Flurazepam (Dalmane) is a long-acting benzodiazepine primarily prescribed for the short-term treatment of insomnia. It helps patients both fall asleep and remain asleep, addressing difficulty falling asleep, frequent nighttime awakenings, or waking too early in the morning.
Obtaining Flurazepam has become challenging due to severe supply disruptions stemming from manufacturer discontinuation and production hurdles in the generic drug market. This uncertainty has created widespread concern among patients and healthcare providers who depend on this specific pharmacological profile for managing chronic sleep disorders.
Current Availability Status and Manufacturer Updates
Generic Flurazepam Hydrochloride capsules (15 mg and 30 mg) have faced a volatile supply chain. The original primary supplier, Mylan (Viatris), formally discontinued production of both strengths, removing a substantial portion of the market supply. This discontinuation forced patients and prescribers to navigate a market with extremely limited options.
Currently, Flurazepam availability relies almost entirely on a single manufacturer, Chartwell Molecular Holdings LLC. Chartwell launched its supply of 15 mg and 30 mg capsules in November 2023. Relying on a solitary source often leads to localized shortages and allocation issues at the pharmacy level, making the medication difficult to find consistently across the country.
Rising Pharma Holdings, Inc., another potential generic manufacturer, has reported its supply as unavailable. The company does not anticipate having product available until late 2026. This extended timeline underscores the depth of the supply problem. Patients must often call multiple pharmacies to locate the drug and may face higher costs due to the constricted market.
Underlying Factors Driving Supply Constraints
The underlying reasons for the Flurazepam supply constraints are rooted in the economics and logistics of the generic drug industry. When a major manufacturer like Mylan decides to discontinue a product, it often signals a lack of financial incentive or a strategic shift away from that particular therapy area. Such discontinuations can leave a market gap that is difficult for remaining or new manufacturers to fill quickly.
The cited reason for the unavailability from Rising Pharma is a combination of a “Regulatory delay” and “manufacturing delays at the contract manufacturing facility.” Regulatory hurdles often involve slow approvals, inspections, or necessary changes to comply with updated quality standards at the production sites. Delays at a contract manufacturer, which often handles production for multiple generic companies, can affect the timeline for many different medications simultaneously.
Generic drug manufacturing is a low-margin business, and older medications like Flurazepam may not be prioritized over newer, more profitable compounds. This lack of financial incentive can lead to manufacturers exiting the market, which in turn reduces supply redundancy. When only one or two companies produce a drug, any minor disruption, such as equipment failure or a raw material shortage, can instantly trigger a nationwide supply crisis.
The active pharmaceutical ingredient (API) for Flurazepam, or other necessary components, may also be sourced from a limited number of facilities globally. If one of these API suppliers experiences quality control issues or a plant shutdown, it can ripple through the entire supply chain and halt production for months or even years. These complex global logistics mean that a firm date for a drug’s return is rarely provided by manufacturers, leaving patients in a state of indefinite uncertainty.
Treatment Alternatives and Consultation Guidelines
For patients unable to obtain Flurazepam, it is imperative to consult with a healthcare provider immediately to discuss alternative treatment strategies. Abruptly stopping Flurazepam is strongly discouraged due to the risk of withdrawal symptoms and rebound insomnia, which can be severe. The drug’s active metabolite, N-desalkylflurazepam, has an extremely long half-life, sometimes lasting up to 100 hours, meaning the effects of discontinuation can be delayed and prolonged.
A physician may recommend switching to another benzodiazepine hypnotic that is currently available, such as Temazepam (Restoril), Triazolam (Halcion), or Quazepam. These alternatives have different half-lives and may not provide the same long-lasting effect as Flurazepam, requiring careful dosage adjustment. The choice of an alternative depends heavily on the specific nature of the patient’s insomnia, whether it involves difficulty falling asleep or maintaining sleep.
Non-benzodiazepine receptor agonists, often called “Z-drugs,” like Zolpidem (Ambien) or Eszopiclone (Lunesta), are also common alternatives. These medications interact with the same brain receptors but have a different chemical structure and generally shorter half-lives, which may reduce next-day sedation. Switching from a long-acting drug like Flurazepam to a shorter-acting hypnotic must be done with medical oversight to ensure a safe and effective transition.
The goal of consultation should be to establish a medically supervised tapering schedule or a direct switch to a suitable alternative. Patients should also discuss non-pharmacological interventions, such as cognitive behavioral therapy for insomnia (CBT-I), which is considered a highly effective, long-term solution for chronic sleep issues.