DSIP

DSIP stands for delta sleep-inducing peptide. FDA calls it emideltide ^{[5] [6]}. It is a chain of nine amino acids ^[6]. Amino acids are the building blocks of proteins. Scientists first took it from rabbit blood in 1977 ^[21]. Its name comes from delta waves, brain waves that rise in one kind of sleep ^[6].

DSIP is part of no FDA-approved drug and has no official US quality standard ^[6]. It comes as a free base and as an acetate salt, and FDA treats them as two different substances ^[6]. No country FDA searched has registered it as a drug ^[6]. In the US, clinics and websites sell it as shots and nose sprays ^[6]. They promote it for sleep, stress, pain, cancer, brain diseases, and drug or alcohol withdrawal ^[6].

DSIP is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 ^{[1] [2]}. That is not approval, and it does not make compounding lawful. FDA reviewed it for opioid withdrawal, long-term insomnia and narcolepsy, a disorder of sudden sleep ^{[4] [5]}. Websites and clinics sell it for sleep, stress, pain and other uses ^[6]. Checked 23 October 2026.

Category 2 is FDA's list of substances that raise significant safety concerns. Category 1 is the list of substances under evaluation, which pharmacies may use while FDA reviews them ^{[2] [3]}. The groups that nominated DSIP withdrew their nominations, so it came off Category 2 ^{[1] [6]}. FDA then reviewed both forms on its own ^[6]. FDA's scientists found that the evidence weighs against adding either form to the list ^{[6] [8]}.

On 24 July 2026, FDA's Pharmacy Compounding Advisory Committee met on DSIP, under the name emideltide ^{[4] [5] [7]}. One legal report says the committee voted 6 to 7, with 1 member abstaining, and did not recommend adding it ^[12]. A news report says it was the only peptide the committee voted down ^[22]. FDA's meeting page does not show the vote ^[5]. A vote against DSIP is still only advice, just as a vote for it would be ^[12]. FDA decides by writing a rule, after public comment ^{[12] [23]}.

Until FDA acts, a pharmacy that makes DSIP is outside federal law ^{[3] [10]}. In 2020, FDA warned a compounder that DSIP was not eligible for compounding ^[10]. The same year, that compounding pharmacy pleaded guilty to distributing unapproved new drugs, DSIP among them ^[11].

The evidence grade is insufficient: a few small studies in people exist, most from the 1980s, and they disagree ^[6]. FDA found too little evidence that DSIP helps any of the three uses it reviewed ^[6]. Every study in people gave DSIP into a vein. None tested shots under the skin, the way it is sold ^[6].

Insomnia: in a 1992 Amsterdam study, 16 adults with long-term insomnia got DSIP or a placebo, a dummy treatment ^[14]. The effects were weak, and the authors said DSIP is not likely to be of major benefit ^[14]. In a 1987 study, adults with insomnia got DSIP on some nights and a placebo on others ^[15]. The authors found the gain in sleep was of little clinical value ^[15]. A third 1987 study, in 14 adults, reported much better sleep and daytime alertness ^[16]. FDA notes that this study had no true placebo group, so its results are hard to judge ^[6].

Narcolepsy: one 1984 report describes a single man with narcolepsy. He had fewer sleep attacks while taking DSIP ^[17]. FDA says one case is too little to judge ^[6].

Withdrawal: in a 1984 Geneva study, 107 hospital patients in alcohol or opioid withdrawal got DSIP ^{[6] [18]}. The authors report that symptoms went away or eased in most of them ^[18]. The study had no comparison group, and FDA says its results should be read with caution ^[6].

Animals: in rats, DSIP made sleep last longer ^[19]. In another rat study, blocking the body's own DSIP stopped a rise in slow-wave sleep after the rats lost sleep ^[20]. FDA notes sleep effects in rabbits, cats and rats ^[6]. A 2006 review says the link between DSIP and sleep was never clearly shown ^[21].

There is no legal way to get DSIP in the US today ^[6]. No approved drug contains it. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. DSIP is neither ^{[3] [6]}. FDA could still add it by writing a rule, but its committee advised against that ^[12].

No country FDA searched has registered DSIP as a drug ^[6]. Any open trial that gives DSIP would appear in the trials block below, with the date the official registry was last checked. FDA notes that approved drugs already exist for insomnia, narcolepsy and opioid withdrawal ^[6].

People who use DSIP in the US get it in three main ways ^[6]. The first is websites that sell it as shots or nose sprays ^[6]. FDA treats products like these as unapproved new drugs when the seller's own words show they are meant for people ^[9]. The second is pharmacies. From 2018 to 2020, one compounding pharmacy made and sold products with DSIP, and it later pleaded guilty ^{[6] [11]}. The third is clinics. Neurology clinics, concierge doctors, medical spas and wellness clinics market DSIP shots and nose sprays ^[6].

In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no published tests of DSIP powder for impurities, clumps or germ toxins ^[6]. None of the websites FDA searched say which form of DSIP they sell ^[6]. FDA's file of harm reports held none for DSIP as of March 2024 ^[6].