For patients managing chronic sleep disorders such as narcolepsy or obstructive sleep apnea (OSA), maintaining alertness throughout the day can be life-changing. One of the most promising wakefulness-promoting medications globally is Solriamfetol, marketed under the brand name Sunosi.
However, a common question from patients and clinicians alike is — “Is Solriamfetol available in India?”
Given India’s complex regulatory environment for central nervous system (CNS) stimulants and wakefulness agents, understanding where Solriamfetol stands legally and clinically is essential. This article, written from the standpoint of medical transparency and patient education, breaks down its availability, regulation, and viable alternatives for those seeking similar therapies.
What Is Solriamfetol?
Pharmacological Profile
Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), designed to enhance alertness and counter excessive daytime sleepiness.
Unlike traditional stimulants such as amphetamine or methylphenidate, it has a lower abuse potential and a cleaner pharmacokinetic profile.
Approved by the U.S. Food and Drug Administration (FDA) in 2019, Solriamfetol (Sunosi) is indicated for adults with narcolepsy or sleep apnea-related fatigue. Clinical trials have demonstrated that it significantly improves wakefulness and cognitive alertness within hours, with sustained effects lasting up to 9 hours per dose.
For comparison, its mechanism differs from modafinil and armodafinil — it targets both norepinephrine and dopamine reuptake more directly, potentially offering a stronger stimulating effect.
Solriamfetol’s Legal Status and Availability in India
Not Currently Approved by CDSCO
As of October 2025, Solriamfetol is not approved for marketing or sale in India by the Central Drugs Standard Control Organization (CDSCO) — the governing body for pharmaceuticals under the Ministry of Health and Family Welfare.
There is no listing for Solriamfetol or Sunosi on the CDSCO’s official list of approved drugs, and no domestic or imported license has been issued for its distribution.
This means Solriamfetol is not legally available through Indian pharmacies, hospitals, or telemedicine providers. Importing it privately, even for personal use, would require a valid medical prescription and prior approval under Rule 36 of the Drugs and Cosmetics Act, 1940.
Why It’s Not Yet Marketed
Several factors explain the delay in Solriamfetol’s introduction to the Indian market:
- Regulatory prioritization — wakefulness agents are scrutinized for potential misuse.
- Existing alternatives — India already has a large market for modafinil and armodafinil, which cover similar indications.
- Patent and distribution rights — Jazz Pharmaceuticals, the manufacturer, has not yet partnered with Indian distributors.
In contrast, countries such as the United States, United Kingdom, and Australia have authorized Solriamfetol under controlled prescription categories.
Real-World Patient Perspective
Patients in India who experience narcolepsy or chronic sleepiness often depend on generic modafinil formulations, such as Modalert, Modvigil, or Waklert.
These are produced by trusted Indian pharmaceutical companies like Sun Pharma, HAB Pharma, and Intas Pharmaceuticals, all of which have long histories of FDA and WHO compliance.
In clinical practice, physicians often find modafinil and armodafinil sufficient for most cases, though they note Solriamfetol’s stronger and more predictable onset in international studies.
A patient case from Mumbai illustrates this well — a 32-year-old IT professional with sleep apnea reported that switching from modafinil to Solriamfetol (obtained abroad) resulted in “a smoother, more sustained alertness without the afternoon crash.” However, she faced difficulty continuing the therapy due to import restrictions and high cost.
Comparison with Similar Drugs
| Medication | Mechanism | Legal Status in India | Abuse Potential | Approx. Price (USD / 30 tabs) |
|---|---|---|---|---|
| Modafinil (Modalert) | Dopamine reuptake inhibitor | Approved | Low | $30–50 |
| Armodafinil (Waklert) | R-enantiomer of Modafinil | Approved | Low | $40–60 |
| Solriamfetol (Sunosi) | Dopamine/Norepinephrine reuptake inhibitor | ❌ Not approved | Very low | $200–300 (import only) |
| Pitolisant (Wakix) | Histamine-3 inverse agonist | ❌ Not approved | Minimal | $250–400 (import only) |
As the table shows, India’s local options remain limited to modafinil-based agents, both of which are well-tolerated and legally distributed. Solriamfetol’s stronger wake-promoting action is available only abroad — notably in the U.S., U.K., and EU markets.
External Evidence and Official References
According to the U.S. FDA’s 2019 approval report on Solriamfetol (Sunosi), the drug demonstrated a “significant increase in mean sleep latency” in the Maintenance of Wakefulness Test (MWT) among narcoleptic patients (FDA Label PDF).
Similarly, the European Medicines Agency (EMA) approved Solriamfetol in 2020, emphasizing its safety and controlled cardiovascular risk profile in adults with obstructive sleep apnea (EMA Assessment Report).
Both agencies note that Solriamfetol’s side effects — primarily headache, insomnia, and anxiety — were dose-dependent and generally mild.
Alternatives and Broader Context
Until Solriamfetol becomes available in India, patients can consider the following legal and accessible options under physician guidance:
- Modafinil (Modalert, Modvigil) — effective for both OSA and narcolepsy-related sleepiness.
- Armodafinil (Waklert, Artvigil) — longer-acting, often preferred for shift work disorder.
- Lifestyle modifications — improving sleep hygiene, regular light exposure, and CPAP adherence in OSA.
Additionally, India’s strong pharmaceutical manufacturing base allows for affordable generic formulations exported globally. While Solriamfetol may enter the market in the coming years, patients are advised to avoid purchasing unapproved imports online, as these may be counterfeit or improperly labeled.
Summary and Takeaway
To summarize:
- Solriamfetol is not currently approved for use or sale in India.
- Its manufacturer, Jazz Pharmaceuticals, has not obtained CDSCO registration.
- Importing it without authorization may violate the Drugs and Cosmetics Act.
- Safer, legal alternatives — including Modafinil and Armodafinil — are widely available and clinically effective.
As India continues to expand its access to advanced psychopharmacological agents, Solriamfetol may eventually become part of its therapeutic landscape — but for now, patients should rely on approved, physician-supervised options.
Disclaimer
This article is intended for educational and informational purposes only. It does not constitute medical, diagnostic, or legal advice.
Always consult a qualified healthcare professional before starting or changing any medication regimen.
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