Product image of Oniria (Zolpidem Tartrate) supplied by GNH India

Oniria

Active Ingredient:
Zolpidem Tartrate
Origin:
EU

Oniria (Zolpidem Tartrate)

Zolpidem tartrate, the active ingredient in Oniria, is a non‑benzodiazepine hypnotic presented as a tablet for oral use. It is indicated for the short‑term treatment of insomnia in adults. GNH India supplies Oniria as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

GNH India supplies Oniria as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Itf Hellas S.A.

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Indications & Clinical Uses

Zolpidem tartrate is used to manage sleep initiation problems within the broader category of insomnia disorders.

  • Insomnia (sleep onset insomnia): Helps patients fall asleep more quickly.
  • Transient insomnia due to stress or jet‑lag: Provides short‑term relief of difficulty falling asleep.
  • Primary sleep disorder: Improves overall sleep latency in diagnosed primary insomnia.

How It Works

  • Zolpidem tartrate binds selectively to the benzodiazepine‑binding site of the GABA‑A receptor complex, enhancing the inhibitory effect of GABA. This potentiation increases chloride ion influx, leading to neuronal hyperpolarisation and a reduction in central nervous system activity that promotes sleep onset.

Side Effects

Adverse reactions to zolpidem are reported across a range of frequencies.

Common Side Effects

  • Drowsiness: Persistent sleepiness during waking hours.
  • Dizziness: Light‑headed sensation, especially when standing quickly.
  • Headache: Mild to moderate head pain.
  • Nausea: Stomach discomfort or urge to vomit.
  • Dry mouth: Reduced salivation.
  • Unpleasant taste: Metallic or bitter sensation in the mouth.

Serious or Rare Side Effects

  • Complex sleep‑related behaviours: Sleepwalking, sleep‑driving or other activities while not fully awake.
  • Allergic reactions: Rash, itching, swelling, or difficulty breathing.
  • Depression or mood changes: Worsening depressive symptoms or new onset mood disturbances.
  • Hallucinations: Visual or auditory disturbances.
  • Suicidal thoughts: Emergence of suicidal ideation.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

When prescribing zolpidem, clinicians should consider several safety aspects.

  • Assess sleep disorder duration: Confirm that use is limited to short‑term therapy (typically ≤ 7 days).
  • Evaluate comorbid conditions: Review psychiatric, respiratory or hepatic disorders before initiating therapy.
  • Avoid alcohol: Concomitant alcohol use can amplify sedative effects and increase risk of respiratory depression.
  • Monitor for dependence: Watch for signs of tolerance, misuse or withdrawal with prolonged use.
  • Counsel on next‑day activities: Advise patients to ensure a full night’s sleep before driving or operating machinery.
  • Store at ambient temperature: Keep tablets in the original container, protect from moisture and heat.

Avoid Interactions

Zolpidem may interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Opioids: Combined use can increase risk of profound sedation and respiratory depression.
  • Central nervous system depressants: Concurrent benzodiazepines or barbiturates may cause excessive sedation.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): May raise zolpidem plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Antidepressants (especially SSRIs): May augment sleep‑related side effects.
  • Antihistamines: Can enhance drowsiness.
  • Alcohol: Even moderate intake can intensify sedation and impair cognition.

Frequently Asked Questions

Oniria contains zolpidem tartrate, which is prescribed for the short‑term management of insomnia, specifically to help adults fall asleep more quickly when they have difficulty initiating sleep.

Zolpidem tartrate binds selectively to the benzodiazepine site of the GABA‑A receptor, enhancing GABA‑mediated chloride influx. This increased inhibitory signalling reduces neuronal activity in the brain, facilitating sleep onset.

The appropriate dose of Oniria is determined by a qualified prescriber based on the patient’s clinical condition, age, and other medications. Dosage instructions are provided on the prescription label.

Zolpidem is classified as pregnancy category C and should only be used if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk, so breastfeeding mothers should consult their healthcare provider before use.

To order Oniria, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and import documentation.

Oniria (zolpidem) is a non‑benzodiazepine hypnotic that generally has a shorter half‑life and fewer next‑day residual effects compared with traditional benzodiazepines such as temazepam. It is often preferred for brief, low‑dose regimens aimed at sleep initiation.

Store tablets at ambient temperature, below 25 °C, in the original container. Protect them from moisture, direct sunlight and excessive heat to maintain product stability.

Oniria is taken orally, usually as a single tablet shortly before bedtime. Patients should ensure they have the opportunity for a full night’s sleep (7–8 hours) after taking the medication.

Serious risks include complex sleep‑related behaviours such as sleepwalking or sleep‑driving, allergic reactions, severe skin reactions, and emergence of suicidal thoughts. Any such events require immediate medical attention.

Oniria is contraindicated in patients with known hypersensitivity to zolpidem, severe hepatic impairment, or a history of complex sleep‑related behaviours. Caution is also advised for individuals with depression, respiratory disorders, or those taking other CNS depressants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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