Zaleplon Capsules
Healthy Inc is a specialized global supplier and exporter of advanced central nervous system (CNS) and sleep medicine therapeutics. We provide high-purity Zaleplon Capsules (5 mg / 10 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Non-Benzodiazepine Hypnotic (Z-Drug)” is a high-value export to sleep medicine centers, psychiatric hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a highly targeted intervention for sleep-onset insomnia and middle-of-the-night awakenings.
Product Overview
This formulation contains Zaleplon, a non-benzodiazepine hypnotic from the pyrazolopyrimidine class.
The “Rapid-Clearance Hypnotic” Specialist:
- Mechanism (Selective GABA-A Modulation): Like other Z-drugs, Zaleplon interacts with the gamma-aminobutyric acid-A (GABA-A) receptor complex. However, it binds highly selectively to the omega-1 (alpha-1) subunit of the receptor. This specific targeting powerfully induces sedation and sleep without heavily triggering the subunits responsible for muscle relaxation or anti-convulsant effects, making it an exceptionally pure hypnotic.
- The Ultra-Short Half-Life Advantage: Zaleplon has an incredibly rapid elimination half-life of approximately 1 hour. This means it clears the patient’s system almost completely before morning. It is engineered specifically for patients who struggle to fall asleep, rather than those who struggle to stay asleep.
- Middle-of-the-Night Rescue: Because it clears so rapidly, Zaleplon is uniquely approved to be taken in the middle of the night if a patient wakes up and cannot get back to sleep, provided they have at least 4 hours of sleep time remaining before they must be active.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed in moisture-resistant Alu-PVC or Alu-PVDC blister strips.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Zaleplon USP/BP | 5 mg | Geriatric Dosing / Low Body Weight / Mild Hepatic Impairment |
| Zaleplon USP/BP | 10 mg | Standard Adult Dose for Sleep-Onset Insomnia |
| Excipients | Microcrystalline Cellulose / Pregelatinized Starch | Diluent / Binder (Ensures rapid gastric dispersion) |
*Pack Sizes: 10×10 Alu-PVC Blisters or Bulk Jars of 500/1000 Capsules for institutional dispensing.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 151319-34-5 |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-PVC or Alu-PVDC Blisters. |
| Storage | Store below 30°C in a dry place. Protect strictly from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Rapid Dissolution Profiling: Because Zaleplon is utilized for immediate sleep induction, the capsule formulation utilizes optimized disintegrants to ensure the capsule shell ruptures and releases the API within minutes of entering the stomach, facilitating a rapid onset of action (typically 15 to 30 minutes).
- Low-Dose Uniformity: Advanced geometric dilution and high-shear granulation are utilized to ensure absolute content uniformity across the 5 mg and 10 mg capsule strengths, ensuring predictable, non-toxic CNS depression.
Therapeutic Indications (Human Use)
Indicated for the short-term management of specific sleep architecture disorders:
- Sleep-Onset Insomnia: Short-term treatment of insomnia characterized strictly by difficulty falling asleep.
- Middle-of-the-Night Awakenings: Can be utilized for patients who awaken in the middle of the night and struggle to return to sleep (provided ≥4 hours of sleep time remain).
Dosage & Administration
Recommended Dosage (Strictly as per Sleep Specialist/Psychiatrist):
- Administration (TIMING): Must be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
- Dietary Restriction: Taking Zaleplon with or immediately after a high-fat/heavy meal severely delays its absorption and drastically reduces its effect on sleep latency. It is best taken on an empty stomach.
- Standard Adult Dose: 10 mg at bedtime.
- Elderly/Debilitated Adults: Must be initiated at 5 mg to reduce the risk of excessive CNS depression, confusion, and falls.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Complex Sleep Behaviors): Z-drugs, including Zaleplon, can cause severe parasomnias. Patients may engage in complex behaviors while entirely asleep, such as “sleep-driving,” making food, or making phone calls, with total amnesia of the event the next morning. If this occurs, the drug must be discontinued immediately.
- CNS Depression & Next-Day Impairment: Although the half-life is very short, patients must not engage in hazardous occupations requiring complete mental alertness (like operating machinery) if they feel drowsy the morning after administration.
- Abuse & Dependence: Zaleplon is a controlled substance (Schedule IV equivalent in many jurisdictions). It carries a risk of psychological and physical dependence, and should generally be prescribed for short durations (7 to 10 days).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for CNS and Sleep Medicine Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.