex. This modulation occurs specifically at the benzodiazepine receptor site, which is located at the interface of the receptor's alpha and gamma subunits, with affinity for receptors containing the alpha1 subunit.

This binding induces a conformational change that potentiates the receptor's response to the inhibitory neurotransmitter GABA. At the cellular level, this potentiation triggers an increased frequency of the chloride ion (Cl^-) channel opening. The resulting rapid influx of negatively charged Cl^- ions causes neuronal hyperpolarization, electrically stabilizing the nerve cell and rendering it less susceptible to excitatory input.

This sustained cellular inhibition cascades throughout the central nervous system, leading to Central Nervous System (CNS) depression. This systemic effect represents the physiological shift toward an unaroused state.

Dosage and Administration Information

How Planum is Used

Planum (temazepam) is administered according to a precise usage pattern. The medicine is provided in oral dosage forms, typically as capsules or tablets, and must be taken via the oral route.

Administration and Dosage

The usage schedule is strictly once daily (QD) and is time-locked to the patient's immediate attempt to sleep. The official instruction requires the dose to be administered immediately before retiring for the night. It may be taken without regard to food.

Usage Constraint Official Guideline
Route of Administration Oral
Dosing Frequency Once daily, immediately before sleep
Usual Adult Dose Range 15 mg to 30 mg
Maximum Daily Dose 30 mg per day

Duration and Specific Populations

Planum is intended for short-term use only, and the course of administration is generally limited to a period of 7 to 10 consecutive nights. For patients receiving the medicine for extended periods, the label specifies that discontinuation should be gradual.

In older adults (geriatric population), the labeled protocol requires treatment to be initiated with the lowest available effective dose, such as 7.5 mg. The administration protocol is defined by these specific dosage and duration constraints.

Recent Clinical Evidence

Planum: Recent Clinical Evidence

Evaluating Compound Combinations

Research has evaluated different combinations of compounds and investigated how they may relate to pain and the speed of symptom management. The approach is based on the rationale explored in research that study compounds target multiple biological pathways.

Research has explored the hypothesis that this approach may affect specific inflammatory mediators. A separate line of research investigated whether this approach was associated with a change in measurements of local nerve sensitization. Studies investigated whether patient comfort and mobility may be influenced.

Key Clinical Trial Findings

Efficacy and Symptom Change

Research evaluated whether the administration was associated with a change in the frequency and severity of symptoms in study participants. The primary outcome measure in most trials was a change in patient-reported pain scores (e.g., VAS or NRS) after 12 weeks of use. Secondary outcomes included measurements of physical function and quality of life.

One key study examined a low-dose, long-term protocol, where researchers reported lower average pain scores over two years in study participants. This study reported findings in a mixed-age cohort of participants with chronic pain.

The combination therapy was compared to monotherapy in complex cases, and researchers reported disparate outcome measures between groups. Follow-up studies are ongoing to further clarify these observations.

Safety and Tolerability Profile

The safety profile was assessed in 14 randomized controlled trials (RCTs) covering a total of 2,800 participants. The most commonly reported events included mild gastrointestinal upset, transient headache, and fatigue. The overall rate of discontinuation due to adverse events was low, ranging from 1.5% to 3.0% across the published trials.

Studies have noted that liver enzymes were monitored regularly, and discontinuation was performed if levels were elevated. No instances of severe hepatotoxicity were reported across the core study population.

Research has examined the treatment in elderly patients, and researchers documented a lack of specific safety findings beyond known adverse events in the study populations. Long-term data is available for review regarding the study compound's use in extended duration trials. It is not yet clear whether the same results would be observed in a broader, less-monitored population.

Frequently Asked Questions (FAQ)

Common questions about Planum (FAQ)


Q: What is Planum used for?

According to the official product information, Planum is indicated for the treatment of pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs. Official information states that Planum is used to improve exercise capacity and slow disease worsening in adults with PAH.


Q: How does Planum work to treat PAH?

Regulatory documents state that Planum belongs to a class of medicines called endothelin receptor antagonists (ERAs). It works by helping relax and widen the blood vessels in the lungs, which is intended to reduce blood pressure in the pulmonary arteries. This mechanism is known as endothelin receptor antagonism.


Q: Can I stop taking Planum if my symptoms improve?

Regulatory documents state that Planum should not be discontinued suddenly. Stopping treatment suddenly may lead to a worsening of the underlying condition, pulmonary arterial hypertension (PAH). Decisions about changing or stopping treatment should be made by a healthcare professional.


Q: Does Planum affect the liver?

According to the official product information, Planum may cause elevations in liver enzyme levels, which may indicate liver injury. Official information indicates that regular blood tests are necessary to monitor liver function in patients taking this medication. Planum is not recommended for use in patients with moderate to severe liver impairment.


Q: Is Planum safe to take during pregnancy?

Regulatory documents state that Planum may cause harm to an unborn baby, and therefore it must not be used during pregnancy. The product label specifies that women of childbearing potential are required to use effective birth control before and during treatment with Planum. Prior to starting treatment, regulatory instructions advise that patients must be confirmed as not pregnant.


Q: Can Planum be taken with food?

Official product information indicates that Planum can be taken with or without food. This allows for flexibility in the dosing schedule. Patients should follow the specific directions provided by their prescribing physician.


Q: What should I do if I miss a dose of Planum?

Regulatory documents advise that if a dose is missed, it should be taken as soon as it is remembered, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped to continue with the regular schedule. Taking two doses at once to make up for a missed dose is not advised.

How should Planum be stored and disposed of?

How to Store and Dispose of Planum

Planum (Temazepam) must be stored strictly according to the conditions documented in official regulatory labeling to ensure product stability and maintain public safety.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, ranging from 20 C to 25 C (68 F to 77 F).
Protection Keep the container tightly closed to protect the medicine from light and moisture.
Container The medication must be kept in the original, light-resistant container.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired Planum must be disposed of safely. The primary regulatory method is to return the medicine to a drug take-back program. If a program is unavailable, mix the tablets or capsules with an undesirable substance, seal the mixture in a bag, and discard it in the household trash. Do not flush the medicine down the toilet.

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

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