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Sonata (ZALEPLON)
Sonata (Zaleplon) is a small molecule gamma-Aminobutyric Acid A Receptor Agonist developed by Pfizer, targeting the GABA-A receptor alpha-1/beta-2/gamma-2 subunits. It is used to treat disorders of initiating and maintaining sleep, including initial insomnia. Sonata was FDA approved in 1999 and is now off-patent with multiple generic manufacturers. The drug has a short half-life of 1.1 hours and bioavailability of 31%. It is no longer under active patent protection.
At a glance
| Generic name | ZALEPLON |
|---|---|
| Sponsor | Pfizer |
| Drug class | gamma-Aminobutyric Acid A Receptor Agonist [EPC] |
| Target | GABA-A receptor alpha-1/beta-2/gamma-2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Disorders of initiating and maintaining sleep
- Initial insomnia
Boxed warnings
- WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS). Zaleplon capsules are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zaleplon capsules in a safe place to prevent misuse and abuse. Selling or giving away zaleplon capsules may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Common side effects
- Abdominal pain
- Asthenia
- Headache
- Malaise
- Photosensitivity reaction
- Anorexia
- Colitis
- Nausea
- Amnesia
- Confusion
- Depersonalization
- Dizziness
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy (PHASE3)
- A Pilot Randomized Controlled Trial of a Social Network Intervention (NA)
- Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application (NA)
- A Single Arm Pilot Trial of a Social Network Intervention (NA)
- Effect of Music on Surgical Performance During Artificial Intelligence-Based Simulation Training (NA)
- Effect of Music on Pain, Anxiety, and Behavior in Anxious Children During Molar Restorations (NA)
- The Effects of Different Time Reminder On Surgical Hand Scrubing (NA)
- The Study in Outpatient Medicine Using Nudges to Improve Sleep (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sonata CI brief — competitive landscape report
- Sonata updates RSS · CI watch RSS
- Pfizer portfolio CI